Biomedical Engineering Career Careers in the United States

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Imaging Biomedical Technician (BMET)

TEMPORARY BIOMEDICAL ENGINEERING TECHNICIAN (BMET) (General Imaging Equipment) STATEMENT OF WORK Temporary staffing needed on a full-time basis (40 hours per week) for one (1) Biomedical Engineering Technician (BMET) for approximately a 6-12 month period. SUPERVISORY CONTROLS : Works under specific guidelines and supervision of the Supervisory Biomedical Engineering Technician (BMET). All work assignments will be assigned thru the Supervisory BMET or Biomedical Program Specialist. Temporary BMET is technically responsible for the quality of work accomplished. DUTIES : First response level maintenance, repairs, and preventive maintenance (PM) for general imaging equipment (see specifics below). Finds solutions to failures of assigned equipment in the most cost efficient and expedient manner. Performs repairs using accepted repair practices while maintaining high standards of equipment performance and safety. PM inspections shall be in accordance with manufacturer and Biomedical Engineering?s standard procedures Coordinates with vendor service representatives in providing PM, repair, and/or parts acquisition for assigned equipment covered under a service contract. Assists in-house BMETs with maintenance and repair of complex electronic and medical equipment and systems (imaging and non-imaging) as necessary. Obtains parts ordering information and provides ordering requests to the Supervisory BMET for approval Documents all work completed per Biomedical Engineering?s standard operating procedure Accomplishes work in a timely manner within an established framework of policies/guidelines, and regularly reports equipment and job statuses to the Supervisory BMET. Works closely with other Engineering and clinical personnel in solving unique medical systems problems. Technician is expected to communicate effectively with these personnel to determine the objectives desired, while conceptualizing, suggesting, and working out solutions to the problems or situations. Customer service ? Daily work shall be customer-oriented. Provides services to medical center staff, patients, visitors and the general public, which are consistently courteous, cooperative and responsive to the needs of our customers. EQUIPMENT SUPPORTED : General imaging equipment such as radiographic/DR rooms, rad/fluoro rooms, CR units, mammography, dental x-ray, mobile x-ray and c-arms, and diagnostic ultrasound, as well as some general medical equipment. Specific equipment includes, but is not limited to: GE AMX4 portable x-ray GE/OEC c-arms Philips Diagnost Eleva R/F rooms Kodak DR9000 DR room Philips Digital Diagnost DR room GE Definium DR room Toshiba Kalare R/F room Hologic bone densitometer GE Senograph Mammography unit Diagnostic Ultrasounds - Siemens Sequoia, Philips IU22, IE33, GE Vivid E9 Kodak/Carestream CR950/CR825 CR units Planmeca dental x-ray units EDUCATION/EXPERIENCE : Associates degree or higher, or equivalent (e.g., military training), as an electronics technician and/or BMET Basic imaging equipment training (i.e., Phase I, II, III) Minimum of three (3) years experience performing imaging equipment maintenance PHYSICAL DEMANDS : Work assignments involve bench and on-site repairs requiring sitting, standing, walking, lifting, climbing, bending, and working in cramped and awkward positions. Incumbent frequently handles objects weighing up to 40 pounds and occasionally objects weighing in excess of 40 pounds. WORK ENVIRONMENT : Maintenance shop and patient care areas. Work is primarily done inside well-lighted, heated and ventilated areas, although access to some equipment may be more cramped and not as well lit. May be exposed to tremendously high electrical voltages and currents, and may sustain cuts, bruises or burns caused by electric shock, hot components, and ionizing radiation x-rays. May be exposed to patient bodily fluids when working in patient-care areas. QUALITY ASSURANCE SURVEILLANCE PLAN (QASP) : The temporary staff member?s performance will be monitored regularly by the Supervisory Biomedical Engineering Technician (BMET). Completed assignments will be reviewed/discussed with the Supervisory BMET. Incomplete/pending work orders and preventive maintenance (PM) assignments will be reviewed on a regular basis, generally weekly but more frequent if needed, to ensure work is being completed in accordance with contract requirements. COMPANY PROFILE MSS Services, Inc. is a SBA Certified 8(a) Small Disadvantaged Business consisting of highly skilled professionals who specialize in the management, administration, engineering, construction management, operation and maintenance of client facilities. We deploy the talents of our staff either individually or in a team format at the client facility in support of a specific need or range of needs as they are defined by the client's scope of work. Some examples include deployment of supplemental professional talent (i.e. Project Managers, Construction Managers, Engineers, Architects, Biomedical Engineers and Technicians, Project Controls Specialists, Contracts Specialist) to provide day-to-day care and oversight of building systems and to achieve the specified scope of work activities. http://www.mssserv.com/...

Biomedical Engineer - Equipment Repair

ESTABLISHED BIOMEDICAL EQUIPMENT SERVICE COMPANY SEEKS PM AND SERVICE PERSONNEL TO MAINTAIN AND REPAIR MEDICAL EQUIPMENT IN HOSPITALS, NURSING HOMES, CLINICS AND OTHER HEALTHCARE FACILITIES. OPPORTUNITY (AFTER TRAINING) TO REPAIR HIGH TECH EQUIPMENT SUCH AS PHARMACY PACKAGING SYSTEMS, SCRUB SUIT DISPENESERS, UV DISINFECTANT MACHINES, DNA TESTING LABORATORY EQUIPMENT, ULTRASOUND EQUIPMENT, CARDIAC CATH LAB EQUIPMENT AND ROUTINE EQUIPMENT TYPICALLY USED IN NURSING HOMES AND CLINICS. Experienced Biomedical Technicians: should have medical equipment background. Will consider military or technical school graduate with a degree in electronics and related experience. Biomedical Field Service Technicians needed to perform inspections, preventive maintenance and repair medical equipment for health care facilities in the Greater New York Metropolitan area. We are a growing, Independent Service Organization (ISO) specializing in Nursing Homes, Hospitals, Clinics, Physician and Physical Therapy Practices. Applicants should have a career (long term) objective to grow with the company. A BMET certification is a plus....

Biomedical Information Systems Engineer

Under direct supervision, this position assists in monitoring and controlling server health in a biomedical information system environment. This position requires a basic knowledge of personal computer and server processes and operations. The Systems Engineer will interact with the Information Technology and Clinical Engineering staff, and biomedical equipment vendors to ensure the health and performance of servers and personal computers that cannot be modified or monitored by the IT department. This person is competent to work on entry level phases of server operations, but still needs instruction and guidance for more advanced duties. Provide process improvement to strategically align medical devices on the network with IT governance such as HIPAA, and HITRUST. Proactive liaison between Clinical Engineering and IT to provide better communication and resolution of issues. Ensure basic configurations and protections are in place on all biomedical information systems to ensure ongoing health and operations of computing equipment. Interact with IT, CE and biomedical equipment vendors to ensure timely installation and maintenance of Centura Health?s biomedical information systems. Perform regular checkups and monitor logs to ensure errors, events and capacity issues are remediated. Works with biomedical equipment manufacturers to ensure critical patches to both operating system and application software are applied in a timely manner. Address cyber security issues found in medical devices Maintains documentation to assist with tracking health and performance of biomedical information systems. Monitors permissions and access to patient information to ensure privacy....

Biomedical Technician

PMG , the premier industrial contracting company, has multiple, nationwide openings for Biomedical Technicians with experience installing, troubleshooting, repairing and maintaining medical equipment to include Imaging, Systems Integration, Instrumentation and Laboratory Equipment. These are temporary opportunities that are available immediately for all qualified Biomedical Technicians. We work with Fortune 500 Clients across the US throughout the healthcare and hospitality industry. PMG's Biomedical Technicians receive $28.00/hour and are guaranteed 60 hours of work each week. With a daily per Diem of $45.00, we guarantee you at minimum, $2275.00/week! This position will require travel. However, we pay for your travel (mileage reimbursement or flight paid) as well as your lodging. Interested candidates should send their resume to...

Biomedical Repair Technician II

Job Description: BMET II - CORPUS CHRISTI We are looking for a Biomedical Repair Technician II for our account in Corpus Christi, TX. In this position you will be responsible for providing service and repairs on general biomedical equipment on site at a hospital, including preventive maintenance, and calibrations. Responsibilities: Perform complex repairs and calibration services on a broad range of patient care and support equipment. Perform planned maintenance and electrical safety inspections on range of patient care and selected support equipment in compliance with established standards. Manage equipment and schedule service. Perform pre-acceptance inspections and develop PM procedures on newly purchased equipment; maintain files on procedures and manuals. Ensure test equipment is working properly and calibrated within established intervals. Research and initiate orders for repair parts. Provide informal training to equipment users. Participate in the Quality Improvement/Risk Management program and make recommendations for improvement. Provide emergency on-call responsibilities as needed....

Biomedical Design Engineer / CAD Designer ? Yonkers, New York

Are you looking toutilize your expertise CAD Design to advance your career? Our industryleading client in the Biomedical / Medical Device industry is seeking acreative Mechanical Hardware and Equipment CAD Design Engineer. I am absolutely passionate about thisclient and believe that this company and team have an unlimited ceiling. I would love to have the opportunity tospeak with you and share my excitement about their future. The CAD DesignEngineer is responsible for the creation, design, and manufacturing ofproduction processes and devices for a growing organization with anaward-winning leadership team. This company is looking for individuals withsignificant growth potential as expansion and growth are a part of theirimmediate future. This role functions as both a Project Manager and aroll-up-the-sleeves CAD Designer. Ifyou thrive when every day and each project look different than the onebefore, enjoy a fast paced entrepreneurial setting, and want to work for acompany where you will have access and influence with top level executivesand decision makers then this may be the career move for you. Responsibilitiesinclude: Act in the capacity of a mechanical hardware designer in support of early stage research and prototype development using CAD software Act in the capacity of a CNC programmer in support of simple to complex parts used in early stage research and prototype development using CAM software Address simple and complex issues in the manufacturing step to provide input to the design team on appropriate machining techniques to be used Assist in Computer Aided Design and Drafting with specific emphasis on parametric solid modeling, engineering assemblies etc Assist in the generation of new ideas and concepts for the utilization of various technologies for solving scientific challenges in various applications...

Biomedical Electronics Technician

Job is located in Sharon, PA. The BiomedicalElectronics Technician manages work order control, PM schedulesand generation; parts purchase request and equipment history records. Assists with staff training, policy andprocedures, regulatory compliance and software data management. Establishes and maintains supportingtechnical literature, such as manufacturer?s literature, references standards,specifications and other documents necessary for supporting the BiomedicalProgram. Performs preventive maintenance,safety test, incoming inspection, installation, troubleshooting, repair,calibration, for all patient care equipment. Serves as an advisor to an appropriate hospital committee. Demonstrates cost-effective decision makingskills. Performs all other dutiesassigned....

Biomedical Electronics Tech TEMP

In accordance with the mission and philosophy of Dignity Health, the Biomedical Electronics Technician is a professional electronics technician who provides the skills and knowledge necessary to achieve the operational goals of the Biomedical Engineering Department and Sequoia Hospital. The Biomedical Electronics Technician provides a variety of technical equipment maintenance skills including preventive maintenance and repair of diagnostic and therapeutic medical equipment and equipment systems. .A. S. Degree in Biomedical Electronics Technology, electronic technology or the equivalent with four years experience in Biomedical Engineering or completion of vocational/technical training school with four years experience in Biomedical engineering is required. A.A.M.I. certification is preferred. Valid California Drivers License. Sequoia Hospital, a Dignity Health Member, is an accredited, not-for-profit community hospital providing innovative and exceptional health care for generations of Bay Area residents. In 2014, the hospital will celebrate the opening of a rebuilt, state-of-the-art medical campus, including modernized emergency services and an all-new pavilion with three floors of larger, private patient rooms. Recognized for superior and sustained clinical quality, the hospital received the 2013 America's 50 Best Hospitals Award‚ and the 2013 Distinguished Hospital Award for Clinical Excellence‚ from HealthGrades®, a leading provider of comprehensive information about physicians and hospitals. Sequoia's Heart and Vascular Institute is a nationally known pioneer in advanced cardiac care....

Biomedical Engineer & Research Scientist

sought by Florida Hospital in Orlando, FL. Process patient clinical neuro-imaging data, integration of results from different modalities; present neuro-imaging integration results to epileptologists & neurosurgeons for clinical review; dvlp new methods of imaging data analysis & visualization to aid epileptologists in identification of potential areas of epileptic focus. Perform co-registration of post-operative CT w/ MRI & 3-dimensioanl reconstruction of EEG grids on patient brain & precisely localize seizure onset zone; outline w/ clinicians resective brain area in prep'n for surgery. Doc test results, 3D reconstruction views & resection to assist w/ patient post-operative progress & outcome. Prep IRB protocols & dvlp methods to implmt research dsgn w/ necessary h/ware & s/ware. Review technicality of products for compatibility w/ current medical eqpmt & recommendation of eqpmt acquisition for research purposes. Assist w/ faculty members' research projects & supports staff w/ tech'l issues. Participate in dvlpmt of fMRI prgm & regular operation in Brain Functional Mapping Laboratory & MEG Center. Perform advance signal analysis of intracranial EEG & MEG recordings for clinical diagnosis & research, & Initiate new research projects & produce research results in form of publication or presentation each year. Ph.D in Biomedical Engg. Ability to analyze quantitative data from multiple neuro modalities (MRI, fMRI, CT, PET, EEG, MEG). High level of comp expertise & knowl of electromagnetic field theory. Product dvlpmt & mgmt exp in a research lab or industrial setting. In-depth knowl of biomedical engg, biomedical signal processing, comp prgrmg, & statistical analysis. Ability to dsgn & implmt research projects. Interact w/ clinical & research faculty to determine how to further dvlp, optimize, & test eqpmt. Expertise w/ general engg principals & applicable tech'l skills, implmtns & methodologies. Expertise in various essential s/ware packages incl Matlab, SPM, Persist, Curry, BESA, Analyze Direct for clinical & research purpose. Mail resume to Saji John, 711 E. Altamonte Dr. 4th Flr, Altamonte Springs, FL 32701. Source - Orlando Sentinel...

Biomedical Equipment Technician

. We are currently looking for Biomedical Technicians for a 3-4month contract in Boston supporting one of the premier Hospitals in the area. Ideal candidate would have the flexibility to start within the next 2 weeks. This is a first shift position (M-F), please email your resume to Todd.Schecter@AdeccoNA.com for review. Responsibilities: Install, calibrate, repair and inspect medical equipment and solves moderately complex problems in the field. Perform repairs up to and including the diagnosis and repair of difficult technical problems. Participates in evaluations and installations of equipment. Experience with medical equipment and medical devices (electronic, mechanical and computer-based technologies) for use in clinical or research applications and/or clinical facilities systems, such as sterilizers, water systems, warmers, operating room tables, and surgical lights. Inspects newly acquired medical devices and systems for safety and function and attaches and assigns appropriate control numbers and labels to medical devices. Perform preventive/scheduled maintenance on medical devices as required. Perform equipment repairs of substantial difficulty to a level requiring generic test instrumentation or diagnostic software, e.g., to board level for electrical devices. QUALIFICATIONS: AS in Biomedical Equipment Technology or equivalent level of education or experience. 2 years of experience with Bio-medical equipment, documentation, compliance Experience in repair of mechanical, electro-mechanical, electronic, and/or computer medical technology to sufficiently diagnose and repair medical devices and systems. ? Ability to perform testing and troubleshooting of medical devices involving specialized and generic test equipment and software diagnostic tools....

