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 Equipment Repair

LOCAL BIOMEDICAL EQUIPMENT SERVICE COMPANY SEEKS PM AND SERVICE BIOMEDICAL ENGINEER TO MAINTAIN AND REPAIR MEDICAL EQUIPMENT IN HOSPITALS, NURSING HOMES, CLINICS AND OTHER HEALTHCARE FACILITIES MUST HAVE A BACKGROUND IN BIOMEDICAL EQUIPMENT REPAIR, TESTING AND PREVENTIVE MAINTENANCE. BIOMEDICAL EQUIPMENT REPAIR TECHNICIANS (SUPERVISORY POTENTIAL) We Accept Applicants Holding H1B Visas. 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. Requirements Should be customer oriented Have experience servicing a broad variety of medical equipment `including general biomedical, enteral pumps, diagnostic and physical therapy equipment, etc. An Associates or Bachelors degree in biomedical engineering, clinical engineering or electronics (or military training) or related work experience. Note: Training will be provided on equipment with which applicant is not experienced....

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

Biomedical Technician FT Days: 7:30 am to 4 pm The Biomedical Technician is responsible for ensuring the maintenance of all Biomedical equipment throughout the facility as well as implementing processes for the effective and efficient delivery of services for all aspects of medical equipment at the facility. Biomedical Technician...

Japanese/English Fluent Chemical or Biomedical Engineer

Japanese/English Fluent Chemical or Biomedical Engineer Bilingual Japanese and English Fluent Professional with Chemical or Biomedical Engineering background. Assist DC-area law firm to gather information from and categorize Japanese pharmaceutical documents....

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 Electronics Technician

Job is located in Ansley, LA. The BiomedicalElectronics Technician II 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 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 Eng

Biomedical Eng (US-Brazil)(Doral, Florida) report and dev all technical and regulatory needs for production of electroencephalgrahic machinery produced by parent company in Brazil; enhance the company's products, process and infrastructure; use software and math models to design, develop, and test new materials,devices, and equip; daily contact with manufact, qual control, purchasing and marketing depts in Brazil....

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 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

Top Three Skills: Medical Mechanical Engineer Product Development Job Description: *Mechanical or Biomedical Engineer 0-3 years experience. Bring support for Neuromodulation Implantable Neuro System and implantable drug pump devices, used for movement disorder, gastro uro and pain therapies. * Projects require the ability to support design changes that are mechanical in nature. * The key at being successful in this job is the ability to multi-task, work effectively cross functionally, drive projects to closure within specified timelines and be flexible on project assignments. * The engineer will be expected to evaluate existing products and provide design changes that improve manufacturability, quality, reliability, and reduce cost. * The engineer will need to work effectively with Medtronic Neuromodulation Manufacturing, Supply Management, Quality, Reliability, and Regulatory functions to qualify and implement design changes. Perform detailed design analysis on critical design elements. Participate, support or potentially lead corrective action teams to resolve quality issues (CAPA process. Qualifications: REQUIREMENTS: * BS in Mechanical Engineering (BSME) with some relevant engineering experience in design, development, manufacturing or quality. (0-3 years experience) * Experience in the medical industry strongly desired. Understanding of regulatory requirements and processes strongly desired (FDA preferred). * Proven ability to work independently with minimal oversight within product development process and complete tasks on time. * Skills and competencies include: good written and oral communication skills, ability to effectively lead projects or project elements in a cross functional team environment, strong presentation skills, strong technical writings skills, thrives on variety and flexible project assignments, understand manufacturing processes and quality, \ computer competency, problem solving skills, time managements skills, strong team work and multi-tasking skills. * Knowledge and experience using DFSS/Six Sigma, CAD systems (Pro/E, SolidWorks) and FEA preferred. Performance Expectations: Communicate design concepts and technical plans effectively,Lead troubleshooting activities of design issues,Perform tolerance analysis of designs and stack-up analysis,Write detailed protocols and reports,Review drawings, create ECO's 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...

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...

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....

Manufacturing Engineer / Automation Engineer

Manufacturing Engineer ? Medical Device *3rd PARTY RECRUITER - CONFIDENTIAL My client is looking for several top Senior Manufacturing Engineers (2-10 years exp) with a Mechanical Engineer, Biomedical Engineering, or Electrical Engineering degree. This is a strong player in the Medical Device industry looking to bring their new products to market through added manufacturing and increased product lines. They are looking for a strong mechanical aptitude as well as a commanding technical knowledge. This position will be requiring ?concept to manufacturing;" demanding innovative problem solving ability. They need everything from TOP BS/MS degree students to several years experience in design of intricate, complex component devices. The candidate will be need hands on" ability and experience with the verification and validation of product designs. They are looking for management ready applicants; provided their continuous expansion and opportunity to move up. Salary is among Industry Elite; along with a TIER 1 benefits package/ Relocation Assistance...

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...

