Biomedical Engineering Career Careers in the United States

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BIOMEDICAL ENGINEER TECHNICIAL

There is an opening in the BIOMEDICAL DEPARTMENT for a BIOMEDICAL ENGINEER TECHNICIAL. JOB SUMMARY: Performs detailed repair and periodic maintenance on complex electronic and electromechanical systems, in-service programs and inventory control of hospital medical equipment. Provides technical support to hospital staff and will act as a liaison between the hospital and vendors....

Biomedical Technician (BMET)

BIOMEDICAL ENGINEERING TECHNICIAN (BMET) (General Medical Equipment) STATEMENT OF WORK 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 medical equipment (see specifics below). Finds causes of failures of assigned equipment and reviews with BMET supervisor for the corrective actions needed. 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 Incoming inspection of new general medical equipment to include performance verification, electrical safety inspection, and recording equipment inventory information. 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 as necessary. Obtains parts ordering information and provides ordering requests to the Supervisory BMET for approval Documents all work completed on an electronic work order per Biomedical Engineering?s standard operating procedure Accomplishes work in a timely manner within an established framework of policies/guidelines. Regularly reports equipment and job statuses and communicates daily with 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. MUST HAVE EXPERIENCE ON THE FOLLOWING EQUIPMENT TO BE CONSIDERED : Dental Lab Equipment Defibrillators AEDs Vital Sign Monitors http://www.mssserv.com/...

Biomedical Technician (BMET)

BIOMEDICAL ENGINEERING TECHNICIAN (BMET) (General Medical Equipment) STATEMENT OF WORK 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 medical equipment (see specifics below). Finds causes of failures of assigned equipment and reviews with BMET supervisor for the corrective actions needed. 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 Incoming inspection of new general medical equipment to include performance verification, electrical safety inspection, and recording equipment inventory information. 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 as necessary. Obtains parts ordering information and provides ordering requests to the Supervisory BMET for approval Documents all work completed on an electronic work order per Biomedical Engineering?s standard operating procedure Accomplishes work in a timely manner within an established framework of policies/guidelines. Regularly reports equipment and job statuses and communicates daily with 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. MUST HAVE EXPERIENCE ON THE FOLLOWING EQUIPMENT TO BE CONSIDERED : Dental Lab Equipment Defibrillators AEDs Vital Sign Monitors http://www.mssserv.com/...

Biomedical Technician

Biomedical Technician The Rogosin Institute is a non-profit medical care and research organization affiliated with New York Presbyterian Hospital and Weill Cornell Medical College of Cornell University. Rogosin is one of the nation?s premier centers for the diagnosis and management of kidney disease. The Institute also treats patients with diabetes, hypertension, lipid disorders and cancer and conducts research in these areas. We currently have a need for an experienced Biomedical Technician who will be responsible for repairing all dialysis machines, water treatment and ancillary medical equipment, and assist in the maintenance of the physical plant. The position requires certification from the manufacturers of the dialysis equipment (Fresenius 2008T) and the water treatment system (Marcor 23G) in addition to basic electronics knowledge in the utilization of multimeter, leakage tester, and other related electrical equipment. The Biomed Technician will train the personnel in operation of dialysis equipment and water treatment system, and provide twenty-four (24) hour on-call coverage as assigned....

Biomedical Equipment Technician

Immediate Openings GDC Medical Electronics is seeking full time entry level and trained Biomedical Equipment Technicians, proficient in repairing and maintaining a variety of medical equipment such as scales, oxygen concentrators, CPM machines, vital signs monitors etc. Unique opportunity to repair high tech equipment such as pharmacy packaging systems, scrub suit dispensers, UV Disinfectant machines, DNA Testing Laboratory equipment, ultrasound equipment etc with manufacturers training. Experienced Biomedical Technicians: should have medical equipment background. Military or technical school graduate with a degree in electronics and related experience considered. Responsibilities include, but not limited to: * Performing scheduled maintenance * Maintaining equipment and documentation to meet Joint Commission and other regulatory standards * General troubleshooting and problem solving to effect repairs * Excellent customer relationship skills * Running diagnostic programs * Excellent documentation skills * Inspecting, testing, and calibrating equipment Position Requirements: * AS degree: Electronics or Biomedical Engineering. * Proficient in English and must have ability to communicate effectively * Knowledge of electronic principles and ability to read wiring diagrams A CBET certification is a plus....