Senior Design Quality - Mechanical or Biomedical Engineer

Location: New England Region Job Title: Senior Design Quality - Mechanical or Biomedical Engineers Start Date: 1 week Our client ranks among the world's leading medical device companies, focusing on technologies for the treatment of coronary and vascular disease, chest trauma, hernia and soft tissue injury. Job Opportunity: We are looking for experienced Senior Design Quality - Mechanical or Biomedical Engineers to join RCM's on-site project team to support ongoing projects. The main skills are: Experience with Design controls and Design V&V Experience with Process validation and Risk management in Medical device industry Experience with design control of mechanical devices; Experience with PTFE, stent delivery or balloon catheters a plus Education: Minimum 4 year degree preferably Mechanical or Biomedical Engineering This is a contract to perm position. About RCM: http://www.rcmt.com/Industries/Life-Sciences.aspx RCM is a recognized national leader in IT and regulatory compliance services providing a broad range of consulting and management services to pharmaceutical, biotech and medical device manufacturers. The unique combination of our IT, Regulatory, and Engineering Practices brings an unparalleled breadth of knowledge and experience to our clients. RCM maintains a dedicated Life Sciences Practice that consistently reevaluates the market to determine areas of improvement. Our practice leaders constantly challenge ourselves to bring 'true savings whether through cost reduction or by reducing a products time to market. We look forward to hearing from you!...

Biomedical Engineer ? X-Ray/Imaging

About Soma Technology, Inc. : For over 20 years Soma Technology, Inc. ( www.somatechnology.com ), headquartered in Bloomfield, CT, has been a market leader in outfitting healthcare facilities with high-quality new and refurbished medical equipment. Soma?s position of leadership in the biomedical and imaging equipment industry and commitment to customer satisfaction has led to growth every year since 1992. Soma is a fast-paced, upbeat workplace housing all departments in one location. Due to growth and expansion, Soma Technology has one opening for a biomedical engineer in the Imaging department to work in its Bloomfield location to inspect, calibrate, repair and refurbish x-ray imaging equipment to OEM specifications. Job Description: Analyze diagnostic imaging equipment (x-ray, c-arm, portable x-ray) and subassemblies to determine compliance to OEM specifications Proficiently use test equipment to complete evaluations Identify corrective action necessary to repair equipment Answer technical questions from internal staff and customers Document test results and equipment performance history Research technical issues using all available data Identify parts required to repair equipment and correct problems Certify equipment has been refurbished to OEM specifications Talk with customers to troubleshoot problems Perform final inspection of equipment before shipment Comply with all applicable standards, policies and procedures including safety and clean work area maintenance Travel to onsite evaluations to determine repair or oversee installation...

Biomedical Engineer

Looking for resources to help evaluate complaints for a medical device company and write Medical device reports - preferred Bio-medical Engineers or Nursing Degree. POSITION RESPONSIBILITIES: *Evaluate incoming field reports, product returns and product analysis results for Neuro products to determine: Medical Device Reporting (MDR) eligibility and perform investigation activities. *Investigate specific events by contacting internal resources, Medtronic field personnel and/or physicians/customers as appropriate. *Initiate and complete MedWatch reports for timely submission to the FDA. *Maintain awareness of new products, government regulations and requirements. *Develop and maintain integrated system post market safety reports for both drugs and devices. *Provide input on internal system and methods to maintain MDR/ADR compliance and support post-market surveillance. *Ensure personal understanding of all quality policy/system items that are personally applicable. Follow all work/quality procedures to ensure quality system compliance and high quality work. The candidate should have an engineering degree with 0-5 years work experience in complaint handling. Be willing to work with high volumes of complaints. Ability to support data analysis and design changes (both electrical and mechanical) under the direction of the lead engineer would be ideal. About Aerotek: Aerotek, headquartered in Hanover, Md., is a leading provider of technical, professional and industrial staffing services. Established in 1983, Aerotek is an operating company of Allegis Group, the largest provider of staffing services in the U.S. Aerotek operates a network of more than 200 non-franchised offices throughout the U.S., Canada and Europe. For more information, visit Aerotek.com ....

Process Safety Engineer

About DSM DSM Biomedical is a market leader in regenerative medicine and in the supply of biomaterials for medical devices. We have established a team of exceptionally talented and experienced individuals who are committed to innovation, collaboration and improving the medical professional and patient experiences. Our company possesses expertise in the research, development, scale-up and supply of novel materials and medical devices. This market is growing at a double digit rate and is characterized by long term commitment. Intellectual property is of paramount importance in this high value added market arena. DSM Biomedical is organized in several business units around a combination of technological platforms. These business units are regionally anchored and serve a global customer base. DSM Biomedical is part of the DSM Innovation Center and provides a proprietary product portfolio with coatings, drug delivery platforms and a wide range of biomedical materials that enable the replacement, repair, enhancement and the regeneration of tissue and organ functions in the body. Its novel materials-based solutions are designed to meet the needs of the medical device and pharmaceutical industries. The ultimate objective is to improve the outcome for patients. DSM?s medical device expertise spans one of the broadest portfolios of medical materials, including biostable polyurethanes, ultra high molecular weight polyethylene?s, resorbable polymers, ceramics, collagens, extracellular matrices, silicone hydrogels, device coatings, and drug delivery platforms. Millions of products are produced each year for applications in orthopedics, sports medicine, ophthalmology, general surgery and cardiology. The Position Reporting to the Senior Manager, Improve Plant, the Process Safety Engineer interacts with R&D, Safety, Health & Environment (SHE), Facilities Maintenance, and Operational Personnel. This position interacts into the wider DSM Corporate world and other DSM businesses to leverage learning, assist in complying with DSM SHE and Manufacturing Requirements. The mind set for this position will promote a continuous improvement approach to safety, health, environment, and quality. The position requires the ability to assess complex chemical and polymer manufacturing processes and equipment for potential risks, develop mitigation plans, and implement required changes in accordance with all company requirements in an expeditious manner. The ability to prioritize actions based on risk assessment is critical. The Process Safety Engineer reviews all new proposed processes, process equipment, proposed changes to processes or process equipment, and exiting plant operations to determine all necessary SHE requirements are addressed in a thorough and rigorous manner. Regular assessments of process safety procedures, related equipment, training of operators, and other SHE related items are also within scope. Key Areas of Accountability / Responsibility: Conduct Process Hazard Analysis (PHA) studies for applicable processes. Utilize Risk Assessment techniques as needed to develop PHA recommendations and track to completion. Assist area personnel with Management of Change (MOC) core team hazard assessments and documentation. May lead investigations of site process safety incidents, utilizing root cause analysis concepts and developing appropriate corrective actions. Proficient in TRIPOD investigation procedures. Writes related reports and summaries. Work with area Operations and R&D to provide process safety support. Daily interaction with area engineers, process specialists and process leaders. Provides technical expertise to all departments to help evaluate risks and cost-effectively resolve process safety (Property Protection) issues, including recommendations from PHAs, audits and incident investigations. Writes specifications for new equipment required to ensure safe operation of manufacturing processes. Writes SOPS and trains operating personnel on proper use of said equipment. Prepare documentation to provide sufficient information for Project Engineering for detailed specifications for cost estimates and construction. Investigate and implement continuous improvement processes required to improve Safety in manufacturing operations. Establish network with other DSM business? to learn, assess and adopt best practices with respect to operational safety. Participation in or presentations at PMP phase transfer meetings in the capacity of addressing SHE risks and mitigation plans....

Manager of Clinical Engineering

TMC is seeking a senior level manager to oversee all clinical equipment services at TMC. The successful candidate will have at least 7-10 years? experience in the biomedical field and at least 5 years? experience in medical equipment management. TMC is a leader in medical equipment technology integration and we?re seeking someone who can take this program to the next level through leadership, collaboration and positive partnering with clinical leadership. Experience with a wide variety of biomedical and medical equipment including pumps, monitors, ventilators as well as diagnostic imaging devices is key to this role. Experience managing medical equipment in a Joint Commission certified hospital is also desired. If you want to join a leader in healthcare and healthcare IT, please consider applying for this position today. This position reports to the IS Director ? Infrastructure & Operations....

Medical Device Design Engineer / R&D Engineer

Engineer Today, Manager Tomorrow *** Positions in Harrisburg and King of Prussia, PA **** A very good client of ours is searching for several Product Development Engineers. Candidates ranging from Junior to Principal levels should apply. This is with a pioneering medical device company. The ideal candidates will have a background in Mechanical Engineering. This is a ?hands on? position that involves ?concept to manufacturing? work. Mechanical Engineers with the innovation and work ethic have an excellent chance for advancement as the company continues to expand. Please do not hesitate to apply. - BS, MS, PhD ? Mechanical Engineer or Biomedical Engineer - 2 -10 years of medical device experience - Concept to Manufacturing - Innovative, fast moving company - SolidWorks, FEA, GD&T, Fluid Dynamics...

Field Service Engineer Anesthesia Specialist -

Organizational Overview Founded in Denver in 1967, HSS has grown to become America?s leading sourcing company, providing technical and professional service programs to customers nationwide. We customize our service programs to each customer?s needs, culture, and desired outcomes. HSS works closely with customers to enhance the value of their business. We offer smarter solutions, become integral members of their team, and devote ourselves to creating great customer experiences. This business approach has earned HSS one of the highest customer retention rates in the industry. Our commitment to good employee communication, fair wages and benefits, and career advancement opportunity through education and training, also gives us one of the highest employee retention rates in the industry. We offer specialized expertise to customers in select markets. HSS services include healthcare/hospital security, aviation/airport security, government security, biomedical equipment management, security systems integration, and temporary healthcare staffing. Position Summary: The goal of the Field Service Engineer is to provide excellent equipment repair and customer support for HSS customers and their mission. This position completes repair service work, and preventative maintenance on equipment in accordance with established HSS policies and procedures. Works with a high degree of autonomy and provides a high level of customer service. The HSS Medical Equipment Management (MEM) team supports numerous nationally & internationally renowned health care facilities. Our MEM Field Service Engineers demonstrate our 8 Pillars of Success in all of their customer interactions. Those pillars are: Service, Image, Reward, Advocacy, Training, Team, Benefits, and Advancement. Essential Duties and Responsibilities: ¨ ?Performs service work and maintenance of medical equipment and ensures completion of the percentage requested by manager. ?Resolves issues pertaining to the medical equipment and works with other shop staff to ensure equipment and technology is working within specifications. ?Accurately documents and keeps detailed records of all work related activities as specified by manager. ?Performs scheduled inspections and testing as asked. ?Provides support of the equipment repair process such as following up on customer questions, attending meetings, support of field service engineers, and research issues. ?Perform repetitive job tasks required in the servicing and remanufacturing of equipment. ?Provides all other support as requested by manager. ?Cleaning and preparing parts and assemblies for replacement. ?Works and interacts with current and prospective clients, other employees, sales representatives, vendors, medical personnel, guests, and visitors. ?Work with equipment to meet regulatory requirements. ?Teach and train personnel on the steps and process of repair, maintenance ?Oversee and qualify work of other shop employees as required by the manager ?Other duties as assigned....

Clinical Engineering Manager

SENIORCLINICAL ENGINEERING MANAGER ? BIOMEDICAL Our client isa leader in the healthcare industry and has been listed as one of the MostAdmired Companies by employees. Currently they have a great opportunity in Chicago for a Senior ClinicalEngineering Manager. This individualwill be responsible for strategic operations of the Clinical EngineeringDepartment within a medium to large hospital environment. Oversee the hiring, training, and placement of staff within the department Implements Human Resources policies and procedures Ensures compliance with OSHA, Joint Commission/DNV regulations in addition to federal, state, and local. Manages departmental budget Maintains constant communication with client(s) regarding performance and proactively works to improve processes as it relates to the department and cost Provides counsel with client regarding capital equipment acquisitions/purchases Instrumental in promoting team development and retention of employees...

Engineering Manager (IRC7561)

This position is responsible for the management of direct reports to execute and deliver in a timely manner identified projects into commercial products, identification and development of new product development opportunities and serving as a technical leader in Regenerative Technologies. ? Serve as a technical leader for the execution of new product development in the Biomaterials Regenerative Technologies arena encompassing our reconstructive, orthopedic and soft tissue platforms. ? Effectively manage the daily activities of a diverse group of technical and non-technical staff, both through direct and non-direct reporting relationships, from conceptual development through commercialization of new products. ? Lead the identification and assessment of relevant technologies and product opportunities, and translate the opportunities into viable business assessments and development projects. ? Provide chemical, mechanical, and biomedical engineering design principles, development and manufacturing expertise to the development of regenerative medical devices in accordance with the Integra Product Development Process and Design Control requirements. ? Regularly attend and witness surgical labs and procedures in our product development efforts. ? Develop and maintain effective cross-functional working relationships with Marketing, Sales, Regulatory, Clinical Affairs, Manufacturing Operations, Quality and Finance peers to effectively execute R&D and Product Development efforts. ? Mentor and develop technical personnel in all aspects of R&D and Product Development; provide continuous performance feedback, and as requested input to performance planning, assessment and review activities for junior technical personnel. ? Effectively implement problem solving skills and techniques to identify real and potential issues, assess the impact, develop and implement mitigation and resolution plans. ? Employ excellent interpersonal, communication and negotiation skills with all levels of personnel and management to facilitate information flow between team members and senior management. ? Ability to create solutions by thinking ?outside the box?. ? Preference will be given to those with appropriate experience in the areas of collagen chemistry, processing and medical devices....

Mechanical Engineer

TriMech Services is an engineeringresource provider specializing in supporting our clients? needs both fortemporary engineering as well as direct hire situations. TriMech Servicesoffers a unique and specialized approach to supporting our client?s engineeringrequirements which allows us to customize solutions that enable our clients tobe more successful, save time, and operate more efficiently. Mechanical Engineer Responsibilities: Creates CAD model and engineering drawing fromprototypes Revises design and engineering document by submittingDCO Plans and implements design verification andvalidation testing Conducts process validation plan Creates and revises DFMEA Maintains Design History Files Provides task status and progress Qualification A Bachelor?s degree in mechanical engineering orbiomedical engineering or other Engineering discipline is requiredwith a minimum of 2 years ofrelated experience Demonstrated understanding of various types ofmanufacturing, materials, drafting standards. and GD&T arerequired Basic knowledge about quality assurancestandards Experience with 3D design Good verbal and written communication skills...