Radiological Engineer

RadAmerica II, LLC has a radiological engineer position available in the Baltimore/DC region. The incumbent will perform first call service response on RadAmerica equipment. Other job functions include identifying equipment malfunctions and determining appropriate corrective action and identifying operator errors and providing instructions/feedback to operators. The position will also perform basic equipment repairs, provide follow -up and suggest resolutions for Quality Control (QC) issues, maintain parts inventory, identify and resolve systems hardware and software problems, provide clinical systems network support and development, compile and deliver service reports as requested, evaluates QC test results on specified diagnostic imaging equipment. The position may assists with commissioning of new equipment and will coordinates and oversees activities between vendors and the department. Desired Skills & Experience...

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...

Clinical Engineering Manager I

Hospital Site Biomedical Manager, Responsible for Full P&L, Fully Responsible for Team, Close Customer Interface, Full Benefits, Low Travel, Extensive Training Programs. The Clinical Engineering Manager I leads clinical engineering initiatives to provide superior customer service and operational efficiency by managing the execution of the TriMedx Medical Equipment Management Plan (MEMP). This position manages operations on a day-to-day basis, collaborates and maintains positive relationships with customers, works to develop colleagues, and provides a communication channel between hospital executives and the TriMedx Central Office. The Clinical Engineering Manager I also directs Joint Commission inspections and ensures that TriMedx services are in compliance with regulatory standards. This position includes a hands-on service component in general biomedical support....

Field Service Engineer

Job Summary: 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. Job Responsibilities : Provide on site system installation, maintenance and repair within an assigned geographical area or as required. Independently conduct repairs, upgrades, preventative maintenance, and system installations and supports in-house operations as required. Ensure timely, professional, and effective response to customer service needs to maintain a high level of customer satisfaction. Submit required field based documentation in a timely and accurate manner such as Customer Database Reports, Expense Reports, SEG Calendar Entries, Installation Checklists, Countermeasure forms and Quality issue reporting in accordance with Managements directives and Olympus corporate guidelines Establish and maintain open communication with management and other field staff members and product management throughout the organization to help resolve all undefined or ongoing product or customer support problems. Responsible conducting all travel arrangements as per corporate financial policy Assist other Field Service Engineers and SEG Sales Representatives with product installations, trade shows, demonstrations and other events as required. Proactively works within the region to support key accounts and other customers as required Responsible for all service parts requested by or assigned to the FSE. Manage inventory in accordance with established policy and procedures. Perform other related duties as assigned. Requirements...

Quality Engineer

Quality Engineer About Our Company: With more than 25,000 employees globally, ZEISS is one of the leaders in the optical and optoelectronic industry. As part of the Medical Technology business group you will work on simplifying clinical and office workflows through innovative solutions. Products from ZEISS help doctors to diagnose and treat more efficiently and reliably, and therefore enhance their patients' quality of life. Carl Zeiss Meditec AG, recently acquired, AAREN Scientific, a US-based manufacturer of intraocular optical lenses (IOLs) and ophthalmic surgical products for cataract surgery. AAREN Scientific is located in Ontario, California and seeks experienced, highly motivated individuals to support the growth and demands within various departments and functions. Within our QM/QC department we need; Quality Engineering Job Summary: This individual will provide Quality support for Validations, IQ/OQ and PQs creation and Quality process development and documentation necessary to integrate and maintain products into the production systems. Plans and coordinates activities to support new product introductions and process improvements by performing the following duties. ESSENTIAL DUTIES AND RESPONSIBILITIES : Other duties may be assigned. Document implementation of QM/QC group (SOP?s; ETE?s). Reviews records; Writes procedures for QM/QC group. Support QM/QC document control function Responsible for QM/QC validations, IQ/OQ/PQs, testing and other assigned QM/QC functions Responsible for regulatory agency audit support, QSR maintenance and improvements and creating improving QM/QC documentation Create new documents in-QM/QC implementation Development/optimization of QM/QC processes to improve product quality Determines quality improvement parameters by identifying statistical methods relevant to manufacturing processes. Establishes statistical confidence by identifying sample size and acceptable error; determining levels of confidence. Establishes statistical reliability by using mean time before failure, weibull 3-parameter distribution, reliability modeling, and reliability demonstration tests. Develops experiments by applying full and fractional factorial techniques. Develops sampling plans by applying attribute, variable, and sequential sampling methods. Maintains statistical process controls by applying demerit/unit, zone charting, x2 charts for distributions and individual-medial/range for multi-stream processes Analyzes data by completing hypothesis, normal distribution, and process capability analysis tests. Prepares reports by collecting, analyzing, and summarizing data; making recommendations. Maintains professional and technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks; benchmarking state-of-the-art practices; participating in professional societies; maintaining ASQ American Society of Quality Control certified quality engineer qualification. Contributes to team effort by accomplishing related results as needed. Quality Engineer...

Product Development Engineer

Pioneering Therapies, Transforming Lives. What does it mean to be part of the Thoratec Team? It means working in a fast-paced environment that inspires you. It means collaborating on projects that literally save patients' lives. We have an incredible opportunity for a Product Development Engineer to work with our innovative R&D team in Sunnyvale, CA. The Product Development Engineer will be responsible for designing an innovative catheter based device for the new PHP program. This position requires a strong mechanical design background and hands-on involvement in order to efficiently prototype and evaluate design concepts. The Product Development Engineer will take the lead to ensure that the device, including materials, components, processes, and acceptance activities, are properly documented. This position may require defining project activities and leading others in completing those activities. The Product Development Engineer will act as a mentor for less experienced staff, leading problem solving activities and developing intellectual property. Responsibilities: This position is responsible for, but not limited to, the following: Designs innovative catheter based medical device which meets user needs using 3D modeling and stress analysis tools (includes working on electrical interfaces between catheter & console) Develops processes required to fabricate the device. Designs tools/ fixtures required to assist in device manufacturing. Creates Work Instruction documentation which describes manufacturing of the device. Leads a product development team in developing the key features for the Heartmate PHP. Uses results of reliability and performance testing to perform failure analysis / corrective action activities and design modifications. Determines design options which creates device that meets performance goals within cost constraints. Participates in cross functional activities (i.e. risk analysis, supplier development, CAPA). Creates intellectual property....

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...

Test Systems Engineer

Job Classification: Full-Time Regular Connect confidentially with MRIGlobalMedDevice at: Our client is a well-funded, early stage global med device company who is expanding their team. This company is on the threshold of something very big - this is a rare ground floor opportunity you won?t see often - huge market for their device. Wear a lot of hats in an environment of high motivation & initiative, focused on collaboration, teamwork , communication - work with people who are very excited to be there. Company offers every employee stock options so everyone has a vested interest in their overall success. Excellent compensation! Essential job responsibilities include, but are not limited to: Create equipment and software specifications for testing apparatus from product specifications and performance requirements Design analog and digital electronic circuits and mechanical hardware for automated test systems. Program test systems to meet the intended requirement by designing and developing software requirements and testing applications for automated testing equipment to be used for integrating and testing of electromechanical medical devices....

Manufacturing Engineer

The Manufacturing Engineer will be responsible for supporting the scale-up and optimization of current and new manufacturing processes within the Manufacturing Group. This person will be involved in developing, qualifying, validating, and documenting manufacturing systems, equipment, and processes for new products being transferred from product development. The manufacturing engineer will also be responsible for optimizing and troubleshooting current manufacturing procedures. The job requires the individual to be a team player with the ability to function well in a challenging and fast paced product development environment as well as being able to work independently with little to no supervision. The candidate must be enthusiastic, positive, even tempered, and possess strong skills in areas of dependability, interpersonal relationships, communication, organization, and flexibility. Familiarity with ISO requirements, FDA Regulations, and cGMP?s a plus. Primary Responsibilities Evaluates and optimizes existing manufacturing processes. Evaluates new manufacturing equipment, analytical equipment, and/or processes for use in manufacturing. Performs, oversees, and documents optimization experiments, tests, and data collection efforts to validate new manufacturing equipment and procedures. Performs IQ/OQ/PQ?s on new manufacturing equipment. Demonstrates effective writing skills for drafting SOP?s, Oper. & Maint. Procedures, protocols, reports, and other manufacturing related documentation. Design/development packaging for new products being introduced to market. Designs manufacturing systems and equipment for new products. Evaluates current production capabilities and recommends improvements. Demonstrates and applies a thorough understanding of engineering and scientific principles related to medical device manufacturing. Provides technical support to product development with regard to manufacturing process design, transfer, and validation. Interfaces with Quality Assurance/Quality Control to assure products and processes comply with all required regulations. Secondary Responsibilities Maintains up to date knowledge with respect to relevant state-of-the-art technology, equipment, and/or systems. Maintains laboratory equipment to document process development and optimization. Performs miscellaneous job-related duties as assigned....

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....

Software Engineer

This position is open as of 10/22/2014. 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....

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....

Sr. Quality Engineer - Injection Molding

Summary Career Opportunity Client Details A medical component manufacturer in the Pasadena area is seeking a Senior Quality Engineer with experience in injection molding manufacturing operations or equivalent for a permanent hire opportunity. Description Supports new product development and product maintenance through the application of quality engineering disciplines and the use of the site quality system and quality system regulations for medical devices Champions site quality initiatives and participates in the development of site quality plan Leads and mentors cross-functional quality engineering project initiatives Works with Quality Assurance Manager in providing back-up supervision of Quality Specialists and Quality Leads Handles multiple projects and tasks, from product inception through product launch and maintenance Helps establish manufacturing inspection, sampling and statistical process control methods, and procedures to assure quality of manufactured products Assures compliance to in-house and external specifications and standards Identifies and highlights quality issues by providing input to drive corrective actions to problems identified. Performs / leads root cause analysis to determine corrective action(s), as necessary. Interfaces with manufacturing in identifying and correcting quality issues for new and existing product lines. Assists with the investigation of root cause and determination of corrective and preventive actions Works continuous improvement projects from beginning to end Works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors Profile Bachelor of Science degree in Engineering or related field Preferably: Certified Quality Engineer (CQE), Certified Quality Auditor (CQA) and/or Regulatory Assurance Certification (RAC) 5+ years' experience in injection molding manufacturing operations or equivalent 5+ years quality engineering experience in the medical device industry Project management and presentation skills Certification in Quality Engineering, Biomedical Auditing, or equivalent Experience in a metric driven culture Demonstrated knowledge in Quality System/Good Manufacturing Practices. Demonstrated competency in basic statistics, data analysis, technical writing, continuous process improvement, including lean, six sigma, and validations Job Offer Compensation + benefits...