Robert S. Langer Family & Friends Professorship

Robert S. Langer Family and Friends Professorship Department of Biomedical Engineering Cornell University Cornell is a community of scholars, known for intellectual rigor and engaged in deep and broad research, teaching tomorrow?s thought leaders to think otherwise, care for others, and create and disseminate knowledge with a public purpose. The Department of Biomedical Engineering at Cornell University invites applications for the Robert S. Langer Family and Friends Professorship. The department seeks exceptional candidates who will dramatically enhance research and teaching in the department, develop synergies with current areas of departmental strength, and embrace the department?s vision of a quantitative, multi-scale approach to applying engineering solutions to problems in human health. Candidates are expected to currently have an internationally recognized program of research and teaching in biomedical engineering. The department has five areas of research emphasis: biomaterials and drug delivery; biomedical mechanics; nanobiotechnology; imaging and instrumentation; and cellular and tissue engineering. Exceptional candidates who add to or complement these areas will be given serious consideration. Considerable institutional resources are available for the support of the successful applicant?s research program and a competitive start-up package can be expected. Cornell BME acts as an intellectual bridge between engineering and physical sciences and the biological and medical sciences. It values interdisciplinary projects and actively promotes interactions with the Weill Cornell Medical College, the College of Veterinary Medicine, and basic engineering and biological sciences. Cornell hosts numerous centers, including the Physical Sciences-Oncology Center on the Microenvironment and Metastasis, the Weill Institute for Cell and Molecular Biology, the Nanobiotechnology Center, the Cornell Nanofabrication Facility, and the Cornell Center for Materials Research. BME and the College of Engineering at Cornell embrace diversity and seek candidates who will create a climate that attracts students, staff and faculty of all races, nationalities and genders. We strongly encourage women and underrepresented minorities to apply. Cornell University seeks to meet the needs of dual career couples, has a Dual Career program, and is a member of the Upstate New York Higher Education Recruitment Consortium to assist with dual career searches. Visit http://www.unyherc.org/home/index.cfm?site_id=671 to see positions available in higher education in the upstate New York area. Applicants should submit a curriculum vitae and complete contact information for at least three references. Submit applications electronically to: https://academicjobsonline.org/ajo/jobs/4890 Questions may be sent to: , Larry Bonassar, Chair, Search Committee, 607-255-9381 . Applications will be accepted until the position is filled. Cornell University is an innovative Ivy League university and a great place to work. Our inclusive community of scholars, students and staff impart an uncommon sense of larger purpose and contribute creative ideas to further the university's mission of teaching, discovery and engagement. Located in Ithaca, NY, Cornell's far-flung global presence includes the medical college's campuses on the Upper East Side of Manhattan and in Doha, Qatar, as well as the new CornellNYC Tech campus to be built on Roosevelt Island in the heart of New York City. Diversity and Inclusion are a part of Cornell University's heritage. We're an employer and educator recognized for valuing AA/EEO, Protected Veterans, and Individuals with Disabilities. PI86403457...

Field Service Engineer III - Bay Area

The Field Service Engineer III (FSE) is responsible for the overall service and repair of Olympus instrumentation within an assigned geographical area or other areas as required developing skills and/or providing timely customer support utilizing a high level of product based service proficiency of Olympus or directly related equipment and instrumentation dealing with advanced imaging and optics systems. Requirements...

Software Engineer ? Software Developer ? Web Developer

Software Engineer ? Software Developer ? Web Developer About Our Company: We at Prometheus have built our reputations on helping diverse members of the biomedical research community overcome the ordinary and extraordinary challenges of managing data. We provide outsourced data management services and expert consulting, and deliver sensible solutions to data management problems powered by our adaptable, web-based RexDB platform. We enjoy the privilege of working with smart, passionate clients. See to read what they think of us. We got our start at Yale, and are now trusted by institutions across North America. We value integrity, curiosity, and determination. We pride ourselves on engaging in work that is meaningful, and we enjoy collaborating with others who view their work as an opportunity to make the world a better, smarter place. Our environment is open, informal, and agile. We are dedicated to learning and to professional growth, and we consistently look for opportunities to increase responsibilities to match abilities. What could be more cool than building open-source tools for open science? Nothing. Use your experience as a software developer to make the world a better, smarter place by creating tools that amplify the value of scientific data and then releasing these tools to the open source community so that any researcher can use them to accelerate scientific discovery. Use efficient technologies like Python and HTSQL and modern agile development practices. Work with smart, decent people deeply engaged in their work. Help an exciting small company grow to its potential. At our headquarters in New Haven, Connecticut, we create data management solutions for leaders in the biomedical research community, ranging from front-line scientists to the institutions that fund them. We deliver and support these solutions via our novel application development platform, which blends the innovative (HTSQL + REACT forms) with the established (HTML + CSS + JS). We need you to help us customize our solutions with intuitive UIs that support elegant workflows and data interactions, and to help us develop impressive new JS-based components for our platform. Daily activities include: Plan, document, build and test JS-based and REACT enhanced components for our template-driven web application Work with business process analysts to refine user requirements and translate them into a technical plan Participate in design discussions about overall functionality and architecture Work with managers and team members to estimate delivery times and set priorities Report on progress to relevant stakeholders Assist with delivery of semi-custom applications to customers, which may involve developing prototype functionality not yet available in the main product trunk...

Associate (Jr) Mechanical Engineer

Keystone Computer Solutions has a twenty seven year history of providing superior service and focused commitment to our clients, strategic partners, and the community. Trust in service delivery and adherence to best practices has made us a premiere collaborative solutions provider in the Twin Cities and a well-respected corporate citizen. KCS was initially formed to provide a framework for individual technology contractors to market their services to IT organizations. Today KCS continues to successfully serve our candidates and clients by matching them up with the right opportunities. We are currently looking for an Associate (Jr.) Mechanical Engineer for a client of mine in Jacksonville, FL area and would love to hear from you if you meet the following criteria. Associate (Jr.) Mechanical Engineer Medical Device **6 Month Contract** Associate (Jr.) Mechanical Engineer REQUIRED QUALIFICATIONS : *Bachelors in mechanical, electrical or biomedical engineering *0-2 years experience with a Bachelor???s degree (New graduates considered) *Must be able to use and apply technical principles, theories, concepts and techniques *Provide solutions to routine technical problems of limited scope and complexity *Work and communicate effectively with other engineers, designers, surgeons, marketers and suppliers to develop products from concept through commercialization in a cross-functional team *Must have effective communication and presentation skills *Be able to handle multiple tasks/projects and manage priorities accordingly *Be flexible in a changing professional environment, and have good knowledge of Microsoft Office applications. MAIN PURPOSE OF JOB : *The person in this roll designs, develops, analyzes, troubleshoots and provides technical skills during research and/or product development, uses multidisciplinary engineering knowledge to design and develop medical devices or components / subsystems in support of strategic plans. *This position supports the ideation, development, design, implementation, test and transfer to manufacturing of ENT and NT devices. MAIN JOB DUTIES: *Assists in developing new and improved biomedical products used during ENT and NT procedures / surgeries; and the related manufacturing processes for those products *Develop prototypes, verification/validation units and product specifications, including material specifications, assembly drawings and manufacturing documentation. *Perform verification testing and coordinate/support validation testing activities *Provide sustaining engineering support for existing products *Create Intellectual Property (IP) through idea and product submissions and patent applications *Travel to observe surgeries, attend sponsored meetings and meet with suppliers. Associate (Jr.) Mechanical Engineer Medical Device...

Testing and Reliability Engineer - Cook Inc.

Medical Product Manufacturing Since 1963, Cook Group companies have been among the leaders in developing healthcare devices that have improved lives around the world. COOK remains at the forefront of medical research and worldwide sales of products for endovascular therapy, critical care medicine, general surgery, diagnostic and interventional procedures, bioengineered tissue replacement and regeneration, gastroenterology and endoscopy procedures, urology, and obstetrics and gynecology. COOK is a global company with a global focus - and a global future. Job Functions/Duties (may include other duties as assigned) The Testing and Reliability Engineer will plan, research, develop, evaluate, validate, implement, and document laboratory test requirements, procedures, equipment, and methods in support of product development and other regulatory, laboratory accreditation, and engineering projects. He or she will: Write detailed protocols for various studies in support of worldwide regulatory submissions supervise technicians in the performance of scientific studies Oversee testing Provide input and participate in discussion on product improvement, testing & designs Develop procedures and documentation needed to obtain laboratory accreditation Drive and complete additional projects above and beyond testing in a collaborative environment find solutions independently or in collaboration, Provide value by acting as an owner of the project or initiative Ensure testing process is adhered to Set up and maintain the test environments as needed to complete testing Job Requirements Experience must include the following: Research and publications Project management GLP regulations Mathematical and statistical methods Preparation of scientific reports Word processing, spreadsheets and graphical applications Education Requirements Bachelor's Degree in Engineering, Materials Science, Biomedical Engineering, or closely-related field and Two (2) years of practical experience with laboratory practices and methods ***Employer will also accept a Master's Degree or Ph.D. in Engineering, Materials Science, Biomedical Engineering, or closely-related field in lieu of the Bachelor's degree and two (2) years of experience requirements. Additional Requirements Must have current authorization for permanent employment in the U.S. Physical Requirements Works under general office environmental conditions. Sitting for extended periods, utilizes close visual acuity for working with computers, etc. Our Benefits Base Salary Teamwork bonus 401(k) retirement savings plan with company match Profit sharing Medical, dental, and vision Life insurance Paid time off Flexible spending account Educational assistance/reimbursement We are proud to be an equal employment opportunity employer for men, women, protected veterans and disabled individuals. We maintain a drug-free workplace and perform pre-employment substance abuse testing as permitted by law....

Sr. Engineer (Medical Device) - GMP, FDA Audit - St. Louis

We are looking to add a Senior Engineer to our Fortune 500 organization! Could YOU be that person? The Senior Engineer is a fast-paced, rewarding career opportunity that is extremely important for this company's growing operations in the greater St. Louis area! SUMMARY You will be part of a 4-5 person team working on an FDA audit project on medical devices. Team will have a 18 month deadline to become FDA compliant. Primary Job Duties Responsible for working in accordance with FDA Quality Systems Regulation, ISO 9001, ISO 13485 and other applicable country specific regulations. To work on a team of 4-5 Engineers and CAD drafters Perform root cause and failure analysis on non-conforming materials generated on the production floors and field returns Take corrective action (documentation and justification) on failures both in house and with vendors Ensures products (including services) are developed, manufactured, tested and delivered according to established procedures that will assure that they meet all quality requirements. The incumbent must be cognizant of the effects of changes to regulatory requirements (e.g., new revisions to ISO 9001, ISO 13485, country specific regulations, etc.) ensure compliance to these regulations and standards....

Development Engineer Sr. - Orthopedic

Development Engineer Sr. -Orthopedic Position: DevelopmentEngineer Sr. - Orthopedic Location:Parsippany, NJ Type:Contract Development Engineer Sr. - Orthopedic JobDescription: Responsiblefor the design, development, and processing of implants and instruments. Workis expected to encompass both the development of new products and maintenanceof existing products. Position will lead medium scope projects, multiple smallprojects or large portions of a large project as a core team member. Managementof engineering staff of equal or lower positions may be assigned. PrincipalDuties and Responsibilities * 25% -Leads the development of new products and manufacturing processes. Identifiesall tasks required to complete project assignments according to Design Controlprocedures. Prepares work plans outlining estimated manpower requirements anddevelopment costs. Recommends project budget and schedule to carry out programson a timely basis. * 20% -Designs or directs design work for manufacturability, inspectability andoptimum cost * 10% -Conducts or participates in root cause analysis for problem solving * 10% -Contributes to generation of a comprehensive protocol for testing/analyzing theproduct * 10% -Coordinating product evaluation with surgeon * 5% -Prepares definitive new product specifications or modifies existingspecifications * 5% -Generates or updates design assurance documentation for the product * 10% -Completes stress analysis on new or existing designs * 5%Generates and/or manages the creation of prototype models to evaluate newdesign concepts (This isnot an exhaustive list of duties or functions and may not necessarily compriseall of the "essential functions" for purposes of the ADA.)...

Project Engineer, Medical Device

Project Engineer, Medical Device, Summary: Our client in the Akron, Ohio, area, a spinal implant company, is in need of a Project Engineer. This position is a Direct Hire. The Project Engineer will design innovative surgical implants and instrumentation from concept to launch. Along with management and the engineering staff, the Project Engineer will be responsible for various aspects of product development including mechanical design, materials procurement, feasibility, prototype fabrication, testing, surgeon product development meetings, and product launch. Project Engineer, Medical Device Essential Job Functions: Design electro-mechanical systems that include implantable sensors, external controllers, and surgical instruments. Generate 3-D CAD models and engineering drawings using SolidWorks software. Manage project and project documentation, adhering to FDA design controls and ISO 13485 requirements. Develop implant sensor, external controller, and instrument design concepts through interactions with clinicians. Create product inspection criteria and first article verifications. Generate comprehensive testing procedures for FDA and ISO 13485 V&V testing. Perform unit and system testing for Verification and Validation efforts. Initiate and develop intellectual property. Work with Regulatory to file FDA submissions for approval. Support product launch and ongoing product maintenance. Assist Sales & Marketing with field support and training. Perform duties in compliance with the Quality System. Work closely with vendors and internal resources to keep development schedules on time and on budget. Project Engineer, Medical Device Essential Job Requirements: Bachelor of Science with a major in Mechanical, Biomedical or Biomechanical Engineering required. Master's Degree in Mechanical or Biomedical Engineering preferred. 5+ years product development experience in the orthopedic medical device field with CAD experience and design history file related documentation required. Experience with mechanical test machines and data acquisition systems. Experience with 510(k) submittal highly preferred. Proficient with SolidWorks or Pro-E software (Solidworks preferred). Proficient in MS Office Suite (Word, Excel, PowerPoint, and Project). Perform duties in compliance with applicable FDA 21 CFR Part 820 and ISO 13485. Why Kelly ® ? Kelly puts you in charge of your career, with access to cutting edge projects and technologies in industry leading organizations. Top companies throughout the world have trusted Kelly as a premier source of engineering talent and services since 1965. And engineering job seekers know Kelly as a firm with an unmatched reputation for quality, integrity and professionalism. Whether you seek the variety and flexibility of working on short term project engagements, or prefer contract-to-hire or direct hire placement with our clients, apply with Kelly to explore opportunities that suit your specific professional interests. About Kelly Services ® Kelly Services, Inc. (NASDAQ: KELYA, KELYB) is a leader in providing workforce solutions. Kelly ® offers a comprehensive array of outsourcing and consulting services as well as world-class staffing on a temporary, temporary-to-hire, and direct-hire basis. Serving clients around the globe, Kelly provided employment to more than 540,000 employees in 2013. Revenue in 2013 was $5.4 billion. Visit kellyservices.com and connect with us on Facebook , LinkedIn and Twitter . Download WorkWire ? , a free career and employment resource iPad® app by Kelly Services. iPad is a trademark of Apple Inc., registered in the U.S. and other countries. App Store is a service mark of Apple Inc....