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....

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....

Systems Engineer - Medical device

My client, a leader in Imaging and medical device, has an immediate opening for a Systems Engineer in their Rochester Corp office. This person will have experience working with Mechanical, Electrical and Software products. The Systems Engineer will work with a multi-disciplined project team on complex medical device designs from the conceptual phase through successful product launch. This position is in Rochester, NY. Generous relo package provided. ROLE: ? 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. ? Collaborate with department function peers and Project Managers to create integrated technical designs and project schedules. Serve as the system subject matter expert in one or more technology disciplines to ensure that mechanical, electrical, and software subsystems function reliably as one integrated system. ? Facilitate architectural and design decisions to ensure on-time delivery of quality products, within cost, schedule, and performance constraints. ? Drive hardware and firmware development through the product lifecycle within a stage/phase gate, utilizing risk management techniques and automated requirements traceability tools....

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...

Senior Product Development Engineer

Overview: Bard Davol Inc., a subsidiary of C. R. Bard, Inc., located in Rhode Island, is a leading developer, manufacturer, and marketer of innovative, life-enhancing medical technologies. We focus our business on key surgical specialties, including Soft Tissue Repair, Surgical Fixation, Biomaterials and Orthopedic/Wound Management Irrigation. Our company has a strong tradition of developing our employees to learn, grow and excel. We are continually building our team with qualified, team oriented individuals to enhance the success of our company. Davol headquarters is situated in a central location, surrounded by a scenic coastline with easy access to T.F. Green Airport, AMTRAK Train Stations and Route 95, a major highway connecting to Providence, Connecticut, Boston and New York City within a short amount of time. Summary of Position with General Responsibilities: This position is responsible for the technical aspects of design and development of new and improved implantable medical devices from initial concept through commercialization and includes evaluating designs through testing. The candidate that fulfills this role will be an active team member and cross-functional collaborator on new product development and product enhancement project teams for implantable medical devices. Essential Job Functions: Develops new technology, products, materials, processes, or equipment with minimal supervision. Independently, or as a member of a team, develops, and executes plans for a major segment of complex projects. Compiles and analyzes operational, test, and research data to establish technical specifications for designing or modifying products, processes, and materials. Innovate, design, develop, optimize and implement processes, procedures, tooling and equipment for new products with specific emphasis on design for manufacturability. Consistently generates innovative and unique solutions to market needs and submits idea disclosures. Work is expected to result in the development of new or refined products, processes or equipment. Successfully completes complex engineering work in one or more of the following: technology development, product design and development, testing of materials or products, preparation of specifications, process study, research investigation (animal studies), and/or report preparation. Selects techniques to solve complex problems and make sound design recommendations. Summarizes, analyzes, and draws conclusions from complex test results. Designs and prepares complex reports to communicate results to technical community. Designs and coordinates complex engineering tests and experiments. Assesses the feasibility and soundness of proposed engineering evaluation tests, products or equipment. Interfaces with Physicians/Cath Lab personnel to obtain feedback on concepts and performance of new devices. Translates customer needs into product requirements and design specifications. Responsible for engineering documentation. Works cooperatively with quality, manufacturing, regulatory, clinical, and marketing on complex projects to ensure project success and identify product performance requirements. May train and/or provide work direction to technicians and entry-level engineers. Demonstrates PDP/TPD system knowledge through delivery of high quality and high impact deliverables. Ensure adequate engineering studies, design verifications, and process validations are conducted such that well developed products are introduced into manufacturing. Write, execute and review validation protocols and reports where appropriate. Ensure documentation is completed to meet quality system requirements. Conduct test method development as required by project teams. Stay current with and ensure appropriate compliance with SOP?s on all projects. Provide support as required to safety, ISO, FDA, corporate and internal audits. Special projects as assigned....

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...

Sr. New Product Development Engineer - Medical Devices

Product Development Engineer - Medical Devices Global leader in the development and production of Class II and Class III medical devices seeks a Product Development Engineer to join an R&D team working to develop new medical devices. This highly regarded, global company is located in the Northern Chesapeake Bay area of NE Maryland, about an hour from Philadelphia. The Product Development Engineer will: Lead the design, fabrication, development, installation, validation, and qualification of products, processes or equipment. This could include feasibility studies, designing & implementing evaluations (FAT?s, SAT?s) and providing technical input for justification of project and equipment. Manage NPD projects from concept through manufacturing Manage SOP?s and for providing training to ensure proper operation of the equipment. Coordinate and executes the Design for Excellence (DFX) aspect of the processes and the transfer to the manufacturing engineering group and the production floor. Work in a technical leadership role on a large project to lead and implement the technical aspects in coordination with other departments, prototype fabrication and/or testing. This could include planning and scheduling technical activities, coordinating technical resources, and preparing proper documentation. Develop and execute projects in new product development process in full compliance with all design control, quality, and company regulations and national and international regulatory body requirements. This could include the understanding of change control, validation, documentation practices, process control and design control requirements....