2015 Vistakon (Jacksonville, FL) Engineering/Materials Science/Optometry Co-op/Internship Job

Johnson & Johnson companies are equal opportunity employers. 2015 Vistakon (Jacksonville, FL) Engineering/Materials Science/Optometry Co-op/Internship(Job Number: 00000SP0) Description Johnson & Johnson Vision Care, a member of Johnson & Johnson's Family of Companies, is recruiting for Operations, Quality, and Research & Development Co-op and Internships located in Jacksonville, Florida. Johnson & Johnson Vision Care, is a worldwide company with operations in the United States, Japan, Latin America, Asia-Pacific and Europe/Middle East/Africa regions. Research, innovation and new-product development are the focus of our organization. Since we introduced soft disposable contact lenses in 1988, no other manufacturer has matched the aggressive expansion of our wide-ranging ACUVUE® family of products. Our associates around the world are committed to expanding the ACUVUE® brand, and fortifying our position as the worldwide leader in the contact lens industry. Academic majors for Co-op and Internship opportunities are: Chemistry/Materials Science, Polymer Science/Chemistry, Mechanical Engineering, Injection Molding, Chemical Engineering, Electrical Engineering, Industrial Engineering, BioEngineering, Biomedical Engineering, Statistics, Optics, and Optometry. Operations Process Engineering Opportunity to work on a variety of engineering assignments utilizing a wide-range of engineering principles. Assist with planning development and design of materials, equipment, and/or processes. Review progress and evaluate results of multiple projects across various disciplines. Partner with teams of engineers and technicians as necessary to achieve project completion. Assist with facilitating and conducting engineering assignments. Advocate for continuous improvement of technology and processes. Quality Provide safe, innovative, and life-enhancing products that meet or exceed customer and regulatory requirements through a culture of customer focus, continuous improvement, collaboration, and excellence in all that we do. R&D Chemistry/Materials Science Investigate the interaction of various chemical components and their impact on finished medical devices. Project work may include formulations, photoinitiated polymerization, device processing of finished product, raw material analysis, and characterization of the finished device. Projects may involve a combination of chemical handling, blending, and device characterization. Chemistry or Material Science student is preferred. Completion of Organic Chemistry, Polymer Science, and/or Chemistry courses are preferred. R&D Mechanical Engineering Assist Senior Engineers in the planning, development and design of processes and equipment for the manufacture of contact lenses. Document all projects in the form of a technical report. SolidWorks experience is preferred. R&D Optical Engineering Collaborate on short-term Research and Development projects in the areas of Opto-Mechanical System Design and Vision Science. The projects require both laboratory and computer research as well as hands-on practical application. Interface with third party suppliers and an interdisciplinary technical team under the direction of a Sr. Mechanical Engineer. R&D Optometry Coordinate and assist with project development of clinical protocols and clinical research studies. Interpret and summarize clinical study data in technical reports. R&D Lens Prototyping Perform engineering functions supporting current and future product development projects. Generate and/or analyze data to translate/correlate lens optical and geometrical attributes to critical process parameters in lens prototyping. Create and test hypotheses based on sound engineering/scientific principles to understand and explain phenomena observed during lens prototyping and characterization. Utilize statistical analysis to design experiments (DOE) and analyze/visualize engineering data. Write SOPs/technical reports to document product and process development. Collaborate with other R&D functions to troubleshoot process/equipment in support of product development. Act as an advocate for continuous improvement of process, technology, software and hardware based on collection and translation of historical engineering knowledge to new applications/projects. Take a leading position in coordinating new as well as continuous improvement initiatives within the lens prototyping department. Qualifications Enrollment (not necessarily taking classes) in an accredited college/university during the Co-op/Internship is required. Actively pursuing at least a Bachelor's Degree in Chemistry, Materials Science, Polymer Science/Chemistry, Chemical Engineering, Mechanical Engineering, Injection Molding, Electrical Engineering, Industrial Engineering, BioEngineering, Biomedical Engineering, Statistics, Optics, Optometry, or related academic major is required. Availability to work full-time (40 hours/week) during the Co-op/Internship is required. A minimum G.P.A. of 3.0 is preferred. Demonstrated leadership and/or participation in campus/community service activities is preferred. Students must be able to provide their own transportation to this location. A stipend will be offered to students that meet the commuting distance eligibility requirements. Candidates must be legally authorized to work in the United States and not require sponsorship for employment visa status (e.g. H1-B status) now or in the future. BE VITAL in your career. Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies. Primary Location: North America-United States-Florida-Jacksonville Organization: Johnson & Johnson Vision Care, Inc. (6094) Job Function: Administration Certain sites within the Johnson & Johnson Family of Companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here. Johnson and Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status, or any other characteristic protected by law. EEO is the Law EEO is the Law GINA Supplement...

Biomed Equip Tech III B

BMET- (Biomedical Equipment Technician) certification is preferred. Candidates for this position require a combination of training, education, and experience which demonstrates a high level of proficiency in the performance of the above duties. An Associates degree in an appropriate engineering discipline required. Minimum of six years experience required Entity Main Line Services Department Biomedical Engineering Shift Weekend Requirements Salary Grade 210...

PRODUCT DEVELOPMENT ENGINEERS

Must have Med Device experience Must have metals experience Must have a Mechanical Engineering Degree or Biomedical degree Must have design experience with Pro E or Solidworks Designs and develops new implants and instrumentation. This includes communication with surgeons and sales consultants, understanding the clinical issues, defining the design parameters to support AO philosophies, and ensuring the correct product is provided to the customer. Position Duties Include: - Designs and develops new implants and instrumentation and develops improvements and modifications to current products. - Interacts with surgeons, manufacturing, regulatory affairs, sales consultants, product managers, and other functional departments to define and develop product requirements and concepts. - Works directly with surgeons for design concept development, prototype and cadaver evaluation, and clinical follow-up. - Generates product models, concept layouts, and prints using ProEngineer software. Apply geometric dimensioning and tolerancing accordingly. - Performs the required activities and generates the appropriate documents to ensure compliance with FDA Design Control regulations, and to support 510(k) submissions or IDE clinical studies. This includes all Risk Management activities - Develops mechanical test protocols according to ASTM standards and coordinates the activities required to fabricate test parts and complete mechanical testing. - Works with manufacturing during the design stages to incorporate manufacturability into the product designs. - Responsible for all the designs from concept development through product launch. - Responsible for initial patent review of designs for freedom to operate. Experience Required: - Bacheloras degree in Engineering required (BSME or Biomedical are acceptable) - Working experience with ProEngineer or Solidworks is required - Must have experience working with metals in Med Device - Experience within a product development team in the Medical Device industry is required - Familiarity with FDA Design Controls - Must have 3 to 7 yearsa experience in design and development of Medical Device products - This is a ahands ona position...

Manufacturing Engineer

Manufacturing Engineer www.vista-dental.com Vista Dental Products has an exciting, new position; as a MANUFACTURING ENGINEER to join our innovative and diverse Engineering team. Vista Dental Products is one of the largest dental manufacturers in the USA. Yet we are a smaller company based out of Racine. Hey, good things come in small packages! With a smaller more intimately based company you will be hands on from start to finish with new and existing products. This position is best suited for an individual who is looking for an opportunity to gain recognition for specific contributions while also working with a team to provide the Vista product line with continual growth and success! The ideal candidate will be a self-starter that is comfortable multitasking and able to adapt to various responsibilities. They will also exhibit the following personal traits: inventive, measurement and analysis skills, attention to detail, ownership of projects, and design skills. RESPONSIBILITIES: (include but are not limited to the following) Evaluates manufacturing processes by designing and conducting research programs; applying knowledge of product design, fabrication, assembly, tooling, and materials; conferring with equipment vendors; soliciting observations from operators. Develops manufacturing processes by studying product requirements; researching, designing, modifying, and testing manufacturing methods and equipment; conferring with equipment vendors. Improves manufacturing efficiency by analyzing and planning work flow, space requirements, and equipment layout. Assures product and process quality by designing testing methods; testing finished- product and process capabilities; establishing standards; confirming manufacturing processes; generating or updating thorough Bills of Materials (BOM?s) and manufacturing procedures. Provides manufacturing decision-making information by calculating production, labor, and material costs; reviewing production schedules; estimating future requirements. Keeps equipment operational by coordinating maintenance and repair services; following manufacturer's instructions and established procedures; requesting special service. Creating test procedures and fixtures for characterization, experimentation, and production Designing, developing, testing and modifying products, equipment and devices Writing reports and documentation Communicating and coordinating with outside vendors...

Entry Level Chemist/Chemical Engineer

Entry Level Chemist-Part-Time Kelly Scientific Resources is currently seeking entry level chemist in NW Austin for a leading environmental company. Responsibilities: Washing glassware, prepping equipment for chemist, monitoring lab supplies/inventory. Operate and maintain laboratory equipment, including systems for chemical synthesis and purification, including systems for scale-up Preparation for synthesis and/or purification operations Perform inventory counts of materials and critical equipment Support team in fulfilling low volume material orders, including material production, material packaging, and material shipping Propose and support implementation of process, hardware, safety, and quality improvements Assist in the development of operating procedures Education, Experience and Training ? Working towards a BS in Chemistry or Chemical Engineering degree ? Flexible work schedule 15-20 hour per week ? Good mechanical aptitude, knowledge of vacuum systems, mathematics involved with large scale-up and chemical synthesis. Every day, Kelly Scientific Resources connects scientific professionals with opportunities to advance their careers. To be immediately considered for this position, click the ?Apply Now!? button. Or, refer a friend by clicking the ?E-mail this job? link provided. Kelly Scientific Resources ® has grown into a $270 million global business as the scientific business unit of Kelly Services. Our staff of scientists provides scientific staffing to a broad spectrum of industries including: chemical, cosmetics, food science pharmaceutical, biomedical, consumer products, environmental, medical device, clinical, petrochemical, and clinical research. Kelly Services is an Equal Opportunity Employer. Why Kelly ® ? With Kelly, you?ll have access to some of the world?s highest-regarded scientific organizations?providing you with opportunities to work on today?s most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits you?ll be proud to help advance. We work with 99 of the Fortune 100? companies, and found opportunities for more than 11,000 scientific professionals last year. You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your career?connect with us today. About Kelly Services ® Kelly Services, Inc. (NASDAQ: KELYA, KELYB) is a leader in providing workforce solutions. Kelly ® offers a comprehensive array of outsourcing and consulting services as well as world-classstaffing on a temporary, temporary-to-hire, and direct-hire basis. Serving clients around the globe, Kelly provided employment to more than 540,000 employees in 2013. Revenue in 2013 was $5.4 billion. Visit kellyservices.com and connect with us on Facebook , LinkedIn and Twitter . Download WorkWire ? , a free career and employment resource iPad® app by Kelly Services. iPad is a trademark of Apple Inc., registered in the U.S. and other countries. App Store is a service mark of Apple Inc....

Senior Mechanical Engineer

Summary The Executive Search Firm Michael Page is working with an innovative and ground-breaking medical device design and manufacturing company in the Greater Boston Area. Seeking a talented Senior Mechanical Engineer our client is in need of someone familiar with the Medical Device field. Designing implantable and instruments this is great opportunity for anyone passionate about Medical Devices and engineering design! Client Details An established brand with a startup feel our client is paving the way to change surgeries and healthcare for generations to come. With a relaxed feel but a fast-paced environment this company is paving the way for new and better methods to tackle Less Exposure Surgery (LES). With the feel of an established start-up this unique organization focuses on its products first and foremost. With all of the hard work comes some big benefits too! Unlimited coffee and amenities and a work hard paly hard mentality. This company rewards its employees with seasonal festivities and get together events. Surrounded by people committed to their cause and technology our client offers a truly once-in-a-lifetime opportunity to join this team! Description Build 3D models and drawings for manufacture for spine, knee, and hip implants Perform engineering analysis on products, FEA and FMEA Create mechanical designs and concepts for spine, knee, and hip implants and the surgical instrumentation that goes along with them Interact with vendors and manufacturers to develop rapid prototyping Interact with surgeons, designers, and sales/marketing teams Assist in design of validation/verification testing Documentation responsibilities for Quality System procedures Profile BSME or BS in Mechanical Technology or Biomedical Engineering SolidWorks 2011 proficiency - surfacing or master modeling work preferred Proficient in SolidWorks simulation or FEA software in general Manufacturing process knowledge Use of ASME/ANSI Y14.5M, GD&T preferred Human factors and ergonomics design work Medical Device and orthopedic work preferred Job Offer Interested? Please apply now! This is an incredible company with an amazing product. Questions? Please contact Victoria LeBlanc, ....

Biomechanical Engineer

Biomechanical Engineer : We currently seek an experienced Biomechanical Engineer to support operations in our Houston office. This is an exciting opportunity for anyone seeking to branch out and explore the world of forensic consulting. Essential Job Responsibilities: Analysis of human injury resulting from vehicular accidents, mechanical failures, falls, and falling objects, as well as industrial, construction, marine, and recreational accidents. Responsibilities will include practicing vehicle accident reconstruction. Reviewing of material (e.g., photographs, witness statements, depositions, police reports, medical and chiropractic records) to provide logical conclusions. You must be able to identify and apply pertinent research literature and government regulations. Conduct field evaluations and provide oral and written reports of findings. Provide expert witness testimony via depositions or in a court of law, as needed. Travel required primarily within the South Central Region and occasionally outside the South Central United States as required to support the Company. Develop client relationships by providing and maintaining the company?s high standard of customer service excellence and proactive client communications. Work with local and national marketing managers to establish and grow relationships. Multitask to meet the scheduling commitments of multiple clients and assignments....

Technical Business Unit Manager

Job Summary Nypro is hiring a Technical Business Unit Manager who has proven success in the Healthcare Industry selling technical services including but not limited to Design, Value Add Value Engineering, Test Development, After Market Services, Complex Supply Chain Development Support, Medical Device Disposables, etc. to existing global customers and target customers. The TBUM is responsible for developing and growing business through profitable technical engagement wins and flawless execution. Assemble teams and provide management and guidance to multi-functional project teams. To be considered, candidate MUST HAVE disposable medical device R&D prior experience having directly developed disposable medical devices through to commercial launch or indirectly having a substantive role in this activity. This positions requires up to 25% travel. Essential Duties & Responsibilities Actively support sales calls involving complex technical requirements for disposable medical devices, serving as the lead ?technical engineering? resource in customer relationships. Functions as the point of contact in technical questions between Nypro and the customer. Manages and ensures the alignment and development of assigned customer?s and Nypro?s Technology road map. Assists in developing and implementing strategic direction for Nypro Product Development teams. Technical expert on customer?s and segment?s products and technology acting as an escalation point from production BU?s. Technically develops, manages and delivers highly complex technology solutions including responding to functional/technical elements of RFP?s, developing complex detailed Statements of Work (SOW), business proposals, project schedules/financials, managing multiple global projects, and design service agreements (DSA). Provide input to and support execution of account plan (LAMP), own technical strategic plan to feed LAMP. Present and sell Nypro?s Technology to assigned customer or program. Must be professional and comfortable doing presentations to external senior level engineers and management. Serves as primary point of contact for early supplier involvement on new customer R & D projects. Knows and understands the assigned Business Unit (BU)?s strategic directions. Identifies BU?s strategic and technical direction. No P&L responsibility but is responsible for AROD (Accretive Return On Design) program, quote qualification tool and similar. May perform other duties and responsibilities as assigned. Knowledge Requirements Strong understanding of enabling technologies and manufacturing technologies/processes associated with disposables. Excellent communication and presentation skills. Excellent technical skills (i.e. engineering, R & D, product design/development per assigned sector or customer) to align Nypro with customer?s technology road map Knowledge and good understanding of Nypro and Nypro site capabilities and internal/external technical service capabilities. Strong financial skill knowledge and aptitude (e.g. balance sheet and income statement) Strong operational knowledge (e.g., manufacturing, supply chain) Nypro tools (Financial system, AROD, quote process, etc.) or similar Contract knowledge fundamentals Leadership/people-management skills Strong customer service skills and experience Proficient computer skills, including word processing, spreadsheet, and presentation applications Strong project management skills Essential Skills, Abilities and Behaviors FOLLOW-UP: Able to monitor and evaluate progress of assignments / projects ORGANIZE: Able to assemble appropriate resources (people, funding, material, support) to get things done; Able to manage multiple activities simultaneously to accomplish goals; Able to schedule and coordinate work of others; Able to establish efficient work procedures to meet objectives; Able to form the right structures and teams to enhance productivity LISTEN: Able to actively listen and convey understanding of the comments and questions of others; Able to understand the situations, viewpoints and feelings of others before expressing own view PROVIDE DIRECTION: Able to establish and communicate a common vision; Able to translate company strategy into team goals and objectives; Able to set clear priorities; Able to clarify roles and responsibilities through individual performance plans; Able to make self available for questions TAKE INITIATIVE: Able to exhibit tendencies to be self-starting and not wait for signals DELIVER QUALITY RESULTS: Able to deliver top quality service to all customers (internal and external); Able to ensure all details are covered and adhere to JabilNypro?s policies; Able to strive to do things right the first time; Able to meet agreed-upon commitments or advises customer when deadlines are jeopardized; Able to define high standards for quality and evaluate products, services, and own performance against those standards COLLABORATE: Able to act as part of a larger team outside of the immediate department or group; Able to understand the importance of working with peers in other areas or management to reach "best practice" solutions for the organization; Able to inform and seek information to anticipate and consider the impact of decisions or actions on the overall organization DELIVER EXCEPTIONAL CUSTOMER SERVICE: Able to demonstrate sensitivity to customer needs (both internal and external) and proactively address customer needs; Able to make customer satisfaction a high priority NEGOTIATE: Able to apply effective questioning and listening techniques to determine each party's position; Able to look for common ground and build on areas of agreement to reach win-win outcomes; Able to ensure the agreed-upon alternatives have the support of all parties involved DO WHATEVER IT TAKES: Able to maintain perseverance in the face of obstacles; Able to take charge, know what is needed or find out, and move forward; Able to stand up for ideas in the face of resistance; Able to work with others to expand on ideas PLAN: Able to develop short- and long-term operational and / or financial plans that are appropriately comprehensive, realistic, and effective in achieving goals; Able to anticipate obstacles and define alternate strategies; Able to integrate planning efforts across work units BE PROFESSIONAL: Able to project a positive, professional image with both internal and external business contacts; Able to create a positive first impression; Able to gain respect and trust of others through personal image and demeanor SOLVE PROBLEMS: Able to apply both rational and creative processes and approaches to identify root causes of problems and solutions INFORM: Able to keep all appropriate parties up-to-date on decisions, changes and other relevant information SPEAK COMPETENTLY: Able to speak clearly and concisely; Able to use appropriate vocabulary for the audience; Able to get point across unambiguously and check for understanding PRESENT SKILLFULLY: Able to prepare and deliver clear, effective, and professional presentations Education & Experience Requirements Bachelor's Degree required. Masters Degree preferred. Degree in Mechanical or Biomedical Engineering preferred with a solid technical understanding of medical devices and ISO 13485 requirements. Project Management Professional (PMP) Certification preferred. Six (6) to eight (8) years work-related experience required, preferably in Engineering or Technology fields (i.e. R & D, product design/development, road map processes, etc.). Or an equivalent combination of education, training or experience....