Director of Development, Engineering

Director of Development, Engineering The Director of Development (Major Gift Officer) will work in partnership with the School of Engineering and the Rutgers Foundation to increase major gift commitments from individuals and contribute to the successful completion of the School?s capital campaign. Under the leadership of Dean Thomas N. Farris, who joined Rutgers in 2009, the School of Engineering has grown in size and stature, and is pursuing strategic initiatives to further enhance its academic programs, professional opportunities, and student experience. Responsibilities: The Director will be required to develop and execute a fundraising plan and will work collaboratively with the dean, department chairs, center directors and faculty to secure support for School priorities. The focus is on major gift fundraising, and includes frontline responsibility for a portfolio of 75-100 prospects rated for gifts of $100,000 or above that are in various stages of identification, qualification, cultivation, solicitation, and stewardship. This individual will also coordinate with colleagues in Principal and Major Gifts, Corporate and Foundations Relations, Gift Planning, and other departments at the Rutgers University Foundation to maximize philanthropic support for the School of Engineering. The Director will be responsible for an average of 15-20 face-to-face donor/prospect visits per month and will strategically orchestrate meetings and other interactions between the Dean, faculty and prospective donors. The Director will also maximize travel of the Dean, and faculty, where helpful, to engage with alumni and donors. The Director will prepare briefings for the Dean, board members, and other University leaders for visits with prospects, as well as written communications and presentation materials as required. The Director is responsible for accurate inputting of records pertaining to visits, contacts and solicitations and update of all relevant donor/prospect information and must have the ability to translate technical and basic research projects into fundable opportunities; strong proposal writing skills are required. The Director will be expected to have an appreciation for new technologies and their role in society. A background in engineering or the sciences and/or familiarity with new developments in engineering is desirable. A creative and energetic approach to donor solicitation and the promotion of New Jersey?s premiere School of Engineering is required. An understanding of higher education, the role of a public research university, and the ability to translate the School?s priorities to external constituents and create interest in academic programs is key. About Rutgers Created in 1973, the Rutgers University Foundation advances Rutgers' pursuit of excellence in education, research, and public service. The Foundation provides the bridge between donors and the schools, programs, faculty, and students that make up the University. The Foundation helps to match caring people with satisfying and meaningful opportunities to make gifts that have an impact on Rutgers. Founded in 1766, Rutgers is the eighth oldest institution of higher education in the nation. Today, Rutgers, a member of the Association of American Universities, is New Jersey's premier public research institution and flagship state university. More than 100 majors offer students vast opportunities. On July 1, 2014, Rutgers University joined The Big Ten Conference of world-class universities whose member institutions share a common mission of research, graduate, professional and undergraduate teaching and public service. The Foundation is a 501(c) (3) tax-exempt organization. Our sole mission is to support Rutgers University. Established in 1864, the School of Engineering at Rutgers, is home to educational opportunity and innovation, pursuing work of enormous relevance to society and the economy through world-class research and important industry partnerships. With seven departments representing key engineering disciplines and renowned research centers, the School of Engineering enrolls 4,000 undergraduate and graduate students, including doctoral students, and generates more than $60 million in research expenditures annually. Whether through sustainability, manufacturing, the biomedical sciences, transportation or energy, Rutgers Engineers, now more than 20,000 strong, are addressing some of the most important issues in our society and identifying new ways to solve tomorrow?s problems....

Quality Engineer II - Supplier Quality

The Supplier Quality Engineer will be responsible for preventing discrepancies through the proper selection, appraisal, monitoring, improvement, education and correction of our most critical partnerships, our suppliers. Responsibilities: - Preventing supplier related discrepancies - Mitigating supplier risks- Monitoring supplier's performance - Correcting supplier deficiencies - Partnering with high quality suppliers. Supplier Quality works closely with Product Teams, Suppliers, Research and Development and Receiving Inspection to ensure: ? Strategic Supplier Selection? Supplier Certification? Supplier Performance Monitoring (supplier report cards)? Supplier Improvement / Enhancements (Capability studies, Gage R&R, Supplier Action Requests)? New Product Support (Process validation, Inspection Planning, Special Inspection Support)? Supplier Risk Mitigation and Controls (Functional Gaging, Supplier Surveys New Supplier Qualification (Supplier Audits)....

Field Service Engineer - Medical Electronics - Lasers

Field Service Engineer - Medical Electronics / Optical This position offers full benefits, job stability, a positive working environment, and a company car. ? The position will have you covering a territory that includes TX, OK, AR, LA, and KS . ? This is a home-based role that includes some overnight travel and will never have you traveling on the weekends. ? The company/ ? position offers a very positive ?wor k-life" balance. ? If you are qualified for the position and interested in pursuing it, please answer the questions posed at the end of the description and send me your Word formatted resume. ? Responsibilities ? Performs preventive and corrective maintenance as directed and required. ? ? Performs the administrative duties associated with the job, including expense reports, time cards, parts requisitions, installation reports, service reports, and other reporting duties from time to time assigned. ? Assures that all paperwork is completed neatly, accurately and submitted promptly. ? ? Responsible for the maintenance of assigned tools, test equipment and tech spares. ? ? Performs on-call standby duty and travel as required. ? Must be prepared to work occasional overtime and odd hours, when directed. ? ? Responsible for developing and maintaining good customer relations. ? ? Travel will almost never include weekends and will mostly involve day trips (limited travel overnight)...