Associate Engineering Advisor

The purpose of this role is to provide technical project management expertise and project coordination for Lilly device development projects. These device projects are complex, involve many technical components, require interaction with many internal and external stakeholders, and can represent significant expenditures ($10 - $20MM). These individuals, viewed as device subject matter experts throughout the company, are responsible to interface with all functional groups inside and outside of Lilly?s Delivery Device Research and Development group. These individuals provide key decision-making and problem-solving leadership for the device projects which they lead with individuals from other functions supporting devices, the rest of Lilly functional groups, as well as external development, manufacturing and pharmaceutical partners. KEY OBJECTIVES/DELIVERABLES Manage All Key Project Deliverables This individual is responsible for the management of: Scope: defining and managing the scope of assigned device development projects; Cost: The individual is responsible for assessing the costs of the device portion of the development projects: Development Costs: including external research dollars and internal labor and charges to the project; Capital: local or development capital; Headcount: managing the internal resources supporting the effort; Time: This individual is responsible for the development of, coordination of, and update and conformance to a MS Project Timeline, Critical Chain timelines, and track the activities of the device-related resources for their project(s), and; Product Team and Management Updates: this individual is responsible to own and manage all internal communications with CM&C Project Manager(s) and/or Senior Management communications (updates, issues, resource needs, timeline concerns, etc) for their project(s). This individual not only facilitates alignment of the many varied customers for these projects, but, when required, leads the ?trade-off decisions? that must be made. They provide the means of enabling the scope, cost and time to be updated and aligned to ensure successful completion of the project expectations. Coordination This individual is responsible for leading the project-related coordination with: Lilly?s Device Business: for all project-related coordination with the rest of the Lilly Device business: Quality Assurance (e.g., to ensure the appropriate involvement with QC Reps for Audits), Delivery Device Research and Development Leadership, as well as other internal Device functions (Finance, etc); Lilly Internal: for all regular contact and coordination with the rest of Lilly for its drug development team(s) (including the Lilly Project Leader and CM&C Project Management, with internal Lilly customers (Program and Product Team leadership), as well as the PR&D Leadership for updates as needed, and; External Partners: for being the key contact to manage the deliverables and relationships with any external (Development, Engineering or Manufacturing) partners, as well as with any external pharmaceutical partner(s). Coordinate Device Risk Assessment and Design Control Deliverables This individual is responsible for: Ensuring a thorough technical, project and business risk assessment is conducted and updated; Ensuring appropriate formal approval of required risk assessment documentation is accomplished, and; Ensuring all required design control deliverables are completed (including ensuring the completion of required Phase documentation and Phase closure), and to facilitate timely product launches. It is this individual?s responsibility to identify potential project risks (business, technical, funding, organizational alignment ? and bring it to the attention of the appropriate management and governance bodies. They are also responsible for identifying various project alternatives which could either mitigate the risk or minimize its impact. Provide Project Management Expertise ?Mentoring? to other Project Managers across Delivery Devices : Provide expertise to others in Delivery Device Research and Development in Project Management expertise. Technical Skills The candidate for this position should have the following skills and/or background: Project Management Expertise: This position requires a level of expertise in general project management skills, and a familiarity with the major steps required in technical product development, especially in a regulated environment. Individual must be able to coordinate the roles of multiple other groups and individuals, internal and external. Familiarity in the use of Project Management software systems: (e.g., MS Project), as well as other project timeline and financial tracking tools (e.g., Excel and internal Lilly systems (SAP)). Experience in Product Development, Commercialization and Product Launch : Experience in product development including early stage product selection, an understanding of customer needs, and knowledge of industry trends, through maintaining contacts in device community. Must be familiar with planning global launch forecasts and scheduling, to facilitate long-term product planning. Exposure and general familiarity with validation and scale-up issues. Ability to identify program risks, evaluated contingency plans, and implement these plans to minimize risk to the project. Basic Engineering/Technical skills : Proficiency in basic engineering analyses, including design, stress, tolerance, and finite element. Proficiency in engineering design and analytical tools (e.g. Failure Modes and Effects Analysis (FMEA), Design Of Experiments (DOE), analysis of injection molded or machined components, Design for Manufacturing (DFM)). Broad technical expertise (e.g., background in Biomedical, Mechanical, Electrical, and/or Plastics Molding). Must be able to provide direction in competitive analysis of delivery technologies. Computer Analytical Experience : Proficiency in use of technical and business tools for analysis and presentation (Word, Excel, PowerPoint) Understanding of other analytical tools (e.g., Quality Function Deployment (QFD), FMEA, mold flow analysis). Strategic Thinking: The role requires strategic thinking to help assess the balance between technical risk, business impact, financial analysis (development costs and revenue projections), and customer preferences....

Validation Engineer

Job Classification: Full-Time Regular Connect confidentially with MRIGlobalMedDevice at: This manufacturer is at the cutting edge of technology in the medical device industry! As they continue to grow with steady revenue from existing products and tremendous potential for soon-to-be-released products, the need to hire the best and brightest people is as strong as ever. To develop this talent, they provide an exciting and dynamic environment. To retain this talent, they provide outstanding compensation and a comprehensive benefits package. Take advantage of this tremendous opportunity to realize your potential with an industry leader advancing toward new horizons! Essential job responsibilities include, but are not limited to: Act as the lead technical resource for operations based project initiatives to maintain the existing portfolio of products. Interface with a multidisciplinary team (manufacturing, materials, purchasing, and development engineering) in order to ensure success of their assigned projects. Be the technical resource for injection mold tooling transfers between multiple suppliers Complete the tooling transfers, through qualification of multiple injection molding tools to multiple vendors, on time and within budget...

Director of Research and Development

Bartlett, TN - The Director of Research and Development works closely with the Executive Team, Business Managers, Business Engineering Leaders, Marketing, Product Management, Manufacturing and Sourcing functions to ensure delivery of new products and product changes according to the business Annual Operating Plan. EOE M/F/D/V...

Clinical Engineer

Bachelors Degree Preferred Manages the inspection, testing, calibration repairs and preventative maintenance on clinical and non-clinical hospital equipment and systems. Researches and implements innovative and new technologies within the facility. BS strongly preferred, AS minimum in Electrical Engineering Technology, an Allied Science, or equivalent. Certification as Biomedical Equipment Technician (CBET) or eligibility for certification....

Sr. Wearables Android Engineer

Logistics Title: Sr. Android Engineer Location: San Francisco, CA Duration: Full Time Rate: $145,000-$160,000 + stock + bonuses Industry: Health, Fitness, Wearables Come join one of most innovative wearables company which monitors health, fitness, and sleep. This company builds out the wrist-worn device and web and mobile service captures physiological metrics such as heart rate to help people get fit, sleep better, and stress less. Through these wearable devices, it delivers a comprehensive picture of your health by tracking heart rate, temperature, perspiration, motion, and sleep. With its multiple sensors, the company is also the only health tracker that differentiates REM, light, and deep sleep. To create this technology ecosystem, this company has built an amazing team of multi-disciplinary engineers, designers and experts from industries as diverse as gaming and biomedical engineering. We are looking for a mid-level and senior mobile software engineer with strong Android experience who wants to build engaging apps that unlock the power of our advanced wearable fitness technologies. Responsibilities: Work in a small team to extend the Basis mobile applications for Android. This app allows users to upload biometric data from their watches and interact with it in ways that encourage healthy behaviors. Develop in Java using the Android SDK/OS Implement new features and capabilities using Bluetooth Low Energy communications between the wearable watch and the mobile apps. Use our RESTful Web API for communications between the Mobile apps and our Basis servers. Collaborate with firmware and backend development teams to implement new features. Collaborate with product and design teams to create engaging new features. Work with Quality Assurance to ensure that we ship high quality apps. Be a great team member, both learning and helping others learn. Qualifications Minimum Requirements: Bachelor's degree in Computer Science or equivalent experience. - You have shipped Android applications that use Bluetooth. Please include a link to screenshots and reviews of your app. - 3+ years programming in Java. - 5+ years programming in a strongly-typed object-oriented language (C++, Java). - 5+ years professional, full-time work experience. - Experience using at least one RESTful API. Bonus points if you've designed one. - Experience using Eclipse or IntelliJ IDE's. Preferred Qualifications: Experience with byte-level serial communications. At some point (it could be years ago), you've written some firmware or assembly/microcode. Experience with automated testing and test driven development. Bonus if you have worked with Bluetooth LE communications and GATT. Experience at startups, willingness to tackle problems outside of prior expertise. Interested in health and fitness. Come join the fun! It's amazing working on a product that helps people improve their health - and that you can physically show off to your friends and family. Thrive in a fast-paced environment. Strong communicator - must be able to interact with product managers, designers, and other non-technical stakeholders. Even if this opportunity doesn't sound like a good fit for you, feel free to reach out to Eileen Wu, mobile recruiter about other great Bay Area mobile opportunities at ewu(at)teksystems.com. About TEKsystems: Join TEKsystems®, a leading IT staffing, IT talent management and IT services firm, and get your career on the fast track. We have more than 100 offices worldwide, and we partner with over 6,000 clients and place over 80,000 consultants per year. At TEKsystems, we seek to understand our consultants? skills, goals and interests, allowing us to present targeted job opportunities on a contract, contract-to-hire or direct placement basis. TEKsystems' leadership in the market stems from our sincere and personal commitment to driving the success of our customers, consultants and each other....

Biodefense Laboratory Validation Engineer

Growing and well-respected biomedical (clinical, basic and applied) research firm has openings at USAMRIID . If you are passionate about research, and are looking for a firm that shares your passion, and provides competitive salaries with a strong benefits package, join the ClinicalRM team. We are currently seeking a Biodefense Laboratory Validation Engineer for the Frederick , Maryland area. RESPONSIBILITIES: The following duties will be performed for this position: Development, execution, data analysis and reporting of validation and qualification activities for laboratory instrumentation to meet GLP requirements. Employ a risk-based approach to qualification and validation activities, including a validation maintenance program. Under general supervision, review and provide authorization when justified for proposed changes to qualified/ validated systems. Identify the qualification/ validation requirements necessary to maintain the system?s validated status. Track and report to testing facility management on status of qualification/ validation activities and assists Chief, Regulated Studies on capital improvement initiatives. Provide validation metrics and business analyses for budget and resource planning to division management and above as required. MINIMUM QUALIFICATIONS: B.S. in Chemical or Mechanical Engineering or similar scientific discipline At least 3 years laboratory experience in the pharmaceutical industry Preference will be given to candidates with relevant equipment qualification/validation experience in the pharmaceutical industry; MS combined with above experience preferred. The contractor must be a US Citizen and must have a favorable National Agency Check with Law and Credit Coverage (NACLC) submitted prior to reporting for the first day of work. Must be able to work independently following a brief period of specific technical training. Qualified candidates will receive consideration for employment without regard to race, color, religion, sex, or national origin. Candidates for positions under ClinicalRM?s contracts with the Department of Defense (DoD) will be required to pass one or more background/security investigations conducted by the DoD, U.S. Army, or other Federal Government agency. Such investigations may include criminal records and credit history checks. ClinicalRM is an Affirmative Action-Equal Opportunity Employer www.clinicalrm.com ?NorthCoast 99? Best Places to Work recipient...

Field Service Engineer

Company Description Leica Biosystems (LBS) is a world-leading biomedical business specializing in solutions for histopathology predominantly used for cancer diagnosis and research. Leica Biosystems is part of Leica Microsystems, a wholly owned subsidiary of the Danaher Corporation. The organization has been aggressively investing in Medical Technologies that enhance patient care, treatment and diagnosis. Leica Biosystems was formed following the acquisition of the then listed Vision Systems Ltd. (Melbourne, Australia) and integration with Leica?s own Sectioning and Specimen Processing business. The combined businesses have created the most comprehensive product portfolio for histo-pathology in the market. Leica Biosystems is the only source to offer instruments for the entire histo-pathology process, as well as the Novocastra? range of antibodies and reagents. In the last four years Leica Biosystems has in average, outgrown the market with a strong double digit Core Growth rate. Specifically Leica Biosystems offers Advanced Staining Systems and Reagents as well as Histology Systems and Materials Sectioning products. About the Role: The Field Service Engineer will provide technical service and support on equipment within the company, ISO, FDA, and budgetary guidelines with the objectives of minimizing customer downtime and generating revenue opportunities for Leica. This position reports to a Regional Service Manager. Key Responsibilities: Provide installation support, maintenance, modification and/or repair on various mechanical, electro-mechanical, electronic and refrigeration instruments. Effectively communicate with internal colleagues and external customers within established time guidelines in order to meet customer?s expectations. Document and complete service administration activities in a timely manner in order to comply with ISO, FDA, and Leica policies. Actively support the sale of service contracts, assist sales representatives and service team members with system configurations and upgrades, and provide input on ways to improve financial performance in order to generate service revenue. Broaden knowledge and experience to improve product, application and professional development skills and ultimately, represent the company in a professional manner. Maintain spare parts stock within budgetary limits in order to maximize customer uptime and field service related metrics. Control expenses in order to maximize the profit contribution to the company. Represent the company in a professional manner in order to instil confidence with current and prospective customers of Leica products to achieve high customer satisfaction....