Mechanical Test Lab Engineer

MED Institute, Inc. is currently accepting applications for a Mechanical Test Lab Engineer to become a part of our growing Nonclinical team. Responsibilities The three primary roles of this position include: Feasibility testing to support the product development of medical devices; Design verification testing to support device regulatory approval; and Post-market device evaluation to support clinical and/or marketing activities. This position requires a technically sound engineer capable of challenging medical devices through accelerated fatigue, corrosion, electrosurgical, simulative use, and basic mechanical properties medical device testing. In addition to developing and validating test methods and conducting tests compliant with various international regulatory agencies, this person will also be responsible for the maintenance of well-controlled documentation, including written protocols, data forms, and laboratory notebooks. Other activities, but not limited to, may include test matrix development, standard committee involvement, and research related to defining clinically relevant test conditions. Essential Qualifications M.S. in Mechanical/Biomedical Engineering required. A hard-working, enthusiastic, detail-oriented person with strong written and verbal communication skills, recordkeeping and interpersonal skills is needed. Will be working in a team setting and must be willing to be trained....

Manufacturing Process Engineer

Manufacturing Process Engineer Duration: 6 month(s) 7000 Central Ave NE Minneapolis MN 55432...

Clinical Engineer Linear Accelerator Nuclear Med.

RESPONSIBILITIES: Our client is seeking a Clinical Engineer Linear Accelerator Nuclear Med. for their Atlanta, GA location. This is a great opportunity for a full time position with this company. This position is required to/ responsible for: Perform installations, repairs, and maintenance tasks on biomedical or electromedical equipment such medical imaging machines, medical laboratory equipment, or specific medical devices. * Inspect, test and adjust malfunctioning components and parts. Keep records of system problems and issues....

Project Manager

A Project Manager provides leadership to the task force to ensure timely completion of all activities and deliverables during the various stages of multidisciplinary design projects. The project manager is responsible for the technical integrity of the design deliverables as well as management of the project scope of work, project engineering budget, design schedule and client relation management. The projects may vary in size and nature, but are mainly in the area of small to medium capitals works, plant engineering and improvements to mill or plant operations. Besides project execution activities, the project manager takes leadership in the development of competitive proposals which outline and define project scope of work, design deliverables, engineering effort-hour and engineering cost estimates....

Mechanical Engineering Mgr

The Company: Founded in 1969, Flextronics International Limited has grown into a $30 billion business and become one of the world?s leading Electronics Manufacturing Services (EMS) providers that offers complete design, engineering, and manufacturing services to aerospace, automotive, computing, consumer digital, industrial, infrastructure, medical and mobile OEM customers. With a network of facilities in 33 countries and an employee base of over a 230,000 strong, Flextronics helps customers design, build, ship, and service electronics products worldwide. Purpose: Responsible for leading a team of Mechanical Engineering employees in order to ensure that delivery targets are met. Principle Accountabilities/Duties: Provide technical leadership to the Mechanical Engineering Teams (including industrial design) in the design and development of mechanical systems and components for new and existing medical disposables, electro-mechanical medical devices or medical equipments. Oversee ME resources budgeting, allocation, review and approval. Manage internal and external ME resources to meet the design, build, test and manufacturing criteria Track projects and progress through regular reviews. Identify potential technical problems and implement timely corrective actions to ensure that commitments are met. Participate in product architecture and feasibility technical reviews. Provide assistance and guidance in the development of product designs from proposal to delivery. Ensure application of strong analytical and problem solving methodologies Provide technical support to customer and Sales team. Implement appropriate HR Strategies and actions to recruit and retain a qualified and motivated workforce...

Business Analyst - LIMS

Job Summary for the Business Analyst: Our client, a growing medical research organization, is looking for experienced business analysts who are looking for an opportunity to work with an innovative team. The Business Analyst will work with a close-knit team that is implementing an enterprise Laboratory Information Management System in an organization working to find solutions to empower the global biomedical community in their pursuit of advancing human health. The Business Analyst will have experience in Laboratory Information Management Systems to contribute to a multi-year implementation of an enterprise LIMS system across several dozen laboratories at multiple sites in the organization. The successful candidate will be part of the LIMS implementation team and will work closely with laboratory personnel to define and document configuration of user interfaces, map process and workflow, provide data management, and define systems integrations to meet the rapidly growing and highly integrated needs of laboratory service groups. Responsibilities of the Business Analyst: Lead functional and technical requirements development Assess and validate solution options against requirements Participate in design, configuration and customization of solutions Author "As Is and "To Be workflows, requirements, use cases, and other relevant documentation...