Quality Engineer II

Quality Engineer II Position Summary Utilize Quality Engineeringtechniques to ensure thatCryoLife complies with allapplicable federal, industryand corporateprocedures, guidelines andregulations forvalidation/calibration duringthe receipt, storage,manufacture and distributionof products. Responsibilities Assist in the implementation of corporate policies and procedures relating to quality, project management, process development and Quality System Regulation/ISO compliance by periodically reviewing specifications for functionality and initiating the required changes, establishing procedures and integrated program plans for achieving reliability in accordance with specifications and procedures. Design, prepare, execute and analyze validations/calibrations to approve equipment, processes and software used in the testing, processing, storing and distribution of products. Collect, statistically analyze and develop report packages to support validations, engineering studies and/or calibration data. Develop, conduct and document qualifications/validations/cali brations to ensure that the products processed are proven to be reliable, safe and effective prior to release. Coordinate validation/calibration activities, and scheduling, in support of corporate projects. Effectively complete other responsibilities that may be assigned. Work Schedule: 8:30a.m. to 5:30 p.m., Monday -Friday...

Engineer I - R&D

This position will help facilitate the transfer of new technology, processes and/or intraocular lenses from R&D to the manufacturing environment. The role will assist in the development of new products and associated tooling and processes and contribute as team member on large projects and/or manage small scale projects....

Quality Engineer

Overview: This position is responsible for the Quality Assurance and Control processes within the Service organization. This position will be responsible to review the output of Servicing and Complaint Investigation activities to ensure that the resulting work complies with all regulatory requirements, as well as facility, divisional, and corporate objectives. Summary of Position with General Responsibilities: Essential Job Functions: ?Ensure that Complaint Investigations and Servicing activities are thorough, complete, self-explanatory, and completed in a timely manner. ?Assist technicians in establishing investigation criteria and, as needed in troubleshooting returned products to identify root causes of failures ?Assist in quality investigations with Divisional Field Assurance and Engineering to identify causes of service and complaint trends. ?Provide ongoing training to Service staff on regulatory requirements associated with complaint investigations ?Review and approve completed service records for accuracy ?Participate in Product Transfer teams to assist in developing service repair processes for new or transferred products ?Participate in the development and review of engineering change orders that impact servicing activities ?Work with Engineering to design and implement tooling and fixturing required to perform servicing activities. ?Perform DHR, Service History record, and PFMEA reviews in support of complaint investigations ?Coordinate complaint investigation activities with divisional Field Assurance ?Review and monitor monthly service reports for trends ?Prepare monthly reports on Complaint Investigation findings and trends ?Support the goals of the Quality Organization, Continuous Improvement efforts and Cost Improvement Projects. ?Other duties as assigned....

Research Engineer

MED Institute, Inc. is currently accepting applications for a Research Engineer to become a part of our growing Product Discovery team. The successful candidate will support and lead research and development of novel medical devices. The candidate will work within an interdisciplinary team of engineers and scientists evaluating novel design concepts for new medical products and will also be expected to independently formulate new concepts and produce prototypes. Familiarity with a variety of medical device materials would be advantageous. Responsibilities Collaborate with and lead interdisciplinary teams of scientists and engineers to discover and develop novel medical devices; Develop methods for prototype device fabrication; Take a ?hands on? approach to fabrication of concepts and prototypes; Research new technologies and integrate new capabilities into the product development team; and Lead and assist in the development of experiments, execution, analysis of results, interpretation and reporting of results; Identify problems and propose + develop approaches for solving them. Essential Qualifications MS, or PhD in Engineering (Mechanical, Biomedical, Materials, etc) or a related field; Experience with medical devices is strongly preferred; Experience working in and leading multidisciplinary teams is beneficial; Must be highly flexible, have a hands-on approach and be willing to take the initiative; and Ability to communicate well through written and verbal means is required....

Polymer Engineer - Medical Devices

Sr. Polymer Engineer - Medical Devices Global leader in the development and production of life polymer based medical devices seeks a Sr. Polymer Engineer to provide a leadership role in product materials selection, design and development of new medical devices. The Sr. Polymer Engineer will lead the execution of Design for Excellence - DFX - aspects of processes and design. The Sr. Polymer Engineer should have extensive knowledge of at least one area of polymer processing. The Sr. Polymer Engineer will also: Design, develop, and qualify products and processes, including running feasibility studies, designing and implementing evaluations - DOEs - and providing technical input for justification of project and design. Responsible for Contribute to the Design History File - DHF - and regulatory submissions, creating SOP?s, and providing training to ensure proper design transfer. Perform as a technical lead on a large project to lead and implement the technical aspects involving coordination with other departments, prototype fabrication and/or testing. These could include organizing and leading members of the design and transfer group, planning and scheduling technical activities, coordinating technical resources, and preparing proper documentation....

Project Engineer

Oscor Inc. is a global US based medical device company headquartered in Palm Harbor, Florida. Oscor designs, manufactures and sells a variety of highly specialized implantable cardiac pacing leads, venous access systems and diagnostic catheters with sales to over 65 countries internationally. As a leading manufacturer of medical devices in the area of cardiology, electrophysiology and radiology, Oscor offers excellent career opportunities and great benefits within a fast-paced and challenging environment. The Project Engineer will be responsible for coordinating new product development according to customer specifications, developing hands-on product solutions and improving manufacturing methods, systems and processes to produce a high quality product at optimal cost. The Project Engineer manages a complete device project from the early development stage, through detailed manufacturing process development to technology transfer to production floor. Position Responsibilities Coordinates new product development with customers or according in-house requirements. Generates all required documentation in support of the development and manufacturing products and processes, including timelines, responsibilities, engineering protocols, IQ, OQ, PQ reports, bill of materials, assembling instructions, manufacturing instructions and procedures. Conducts component and device testing. Accurately generates standard written reports. Develops plans to evaluate process repeatability and stability through equipment qualification and process validation. Ensures compliance with QSR and internal protocol. Use appropriate statistical support and Design of Experiments (DOE) when developing recommendations. Designs, develops, and implements basic manufacturing fixturing and tooling. Works with internal manufacturing as well as outsourced partners to develop metrics such as labor time, yields, statistical analysis, qualification and validation of process, tooling and equipment. Provides support in the resolution of product complaints and/or safety issues. Works with various departments to facilitate pilot production of new products. Support company goals and objectives, policies and procedures, Good Manufacturing Practices, and FDA/QSR regulations. Transfer as required engineering project from engineering into manufacturing....

Field Service Technician- MN

Blue Belt Technologies, Inc., a Pittsburgh-based medical device company, was formed in 2003 to commercialize novel hardware solutions for medical interventions Position Summary : This position works under the supervision of the Service Manager. Consults with Manager on a daily basis to understand priorities, assignments and for technical expertise. Position Responsibilities : ? Provide service to Blue Belt product in the field and at Blue Belt facilities. ? Coordinate service visits with Blue Belt and customer contacts. ? Schedule travel arrangements and complete expense reports in a timely manner. ? Provide technical and operational training as needed. ? Complete service documentation in a timely manner. ? Troubleshoot and resolve system issues. ? Utilize phone skills to assist Clinical Representatives with troubleshooting to resolve system issues. ? Create drawings, documents, and procedures to support depot and field service processes. ? Communicate status and provide updates routinely. ? Works within the confines of the established document control policies and procedures. ? Provides feedback to Engineering regarding system performance issues, suggestions to improve field testing. ? Becomes subject matter expert regarding system performance, error code interpretation, and resolutions to system issues....

Senior Principal Engineer

JOB TITLE: Senior Principal Engineer THE CHALLENGE: Sterling Engineering is assisting a premier client in their search for a Senior Principal Engineer. This is a Contract assignment located near Waukegan, IL. THE ROLE YOU WILL PLAY: This position will be responsible for supporting parenteral/injectable medical device / combination product development being performed with external development partners and suppliers. Supporting technical staff and the contract medical device manufacturers and technical consultants for the development of drug delivery devices and related components, you will be responsible for: ? Developing appropriate system-level requirements, specifications, test methods and technical studies in support of combination product development activities as required. ? Establishing engineering laboratory capabilities for device functional testing, characterization and measurement method development. ? Generating Design and User FMEAs. Developing and executing both system and component level test plans to identify design robustness and potential weaknesses. ? Assessing component manufacturing process capability. ? Evaluating device subassembly and final assembly processes using your parenteral sterile product manufacturing experience. ? Managing multiple project plans to ensure that deadlines are met on time and on budget. REQUIREMENTS: ? BS / MS in Engineering with a minimum of 5 years of experience in medical devices. ? Experience with medical device design and development, mechanical systems integration and testing. ? Knowledge of high speed automated filling and assembly processes. ? Experience in High-volume injection molding, dimension inspection method development. ? Some measurement method development experience. ? The ability to effectively communicate, both written and verbal, with all levels of the organization and with development and manufacturing partners and suppliers. ? Working knowledge in the use of a CAD software such as Solidworks (preferred), ProEngineer or AutoCAD. ? Basic understanding of medical device regulations (QSR 820 and cGMP Parts 210 / 211) and applicable guidance. ? Strong project management and leadership skills. ? Experience in the development, launch and/or support of medical devices is preferred. CONTACT: WENDY WHELTON Business Development Manager P: 630-993-3428 | E: Visit our website | Connect on LinkedIn | Corporate Office: 977 N. Oaklawn Ave. Ste. 300, Elmhurst, IL 60126 Wisconsin Office: 125 N. Executive Dr. Ste. 101, Brookfield, WI 53005 70618 COMPANY: Sterling?s in-depth knowledge, industry expertise and robust talent pipeline delivers a diverse range of creative candidates for even the most complex engineering projects both nationally and internationally. Sterling builds and maintains long-term relationships with clients that allow our talented teams grow their careers through a variety of assignments that broaden their range of experience and challenge their potential. With over 500 employees, Sterling enjoys exclusive relationships with many of our clients and offers a wide range of opportunities on a contract, contract to hire and direct hire basis that may not be available through other avenues. We offer one of the most comprehensive benefit packages in the industry which allows us attract and retain some of the industry?s top talent. For more information visit www.sterling-engineering.com...

Software Engineer - Algorithm Development (1093-547)

ZOLL LifeVest, a Pittsburgh-based subsidiary of ZOLL Medical Corporation, develops, manufactures and markets a wearable defibrillator for persons with Sudden Cardiac Arrest (SCA) risk in the United States and Europe. The LifeVest is worn by patients at risk for sudden cardiac arrest (SCA), providing protection during their changing condition and while permanent SCA risk has not been established. The LifeVest allows a patient?s physician time to assess their long-term arrhythmic risk and make appropriate plans. The LifeVest is lightweight and easy to wear, allowing patients to return to their activities of daily living, while having the peace of mind that they are protected from SCA. The LifeVest continuously monitors the patient?s heart and, if a life-threatening heart rhythm is detected, the device delivers a treatment shock to restore normal heart rhythm.The LifeVest is used for a wide range of patient conditions or situations, including following a heart attack, before or after bypass surgery or stent placement, as well as for those with cardiomyopathy or congestive heart failure that places them at particular risk. The LifeVest is covered by most health plans in the United States, including commercial, state, and federal plans. Software Engineer ? Algorithm Development Pittsburgh, PA DUTIES : Perform software research engineering for LifeVest Automated External Defibrillator (AED) product development team. Develop signal processing techniques for leveraging core capabilities, and identifying opportunities for innovation of product development for medical devices. Develop advanced digital signal processing algorithms for cardiac and other biological signals. Research and develop advanced methods of arrhythmia detection, classification and prediction. Research and develop advanced methods of processing and storing cardiac and other biological signals. Perform data mining and analysis of ECG signals, including ECG signal quality and ECG measurements. Formulate code for real-time evaluation of ECG signals....

Engineering Supervisor

STATEMENT OF PURPOSE Responsible for the functions of the EngineeringDepartment. Oversees programs, with theassistance of the Director of Engineering, to maintain buildings, grounds, andequipment in accordance with applicable national, state and local buildingcodes, and to procure or generate all utilities and their distribution systems;coordinates these activities with the other departments to insure safe andefficient operation. PRINCIPALDUTIES AND RESPONSIBILITIES 1. Acts as Safety Officer in absence ofDirector of Engineering. 2. Assess the current condition ofelectrical, air conditioning, plumbing and other essential facilities andequipment. 3. Maintains accurate records of thecondition of the equipment and other systems in the building. 4. Works with Director of Engineering onfacility OSHPD projects. 5. Respond appropriately to emergencies orurgent issues as they arise. 6. Participate in the development of policiesand procedures that affect the use of supplies and facilities. 7. Ensure that all the equipment and otherfacilities are working properly and are in good working condition. 8. Initiate interventions to solve problemsin the facility. 9. Ensure the safety of the building(s) fromfire, flood and other hazards and that building(s) meet health and safetyrequirements. 10. Prepare records and reports as needed. 11. Coordinate work of vendors andcontractors. 12. Enter all data related to the PreventativeMaintenance Management Program. 13. Ensure all required testing is performedas per current Title 22, NFPA and The Joint Commission standards. 14. Train engineering staff as needed toensure competent work output. 15. Evaluate the work quality of staff. 16. Coordinate with Director of Engineering onwork issues. 17. Performs other tasks as assigned byDirector of Engineering....

Desktop Support Analyst Help Desk Analyst

DEPARTMENT: Information Technology Services JOB TITLE: Desktop Support Analyst FLSA STATUS: Non-exempt If you are a responsible and self-motivated Desktop Support Analyst who is looking for career advancement opportunities and a stable employment with a great group of Information Technology professionals, join our IT team at BioBridge Global (BBG)! We are seeking a Desktop Support Analyst to support internal and external customers at both local and remote sites and troubleshoot over the phone and alongside the customer. As a Desktop Support Analyst with BBG, you will report to the Desktop Support Manager, maintain and repair enterprise desktops and the applications that they run and perform tasks assigned through the enterprise ticketing system. You will also answer the help desk line, drive to remote centers to provide assistance and document all the work activities you perform. Desktop Support Analyst-Information Technology Help Desk Analyst Job Responsibilities As a Desktop Support Analyst with BBG, you will perform high-level support-server testing, manage applications to deploy software and support the Security and Networking teams. You will also install PCs and desktop applications, perform upgrades as assigned, perform level I and II troubleshooting and rotate on-call customer service duty with your colleagues. Additional responsibilities of the Desktop Support Analyst include: Overseeing the installation and maintenance of all desktop computers, laptop computers and related peripherals Using Ghost to load system images Using remote control software to resolve desktop issues Attending and participating in staff meetings and related activities Attending workshops to remain up-to-date with desktop support issues Complying with all Standard Operating Procedures and policies, including those related to BBG?s biomedical department Performing other tasks as assigned Desktop Support Analyst-Information Technology Help Desk Analyst...

Validation and Verification Engineer (3861-446)

About us: Bio-Rad Laboratories, Inc. (NYSE: BIO and BIOb) designs, manufactures, and distributes a broad range of innovative tools and services to the life science research and clinical diagnostics markets. Throughout its existence, Bio-Rad has built strong customer relationships that advance scientific research and development efforts and support the introduction of new technology used in the growing fields of genomics, proteomics, drug discovery, food safety, medical diagnostics, and more. The Clinical Diagnostics Group develops, manufactures, sells, and supports a large portfolio of products for laboratory diagnostics. Bio-Rad is a leading specialty diagnostics company and its products are recognized as the gold standard for diabetes monitoring and quality control (QC) systems. Bio-Rad's clinical diagnostics products incorporate a broad range of technologies used to detect, identify, and quantify substances in bodily fluids and tissues. The results are used as aids to support medical diagnosis, detection, evaluation, and the monitoring and treatment of diseases and other medical conditions. We are currently seeking a Verification and Validation Engineer in our Benicia, CA location. About the position: The V&V Engineer serve as the subject matter expert for all V&V activities. Key responsibilities include: Develop and execute verification protocols to verify engineering specifications Develop and execute validation protocols to validate customer requirements Build and maintain test fixtures as required. Analyze verification and validation test data Document test protocols and reports Conduct root cause analysis using test data and/or field failure data Develop and verify/validate effective countermeasures against root cause(s) of failure Apply Design for Reliability (DfR) methodology to drive reliability improvements Develop and execute ALT, HALT, and other reliability test methods as appropriate Required Skills: A successful candidate will have: BS/MS in Mechanical/Electrical/Biomedical/Industrial/Optics Engineering or Physical Sciences Six Sigma Green Belt, preferred 2-5 years of experience in medical device/FDA regulated industry with experience in: Test Implementation, Verification & Validation, Change Implementation, Risk Assessment, Root Cause Analysis, Development of Corrective Actions Familiarity with FDA regulatory requirements and all internal quality standards Hands on application of Statistical Analysis and Design for Six Sigma (DFSS) Methods Good understanding/working knowledge of Fluidics, Optics, and Electronics Basic understanding of Organic Chemistry Highly proficient in the use of MS Office Suite (Word, Excel, Power-point, Project) Proficient in the use of Minitab and/or other statistical analysis software Ability to work effectively in teams - cross-functionally and within engineering Demonstrated project leadership and organizational skills Strong organizational skills, demonstrated attention to detail, and good written and verbal communication and presentation skills are essential Demonstrated teamwork and leadership skills required If you are a self-starter who enjoys the challenges and rewards of working in a growth-oriented, global organization, and if your background matches these qualifications, we'd love to hear from you! Bio-Rad Laboratories is an EEO employer, we value diversity in our employees and customers....

Technical Sales Engineer

The role of the Technical Sales Engineer for the OEM business will report to the National Sales Manager and will be responsible for serving customers by identifying their needs for engineering adaptations, products, equipment and services. Principal Responsibilities: ? Meet with new and existing OEM customers to explain/recommend Teleflex Medical OEM?s products, design capabilities, and production facility capabilities. Travelling to visit potential clients. ? Prepare quotes by studying drawings, plans, and related customer documents; consult with finance, plant engineers, demand planning, and other professional and technical personnel. ? Analyze costs and sales ROI. ? Prepare Sales Funnel and Forecasting Reports. ? Exceed Quarterly and Annual Sales Targets. ? Record and maintain client contact data. ? Support marketing by attending trade shows, conferences and other marketing events. ? Make technical presentations and demonstrate how a product will meet client needs. ? Provide pre-sales technical assistance and product education. ? Work with customers to resolve issues. ? Assist in the design of custom-made products. ? Provide training and needed support material for members of the sales team. ? Comply with FDA and ISO Quality Systems requirements. ? Account for all territory expenses and materials. ? Position will require 50+% travel in the local territory....

Solid Phase Technician

Manufacturing Technician ? Solid Phase/Production ? Pharmaceuticals Norcross, Georgia in the greater Atlanta area At Immucor, we are a company in the biomedical technology field that has a history of innovating to improve transfusion medicine and transplantation diagnostics. We have two business units now: Transfusion Diagnostics, which includes our traditional serology products; and Transplant and Molecular Diagnostics, which includes the BioArray Solutions and LIFECODES products. We partner with thousands of hospitals, laboratories and donor centers across the globe. Immucor is seeking a Solid Phase Technician to join our manufacturing team. We play a vital role in making blood transfusions safe for patients world-wide by providing blood banks with products and services that drive efficiency and productivity. As a Solid Phase Technician you will perform a variety of tasks associated with the manufacturing operations of solid phase plates for Immucor products. For this manufacturing position qualified Technicians will have a strong work ethic. Manufacturing Technician ? Solid Phase/Production ? Pharmaceuticals Job Responsibilities As a Solid Phase Technician you are responsible for performing manufacturing operations according to department procedures, specifications or work instructions and completing tasks within procedure/work instruction-defined time frames. Additional Technician responsibilities: Creating legible written records Verifying product produced and labeled accurately Following appropriate control measures to prevent mixing of dissimilar solid phase components or product Calculating accurately solid phase components used, rejected or returned Following applicable laboratory OSHA safety regulations with respect to chemical hazards, blood borne pathogens, etc. Performing department and equipment maintenance and calibration and environmental monitoring according to applicable procedures Understanding FDA regulations and ISO standards applicable to department operations and consequences of nonconformance Maintaining a neat, clean and orderly work environment Participating in the training of new employees Manufacturing Technician ? Solid Phase/Production ? Pharmaceuticals Job Requirements We are looking for highly motivated technicians with a strong work ethic and attention to detail. Experience working in an aseptic environment is preferred. Additional Technician requirements: High School diploma OR GED required, Associates Degree in Life Science, Engineering or Automation field, preferred WorkKeys Silver Level ACT National Career Readiness Certificate (NCRC)preferred Ability to accommodate production requirements that may require 50+ hour workweeks, including extended day hours and weekend Ability to use hands to process product and perform visual inspection of product for defects and correct fill volumes Ability to offload product off carts and onto pallets; move transfer carts in and out of coolers Ability to stand over intervals of several hours at a time Ability to stand for longer periods, bend, squat, and reach Ability to lift, push or pull various amounts of weight Manufacturing Technician ? Solid Phase/Production ? Pharmaceuticals IMMUCOR, INC IS AN EQUAL EMPLOYMENT OPPORTUNITY/AFFIRMATIVE ACTION EMPLOYER; MINORITY//FEMALE/DISABILITY/VET; *DRUG FREE WORKPLACE RESUMES SUBMITTED TO IMMUCOR FROM THIRD PARTY RECUITMENT FIRMS WILL NOT BE CONSIDERED...

Manufacturing Technician? Pharmaceuticals

Manufacturing Technician ? Solid Phase/Production ? Pharmaceuticals Norcross, Georgia in the greater Atlanta area At Immucor, we are a company in the biomedical technology field that has a history of innovating to improve transfusion medicine and transplantation diagnostics. We have two business units now: Transfusion Diagnostics, which includes our traditional serology products; and Transplant and Molecular Diagnostics, which includes the BioArray Solutions and LIFECODES products. We partner with thousands of hospitals, laboratories and donor centers across the globe. Immucor is seeking a Solid Phase Technician to join our manufacturing team. We play a vital role in making blood transfusions safe for patients world-wide by providing blood banks with products and services that drive efficiency and productivity. As a Solid Phase Technician you will perform a variety of tasks associated with the manufacturing operations of solid phase plates for Immucor products. For this manufacturing position qualified Technicians will have a strong work ethic. Manufacturing Technician ? Solid Phase/Production ? Pharmaceuticals Job Responsibilities As a Solid Phase Technician you are responsible for performing manufacturing operations according to department procedures, specifications or work instructions and completing tasks within procedure/work instruction-defined time frames. Additional Technician responsibilities: Creating legible written records Verifying product produced and labeled accurately Following appropriate control measures to prevent mixing of dissimilar solid phase components or product Calculating accurately solid phase components used, rejected or returned Following applicable laboratory OSHA safety regulations with respect to chemical hazards, blood borne pathogens, etc. Performing department and equipment maintenance and calibration and environmental monitoring according to applicable procedures Understanding FDA regulations and ISO standards applicable to department operations and consequences of nonconformance Maintaining a neat, clean and orderly work environment Participating in the training of new employees...

Technical Writer

Are you looking for a career with a company that offers innovative products? Do you enjoy interacting with people? Want to put your technical expertise and writing skills to great use? ATI Industrial Automation is the leading engineering-based world developer of robotic accessories and robot arm tooling. Recognized throughout the world for quality and reliability, ATI products are improving productivity in an array of industries, including Robotics, Aerospace, Biomedical, Automotive, Electronics, Applied Research, Academics, Nuclear and Governmental. In our continued quest for excellence in our products and service, we are seeking an experienced, hardworking, team-oriented Technical Writer. Major Duties and Responsibilities Write technical manuals (user manuals, training manuals, technical reports for customer reference, or publications.) for ATI products with input from the project leaders. Analyze technical descriptions, write descriptive copy, and verify documentation with engineering, sales, and applications personnel. Bring a uniform tone to all company communications and policies so that there is a consistent voice throughout. The technical writer will create many different types of user documentation. Organize material and complete writing assignment according to set standards regarding order, clarity, conciseness, style, and terminology. Edit, standardize, or make changes to material prepared by other writers. Make and select photographs, drawings, sketches, diagrams, and charts to illustrate material. Study drawings, specifications, mockups, and product samples to integrate and delineate technology, operating procedure, and production sequence and detail. Interview production and engineering personnel and read journals and other material to become familiar with product technologies and production methods. Observe production, developmental, and experimental activities to determine operating procedure and detail. Continue to learn new skills and techniques through in-house training, outside training/coursework, seminars, trade shows and appropriate use of the internet and participate in the training of other members of the engineering team in these skills....

Senior Process Engineer Medical Device

Valeant Pharmaceuticals International, Inc. is a diverse and decentralized pharmaceutical company that is committed to focusing on our key stakeholders while delivering consistently high performance. Our values provide the overall direction for our company, and provide us with the tools necessary to rise to any challenge by leveraging our collective hard work and effort along with our unwavering competitive spirit. These values help us set goals based on our organization?s potential and what we hope it will become. Participate in new product development, improve product performance, lead product/process evaluations and assist in product approvals and launch....

Sr Quality Systems Engineer

PURPOSE AND SCOPE: Supports FMCNA?s mission, vision, core values and customer service philosophy. Adheres to the FMCNA Compliance Program, including following all regulatory and division/company policy requirements. Provides quality engineering expertise to the analysis and investigation or product quality issues with the intent of reducing complaint levels and improving customer satisfaction. Provides quality engineering support to QS/RA functions and to all RTG manufacturing locations as required, based on both in-process manufacturing and post-market quality analyses. DUTIES / ACTIVITIES: CUSTOMER SERVICE: Responsible for driving the FMS culture through values and customer service standards. Accountable for outstanding customer service to all external and internal customers. Develops and maintains effective relationships through effective and timely communication. Takes initiative and action to respond, resolve and follow up regarding customer service issues with all customers in a timely manner. PRINCIPAL RESPONSIBILITIES AND DUTIES Responsible for coordinating an on-going Corporate Quality Programs (examples are Risk Management, CAPA, Supplier Management, Complaints or Monitoring of Quality Data) that may be assigned to one or more Quality Systems Engineers. Ensure program goals are met by communicating and following-up on schedules with program participants. Responsible for preparing regular progress reports on their programs. Institutes corporate policies and procedures; ensures all parties receive appropriate training. Publishes regular updates regarding the integration status reports. Participates as a member of the facilities Audit Team in performing internal and external audits as required. Assist in providing in-house training (e.g., risk management, statistical sampling, CAPA) in conjunction with corporate training department to plant staff, as assigned. As required, assumes responsibility for timely completion of Adverse Trend Investigation Reports, including obtaining agreement/commitment to Corrective Preventive Action recommendation. Monitors and follows-up regularly regarding the implementation and effectiveness of Corrective & Preventive Actions recommended in ATIRS. Establishes personal quality improvement goals. Has the authority to issue a STOP NOTICE to immediately stop production when a concern regarding possible production, stocking, or shipping of discrepant assemblies or product arises. Other duties as assigned....

Mechanical Project Engineer- New Product Development

DJO Surgical has an immediate opening for a Mechanical Project Engineer position located in our Austin, TX manufacturing facility. We are located near 183 and Burnet Road in North Austin. We are the largest non-surgical orthopedic rehabilitation device company in the United States and among the largest globally. We also develop, manufacture and distribute a broad range of surgical reconstructive implant products through our DJO Surgical business unit. Summary: Work with a cross-functional product team consisting of upper level product development engineers, marketing product managers, manufacturing engineers, regulatory and QA engineers in the design and development of surgical instruments and implants including hip, knee, shoulder, and trauma devices. Function as a design engineer as well as project manager, managing entire product development process from concept through to production. Essential Duties and Responsibilities: Include the following. Other duties may be assigned. ?Work with marketing and customer to develop conceptual designs, typically in the form of SLA models or metal prototypes of the product and present those designs back to customer for evaluation. ?Maintain all documentation necessary for a Design History File (DHF), including Design Input Documents, Design Verification Plans/Reports, Design Validation Plans/Reports, Test Protocols/Reports, and Design Input/Output Matrix. ?Develop project plans using appropriate planning software and periodically report on the progress of the project to upper management. ?Develop detail engineering drawings and release through ECO system. ?Work through internal prototype shop or contract through vendor on developing prototypes. ?Schedule and direct product team meetings, assuring timeliness of project execution. ?Maintain existing product lines, including attending NMR (Non-conforming Material Report) meetings and disposition product appropriately, attend weekly product complaint meetings and follow through with corrective/preventative actions, and write ECOs for general product improvement. ?Rely on instructions and prestablished guidelines to perform the functions of the job. ?Work under immediate and heavy supervision....

Software Engineer

This position is open as of 10/31/2014. Software Engineer - Android Development, Object Oriented Program If you are a Software Engineer with experience, please read on! Based in Silver Spring, we are a privately held, venture capital backed medical technology company in the Medical industry. Our company is developing a new generation of hand-held, non-invasive instruments designed to aid medical professionals in rapidly and objectively assessing brain function, with an initial focus on Traumatic Brain Injury. What You Will Be Doing The Software Engineer is responsible for developing efficient and fully verified Android and C/C++ code. The position entails working closely with engineers and quality department to execute the full software development lifecycle for current and next generation Traumatic Brain Injury (TBI) devices, thus producing excellent design and testing documentation in addition to great code. General responsibilities include software development in one or more of the following areas: Android Application (SDK, Java for Android OS), Android kernel/OS, embedded C/C++ for ARM processor or Android NDK, software verification and testing. Software testing will include writing and performing procedures that conform to Quality Management/Assurance, FDA and ISO standards at all levels of the software development lifecycle from unit to system. Ideally automation of testing via scripting and database management tools will be developed. What You Need for this Position ? Bachelor's Degree in the areas of Computer Science, Electrical, Biomedical discipline or equivalent is required. ? 2-10 years Android coding experience is required. ? Good understanding of testing processes and software engineering design principles. ? Knowledge of ISO and FDA standards, requirements, and testing protocols is a plus. ? Working knowledge of object-oriented Java for Android OS, C/C++, Database (MS Access, Postgres), embedded development (IAR) ? Knowledge of Linux, automated testing tools, and scripting languages (e.g. Bash, Perl, Python). Familiarity with Labview and Matlab is a plus. ? Experience and knowledge of product development, production methods and systems are a plus. ? Ability to communicate in a clear and concise manner, whether verbally or in writing. ? Work within timelines, resources, and budgets for completion of assigned projects. ? Operate effectively in a multi-disciplinary, team-oriented culture that emphasizes professional development. So, if you are a Software Engineer with experience, please apply today! Required Skills Android Development, Object Oriented Programming, C++, Linux If you are a good fit for the Software Engineer - Android Development position, and have a background that includes: Android Development, Object Oriented Programming, C++, Linux and you are interested in working the following job types: Information Technology, Engineering, Professional Services Within the following industries: Computer Software, Banking - Financial Services, Biotechnology Our privacy policy: Your resume and information will be kept completely confidential. Looking forward to receiving your resume through our website and going over the job in more detail with you! CyberCoders, Inc is proud to be an Equal Opportunity Employer All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, or any other characteristic protected by law. Your Right to Work ? In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification document form upon hire....