Development Specialist

For more than 100 years, Praxair has taken something as fundamental as air and turned it in to ways to make plants operate cleaner and more productive, food taste better, breathing easier and manufacturing processes more efficient ? in short, to make all our lives better. Praxair is a Fortune 250 company with products and technology that serve more than 20 different industries. We?re one of the world?s largest industrial gases businesses and you see our products and services at work every day, often without realizing it. As a growing company, Praxair is always looking for talented, energetic and ambitious people to join our high-performing team of 27,000 employees working in more than 50 countries. Serving as a vital member of Praxair's Healthcare R&D Global Market Network, the successful candidate will develop new programs for gas applications, devices, and services in the healthcare field, primarily but not exclusively in the areas of respiratory care, cryobiology, and medical gases applications. Key accountabilities include: ? Leading R&D projects from proof of concept to full commercialization ? Coordination of research projects including planning and designing experiments and evaluating results ? Providing regular updates and recommendations to senior executive management ? Driving and directing pilot and beta evaluations ? Building relationships with global marketing organizations, industry, suppliers, government entities, hospitals and universities ? Resource planning for development funding approval The successful candidate should exhibit technical excellence and be able to champion new ideas and technology within Praxair. To do this effectively, the candidate needs to demonstrate leadership capability, strong verbal and written communication skills, a team-oriented focus, and an ability to find innovative technical solutions. Where your talent makes an impact All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status....

QA Engineer - Design Verification Lab

SHL GROUP We have an immediate opening for a QA Engineer for the Design Verification Lab; at our Deerfield Beach, Florida facility. Our company provides design verification, final assembly, labeling and packaging services of drug delivery devices, to the pharmaceutical and biotechnology industries and soon clinical fill finish capabilities. Scientists and Engineers work closely with our partners to continuously create and introduce innovative, patient centric, solutions to enhance patient compliance and user experiences. Dedicated project managers work closely with their counterparts at the partner company to develop and maintain program timelines in line with the strategic and business needs of our partners. In addition, for those partners who wish to have SHL handle the final assembly process, SHL Pharma offers robust final assembly and labeling capabilities that enable our partners to improve speed to market and reduce the number of parties involved as well as have one clear point of responsibility. We are looking for a Quality Assurance Engineer to work in a highly motivated group within our R&D facility supporting the Quality aspect of Design Verification . This position will be responsible for planning, monitoring and implementing quality assurance programs for Design Verification by performing the following duties: Position Description: Develops and maintains Quality Assurance and Risk Management programs, procedures, and documentation for the Design Verification lab. Performs root cause analysis of non-conformance findings and will be a key member of a cross functional team that will conduct ?out of specification investigations". Assigns and ensures completion of corrective and preventive actions. Assists in conducting and documenting process and system audits using cGMP, ISO and company requirements. Leads supplier audit efforts including creating Quality Agreements with suppliers and customers. Support production engineering, quality control and project management in Design Verification efforts Desired Skills: Preferred B.E. in Biomedical Engineering/Mechanical Engineering or any relevant branch of study, but not required. Candidate must have a minimum of three to five (3-5) years? experience directly related to Qualification / Validation with Design Verification labs within a pharmaceutical environment. Experience within the medical device industry is a plus. Candidate must be familiar with current Design Verification practices and guidelines including those required / outlined by the FDA, ISO and ASTM. Knowledge of Good Manufacturing Practices & Good Documentation Practices Proficient in the use of Microsoft Excel and Microsoft Word We have an excellent benefits package and offer a salary that is based on experience and accomplishments. If you possess the required experience and qualifications and want the challenge of growing with our company then submit your resume in confidence to our Human Resources Department at...

Test Engineer

The test engineer will be performing a variety of tests on Software, Firmware, and Hardware. They will initially be brought on to test the GUI for their Cardiovascular Navigation application. They will not be programming but should have a baseline knowledge of object oriented programming. After the initial project they will be exposed to a variety of different testing techniques and testing tools. They will also be performing basic tests to hardware (Medical Devices) and Firmware (Interfaces for the Hardware)....