Sr. Manager - New Technology Development - Diabetic Devices

Title: Sr. Manager ? New Technology Development, Translational Development Location: New York City, New York JDRF is the leading global organization funding type 1 diabetes (T1D) research. JDRF?s goal is to progressively remove the impact of T1D from people?s lives until we achieve a world without T1D. JDRF collaborates with a wide spectrum of partners and is the only organization with the scientific resources, regulatory influence, and a working plan to better treat, prevent, and eventually cure T1D. As the largest charitable supporter of T1D research, JDRF is currently sponsoring $568 million in scientific research in 17 countries. In 2012 alone, JDRF provided more than $110 million to T1D research. JDRF currently has opportunities for a Sr. Manager ? New Technology Development, Translational Development to be located at our facility in New York City, New York ! The Senior Manager, New Technology Development position within the JDRF research department is designed to drive the successful execution of JDRF?s strategic research plan for accelerating the development and delivery of Artificial Pancreas Systems for the treatment of Type 1 Diabetes (T1D). The incumbent is expected to provide scientific, technical and strategic leadership in driving clinical research and the development of closed loop AP products. The Senior Manager is expected to possess the skills, vision and desire to explore and implement new approaches that will not only accelerate the technologies but develop plans for creation of novel concepts for a robust pipeline. The Senior Manager must have in-depth knowledge in medical device development in the context of clinical translation for safety and efficacy studies, outcomes research and incorporation of improved form factor for increased patient adherence and usage. A deep understanding of the current competitive landscape and demonstrated capabilities in managing a diverse portfolio of device development projects is mandatory. RESPONSIBILITIES: Influence and contribute to the JDRF research strategy by closely monitoring type 1 diabetes research progress and to identify discoveries that are suitable for development aligned with the near-, mid- and long term departmental goals and deliverables Work closely with the VP in development of strategies required to influence organizations that directly impact JDRF research goals and objectives (i.e. NIH, Academic and Industry Collaborators & Regulatory agencies) Organize and lead key JDRF programs aligned with their respective business strategies: o Primary responsibility: Create, implement, and execute projects related to the development and clinical evaluation of closed loop Artificial Pancreas systems and their individual components. Work closely with VP of Artificial Pancreas Strategy to coordinate projects o Secondary responsibilities: Create, implement and manage ongoing research projects for the development of ultra-rapid acting insulins, other hormonal drugs for multi-hormone closed loop systems, data management and decision support tools, exploratory projects such as real time insulin sensing, others Collaborate with investigators and pharmaceutical/biotech partners and seek external input from key stakeholders and opinion leaders as necessary to optimize device development and clinical evaluation Responsible for overseeing programmatic projects with corresponding development plans, budgets, etc., including but not limited to coordination with the grants administration and project management teams, research and business development group, and the regulatory and advocacy teams Represent JDRF Research externally to partners in academia, industry (Pharma, Biotech, Venture Capital entities), government (NIH, regulators) and other disease foundations Support major research partnerships and alliances and act in a scientific leadership role by serving on key joint steering committees when required in the translational projects/partnerships...

Field Service Engr II

Does your work make a difference? Ours does! Patients and their families count on the reliability of our innovative products every single day. Come be a part of it. Founded in 1958, Spacelabs developed the first vital signs monitoring for NASA astronauts culminating in Neil Armstrong wearing Spacelabs telemetry for the moon landing in 1969. We operate in three clinical sectors: patient monitoring and connectivity, anesthesia delivery and ventilation and diagnostic cardiology. Renowned for its open architecture interfacing, Spacelabs is able to connect to a host of hospital data management systems enabling easy flow and review of patient data. Our goal is to provide transformative solutions to aid and accelerate the clinician?s decision making process. Our Mission: To inspire the world to bring the best care experience to patients and families. One patient, one family, one smile at a time. Our Field Service Engineer is responsible for quality service of Spacelabs products and for customer satisfaction within an assigned territory. Works under supervision and performs duties in compliance with established procedures. Excellent technical and communication skills are needed to positively interact with customers and company personnel. Successful candidates will be self-starters, who can independently manage their time and schedules; will also possess analytical/technical abilities and basic business acumen and effectively communicate at all levels of the organization....

Principal Software Engineer

My Client is a world-leading provider of automated systems for high-performance applications in the Electronics, Photovoltaic, Biomedical, Aerospace, and Defense industries. The company has a global customer base of industry-leading manufacturers. They are growing their product-development team to accelerate the deployment of a breakthrough technology in high-volume production. This is a special opportunity to shape the future of manufacturing. There will be a heavy emphasis on hands-on engineering and coding in the beginning, but we are seeking a person who can grow and take on greater responsibility in the near future. Responsibilities Lead development of workstation software Lead development of control-system software Develop specifications, select suppliers, platforms, and components, and write code Define and manage projects, directing internal and external resources Manage the software product lifecycle Collaborate with engineers, scientists and technicians to create innovative new products and applications, and refine and expand the performance of existing products Coordinate with customer and third-party automation engineering and oversee system integration...

Technical Support Engineer

Topcon Medical Systems is a world-leading designer and manufacturer of diagnostic equipment and software for the ophthalmic community. Our imaging, diagnostic, refractive, lens processing and surgical products are preferred by eye professionals throughout the world. We are currently seeking a Technical Support Engineer with our TMS team located in Oakland, NJ ....

Software/Hardware Test Engineer-Medical Device-2 mo. Contract

Johnson Service Group has a2 month contract assignment to port the operating system on an existing devicefrom XP to Win7. As a Test Engineer you willwork with our team to ensure that our medical device products meet allrequirements and their intended use. You will work through all phases of productdevelopment through rollout and into production release and test the system aswe build the system as part of the PDLC of a medical device. Duties andResponsibilities ? Create functional testcases against requirements on assigned projects ? Understand the systemrequirements and necessary software specifications. ? Participate in systemrequirement reviews as required ? Identify and correct testcases /test procedures errors and gaps ? Executes functional,regression, system (E2E) tests according to established verification plan ? Create reusable Test Casesagainst functional/non-functional requirements ? Assist in creating TestBeds, Test Data & setup test equipment for formal/informal tests Black Box and Grey box testing is required. ? Update & Modify TestCases/Procedures and gaps during informal test runs ? Documents problems in adefect/issue tracking system and retests product corrections to ensure problemsare resolved ? Reproduce issues fordiagnosis and troubleshooting purposes ? Support senior testengineers in development of multidimensional traceability ? Preparing and orderingtest supplies ? Responsible to maintainmaterials supply for test group ? Perform related duties asassigned ? Contributes effectively asa member of the team; takes ownership of individual assignments with supportfrom more senior Engineers as necessary Experience with Bugzillais a plus....

Solidworks Design Engineer

A Design Engineer with Solidworks experience is needed for a 6 month contract assignment with possible extension for a leading manufacturer of healthcare products in Roswell GA. Please apply asap for this excellent opportunity! The Design Engineer is a member of the Research and Engineering Global Design and Drafting Services. You will be focused on analyzing and creating a plan to re-specify one entire product line, with the potential of more product lines. The opportunity will exist for the incumbent to apply hands-on design, analysis, communication, and collaboration skills. You will participate in the computer aided drafting of product specifications utilized in the manufacturing of company products. You will participate within design-drafting team to meet objectives of the assigned area. Participates within the Manufacturing Support Team to insure that new products and product changes will fit manufacturing processes and fulfill customer needs. This must be accomplished while maintaining excellent customer service. Responsibilities: * Responsible for reviewing numerous medical device product category and structuring product drawings into relevant categories * Responsible for leading and coordinating drawing changes with the team * Responsible for auditing, cleaning and reorganizing EPDM data * Responsible for creating models and drawings using numerous configurations in Solidworks * Responsible for communicating drawing changes with Program manager and Product manager * Provide design and drafting support for both products development and production of health care devices and supplies for hospitals and clinicians. * Preparing and transferring documents and drawings for production....

Field Service Engineer - Maryland

Have you always been drawn to working with automated instruments? Do you thoroughly enjoy fixing and performing maintenance on items in a laboratory setting? If yes, then join our team as a? Field Service Engineer ? Maryland Your Tasks: As a member of the Miltenyi Biotec Service Operation team, you will perform warranty and contract service maintenance, such as reviewing the severity of complex malfunctions, along with determining and/or engaging in corrective actions required to restore systems to full operation in a time sensitive manner. You will also work to resolve customer issues and complaints through utilizing appropriate internal and external resources; acting as a crisis manager when necessary. In addition, you will prepare, update and maintain accurate logs, equipment performance data, service records, and parts usage software. Last, but certainly not least, you will responsibly schedule and perform equipment installation and preventative maintenance. As a result, you will enable the continued optimum instrument performance and success of our company as a whole....

Field Service Engineer - Houston

JOB TITLE: Field Service Engineer, Medical Device POSITIONSUMMARY: The Field ServiceEngineer is responsible for installing, maintaining and troubleshooting XtracExcimer Lasers in medical offices, medical institutions and medical spas withina specific geographic area. Our primaryfocus is in Dermatology. We will providecomprehensive training. ESSENTIAL JOB FUNCTIONS(BUT NOT LIMITED TO): Perform assigned Preventive Maintenance for the Xtrac lasers. Perform installation of Xtrac Lasers for new accounts. Troubleshoot and correct problems with Xtrac lasers in the field. Perform bench repair for Radiancy LHE devices in Radiancy office in Orangeburg NY. Create strong relationship with users of the laser in assigned accounts. ENVIRONMENT ANDCONDITIONS: Work independently in home office and customer offices...

Quality Assurance Engineer

Quality Assurance Engineer Develop, implement and maintain Quality Assurance Engineering programs on assigned areas in Manufacturing, Supplier Management, Process Validation and New Product Introduction. Areas of responsibility may include: Non-conforming product, CAPA, Validation, Risk Analyses, Calibration Systems, Auditing, Statistical Support, Quality Planning, Experimental Protocols, Facilitation of Root Cause analysis and Complaint Investigation. Review, assess and evaluate validation protocols (IQ,OQ,PQ) for compliance to procedures and regulations, statistical validity and approval. Manage process monitoring activities including tracking, data collection and analysis, corrective action, and reporting. Lead continuous improvement activities for the validation program to ensure efficiency, effectiveness and compliance. Supplier Management: Coordinate and participate on supplier audits and technical assessments. Assist purchasing with identification and qualification of suppliers and alternate manufacturing locations. This position requires 3 to 15 years? medical device manufacturing experience . Knowledge of FDA?s QSR and ISO regulations. ASQ Certified Quality Engineer, Lean Manufacturing and/or Six Sigma certification preferred. Excellent interpersonal and communication skills. Working knowledge of Word Processing and Spreadsheet software required (MS Word and Excel knowledge desired). This position requires a B.S. Mechanical Engineering degree, B.S. Biomedical degree, B.S. Materials degree, B.S. Ceramic or Polymer Engineering degree or other technical engineering science degree. Key Words: Manufacturing/Production/Operations - Quality, Engineering, Medical Device ISO-13485, etc. Medical Device, pharmaceutical, consumer products, aerospace, automotive, industries experience. Desired: M.S. Mechanical Engineer, MIT, University of Pennsylvania, Cornell, Harvard, Brown, Duke, Villanova, Drexel, Penn State, Carnegie Mellon, University of Mass, University of Illinois Urbana Champaign, University of Michigan, Purdue University, Virginia Tech, University of Maryland College Park. If interested & you meet the requirements please send a copy of your resume as a word doc attachment to . Steve Moore direct line 484 567 2081. Code: liberty123...

Manager, Visual Inspection Engineer

Sanofi Pasteur, the vaccines division of Sanofi, is a global company that provides more than one billion doses of vaccine each year, making it possible to immunize more than 500 million people across the globe. A world leader in the vaccine industry, Sanofi Pasteur offers the broadest range of vaccines protecting against 20 infectious diseases. The company's heritage, to create vaccines that protect life, dates back more than a century. Every day, the company invests more than one million Euros in research and development. Sanofi, an integrated global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients? needs. Sanofi has core strengths in the field of healthcare with seven growth platforms: diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and the new Genzyme. Manager, Visual Inspection Engineer SME in Visual Inspection for the Swiftwater Site. Provides technical support and/or leadership to all Visual Inspection related subjects for site: Adjustment/tuning automated inspection machines Qualification of automated inspection machine recipes Support the identification of critical process parameters and acceptance criteria for development and validation Training on the application of automated inspection machine configurations to optimize detection of defects in final containers, especially containers having particulates. Technical trouble-shooting and deviation investigation related to Visual Inspection Automated inspection machine equipment specifications, new vendor/equipment selection, and startup of new equipment SME for health authority inspections Stays up to date on latest technical and regulatory trends in the biomedical imaging science, optical engineering and visual inspection arena...

Product Compliance & Safety Engineer - Medical Device - Regulatory

OR1 Product Compliance and Safety Engineer is responsible for providing guidance to the KARL STORZ (KS) product design team(s) regarding safety standards relevant to products being planned and/or developed. This position plays a key role in the establishment and maintenance of product risk analysis documents. DUITES AND RESPONSIBILITIES Responsible for reviewing any Engineering Change Requests which could have an effect on product safety. Interfaces with Safety Testing Houses (like ETL, UL or CSA). Responsible for ensuring that Sterilization and Reprocessing efficacy is established and maintained for new and legacy products. Ensures that documents and reports are generated to fulfill product testing and safety requirements. Assists with other QMS related activities, such as: Supplier Evaluation and Management, Employee Training, Complaint Investigation, CAPA, Continuous Improvement, Cost of Quality Measurement, Environmental Compliance, etc. Assists Quality Systems Manager with ensuring that the established and implemented QMS satisfies ISO 9001:2000, ISO 13485, the 93/42/EEC Medical Device Directive in support of European Operations, as well as other applicable EU directives, the Canadian Medical Device Regulations, and the U.S. FDA cGMP/QSR. Engages in regular and necessary communication with employees at all levels throughout the facility as well as the NAR. Works in close collaboration with European divisions of the KS company to ensure that non U.S. requirements continue to be effectively and efficiently met. Works with various testing agencies during initial product testing, as well as periodic compliance of production units. Provides reporting to location management regarding the current state of post-sale product safety. Regularly advises Local Management, through direct communication and special reports, of significant events (positive or negative) regarding product safety issues. Performs other job-related duties or special projects as assigned...

Systems Engineer - medical device

My client, a industry leader in Healthcare Imaging and IT has an immediate opening in their Rochester corp office for a Systems Engineer. This person will be experienced working with Mechanical, Electrical and Software products. They will work with a multi-disciplined project team on complex medical device designs from the conceptual phase through successful product launch. ? Establish the product requirements, systems level architecture design, and interface design definition by collaborating with cross-functional disciplines within the product development environment. Support the creation of customer requirements. Translate market-driven requirements into technical specifications, and ultimately flow them down into lower level hardware and firmware requirement documents. Conduct product safety analysis and develop design solutions to mitigate risks. Provide technical expertise to support external and internal customers throughout the product life cycle....

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