Aseptic Cleanroom Production Technician

Immediate Opening for an Aseptic Cleanroom Production Technician in Denver, Colorado In partnership with an international biotechnology/medical device company committed to developing, producing & marketing advanced, effective & safe products & systems for assisted reproduction, Kelly Scientific Resources in Denver, Colorado is pleased to announce a contract-to-hire opening for a Production Technician for our Englewood, Colorado location. The Production Technician will be responsible for production of IVF media, aseptic filling, weighing, labeling/packaging, and cleaning/sterilization. Work takes place fully gowned in cleanrooms and is performed according to GMP and ISO guidelines. Primary Duties: Work fully gowned in cleanrooms to produce IVF media, including but not limited to weighing, formulation, labeling/sleeving, packing, aseptic filling, bottle washing/sterilizing, cleaning, and documentation Performs general troubleshooting of equipment while maintaining production schedule Sets-up and prepares equipment for ongoing operations Operates various processing equipment (i.e. dry heat sterilizer, autoclave, filling line, sleeving, labeling, packaging, etc.) Provides support to validation efforts for new products, equipment and processes Follows instructions and procedures for completion of tasks Writes and reviews documents related to manufacturing and quality processes Complies with manufacturing process Successful Attributes: Attention to detail; strong analytical, and organizational skills Ability to problem solve; ability to foresee and prevent problems Ability to manage multiple priorities and advance several task Strong verbal and written communication skills Good interpersonal skills; team oriented Basic computer skills, including word processing and spreadsheets Excellent manual dexterity Standing gowned in cleanrooms for the majority of work day Ability to lift 50 lbs Background: High School diploma or GED, Bachelor's degree not required Must have a minimum two (2) years of experience working in medical device manufacturing or related field Experience working in Cleanrooms/GMP aseptic production environment/ISO facility preferred The ideal candidate will have a background in a GMP setting and be able to lift up to 50lbs on occasion and be in a class B sterile environment for long periods of time. Specifically, this position will require that the employee be gowned in cleanroom socks, coveralls, gloves, hairnet, facemask, (beard cover), sterile coveralls, sterile boot covers, sterile hood, and a second pair of gloves daily. Employees spend up to 7 hours a day in this gowning working in a cleanroom environment. Requirements Include: ? High School diploma or GED. Bachelor's degree not required ? Must have a minimum two (2) years of experience working in medical device manufacturing or related field ? Experience working in Cleanrooms/GMP aseptic production environment/ISO facility preferred If you meet these requirements, please apply online at www.kellyservices.com. While we appreciate the interest of all, we will only be contacting those that meet the requirements listed above. No phone calls please, local candidates only. Kelly Scientific Resources® has grown into a $300 million global business as the scientific business unit of Kelly Services. We employ more than 700 clinical research professionals and 4,500 scientists on an average workday on a temporary, project and full-time basis in a broad spectrum of industries and disciplines. KSR has more than 100 locations in North America, Europe and the Pacific Rim. 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. 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....

Medical Imaging Service Engineer

We are seeking a Medical Imaging Service Engineer for a healthcare facility in the Meridian, MS area. This position will be responsible for the repair, and calibration of medical diagnostic imaging equipment. The technician will respond to service calls to perform repair/preventative maintenance on medical imaging equipment, while ensuring a safe operation and effective performance of medical equipment by conducting approved programs for quality control and assurance. Maintaining operation knowledge of medical devices, measuring devices, and knowledge of manufacturer?s repair manuals, troubleshooting techniques, and preventive-maintenance schedules is also necessary for the Service Engineer as well as documenting repair action and submitting reports/paperwork in a timely manner. The engineer will ensure proper care of tools and other related and assigned equipment and share on-call responsibilities. They will need to demonstrate and explain correct operation of equipment to medical personnel. We offer an extremely competitive salary and benefits package along with the philosophy which supports your development and recognizes your achievements. We are an Affirmative Action / Equal Opportunity Employer providing a Drug Free Workplace....

Advance Vehicle Engineer

Job Description Compensation: Competitive Sizzle about job: A great opportunity to work for a large OEM If you are an experienced Automotive Advance Vehicle Engineer looking for a position with a leading automotive company, Bartech can help! We are a leading staffing firm and our clients include some of the nation?s biggest automotive OEMs and Tier 1 automotive suppliers. Our clients have a need for an Automotive Advance Vehicle Engineer. This is a contract position; however it is not uncommon for assignments to transition into permanent positions with our client companies. If you have the background we are looking for, and you are interested in an opportunity to get your foot in the door with a Fortune 100 automotive company, we want to talk with you! Automotive Advance Vehicle Engineer Job Responsibilities Your specific duties as an Automotive Advance Vehicle Engineer will include: Designs and develops new vehicles which will meet future regulatory requirements and customer competitive requirements. A qualified candidate will be responsible for the total vehicle packaging. The candidate will identify and resolve adaptation and packaging issues as the vehicle moves toward production. They will lead cross functional team meetings working with Systems & Components, Advance Manufacturing, Service, etc. to ensure that the solutions are optimized for all stages of the vehicle's life....

Technical Writer / Engineer Intern

Your Employment Solutions, a leader in the staffing industry, has been helping people find good jobs in Utah since 1995. We currently have an excellent opportunity for an engineer intern with one of our important clients. This is a contract project for 6-12 months. JOB DESCRIPTION: The technical writer will support projects that focus on cost reductions, process improvements, product quality and other patient issues as necessary for existing product lines. JOB DUTIES/ACTIVITIES INCLUDE: Under the guide and supervision of the Central GMO-NA Engineering Manager, support efforts for projects leading to product realization (concept through release) to achieve department goals and objectives. Apply FDA/ISO Design Control regulations to product development. Effectively lead cross-functional teams on product development and manufacturing problem-solving efforts, to execute projects with clear deliverables in a timely manner. Interface regularly with vendors/consultants. Self-motivate to improve knowledge related to projects by continuous assessment of current publications. Provide technical support to other departments. Hands-on involvement with fabrication and processing. Maintain good documentation practices for all data forms, protocols, engineering and feasibility reports, and laboratory notebooks. Write SOP?s and perform validations on test methods. Other duties as assigned....

SALES ENGINEER

Sales Representative Murzan, Inc. is an engineering company that develops and manufactures pumps and process equipment for food, meat & poultry, pharmaceutical, beverage, cosmetic, and biomedical industries located in Norcross GA Seeking for its outside sales someone with experience in sales in any of the following industries: food, beverage, poultry, cosmetic, and/or pharmaceutical....

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