Senior Biomedical Engineer

Senior Biomedical Engineer Designs, develops and validates hardware and software systems for biomedical signal processing applications such as ECG monitoring and alarm processing, shock able ECG rhythm analysis, pulse detection, CPR monitoring, etc. Plays a supporting role in the specification, design and validation of new and improved signal processing subsystems (including both hardware and software) for incorporation into ZOLL cardiac resuscitation systems. Identifies, develops and/or acquires development tools (e.g. DSP design tools, physiological signal databases, and test systems) required to effectively develop and test biomedical signal processing systems. Works closely with hardware/software Engineering teams to develop and validate complete physiological signal acquisition and processing subsystems and to integrate these subsystems into complete marketable products. Assists Pre-production QA, Technical Service and/or Quality Assurance in the technical investigation and resolution of field complaints related to biomedical signal processing issues Works with internal teams, clinical research, and outside clinicians and biomedical Engineers to specify and evaluate new and improved signal processing systems, physiological sensors, and medical devices. Operates independently with weekly or biweekly supervision from Project Leader or Department Manager. Essential Functions: 50% Specifies, designs, develops, supports and validates new and improved sensor and signal processing hardware and software for ZOLL physiological monitoring and treatment products. Provides the technical focus and direction for the development efforts required for a project. 30% Identifies, acquires and or develops tools required to effectively develop and test biomedical signal processing systems and subsystems. 20% Supports project teams and quality assurance in resolution of field issues....

Senior Biomedical Engneering Technician

Senior Biomedical Engineering Technician ? Job Number 1501308 At Stony Brook Medicine, the Senior Biomedical Engineering Technician ensures that medical equipment is well-maintained, safely functional and properly configured. Duties of a Senior Biomedical Engineering Technician may include the following but are not limited to: ? Inspect, repair and calibrate, and perform preventive maintenance on hospital medical devices. ? Performs acceptance and quality assurance testing of medical devices according to protocols. ? Isolates electronic and electromechanical medical-equipment problems on-site and performs the necessary repair in an expedient manner on an emergency basis. ? Installs and assembles medical electronic or electromechanical devices. ? Posts report to the Sr. Biomedical Engineer of the BME Department. ? Participate in training programs as per Sr. Biomedical Engineer. ? Evaluate new products/services as per BME. ? Other Hospital or BME technical duties which will be defined...

BioMedical Technician

. BioMedical Technician - Level 1 or 2 Buffalo, NY Position Summary: Position responds to service calls to evaluate, diagnose and perform repair and planned maintenance (PM) on biomedical electronic equipment, verifying proper condition and operation. Position Responsibilities: *Respond to service calls to evaluate, diagnose and perform repair and planned maintenance on biomedical electronic equipment; verify proper condition and operation. *Evaluate hospital clinical equipment complaints and implement appropriate repairs, maintain effective customer relations and hospital protocol at all times. *May assist more experienced technicians on complex repairs. May assist and provide support to Biomedical Technician I team members. *Enhance and maintain technical knowledge of current standards, codes and procedures regarding safe and effective use of medical equipment through independent and/or formal instruction. *Perform safety and environmental inspections on equipment. *Document and report repeated or potential device operations problems to immediate supervisor. *Provide instruction to hospital personnel on clinical equipment operation as appropriate. *May perform special/limited device installations and/or follow-up on specific field tests of new or improved device modifications. *Follow appropriate policies, procedures, and hospital protocol, and complete necessary documentation. *Maintain approved parts inventory for assignments. *Document all repair actions and submit reports/summaries according to schedule. *Ensure proper care of spares, tools and other related and assigned equipment. *Share on-call / pager responsibility as required for area. *Perform other related duties as assigned....

Biomedical Eng. Tech Lead BMET III

CFFI has a great opportunity for an experienced leader and strong BMET professional. We will offer competitive pay and benefits, so apply today to join the Cape Fox team! The Lead BMET III possesses all of the qualification for BMET III with ability to lead and manage subordinate BMETs. He/she has comprehensive knowledge of policies, practices, procedures, and types of equipment. The BMET III Lead is knowledgeable in the theory of operation, the underlying physiological principles and the safe clinical application of biomedical equipment. The BMET III applies electrical, electronic, mechanical, chemical, optical and other engineering principles to performance maintenance services, repairs and overhaul of all medical equipment and medical systems. Duties include but are not limited to: Manage subordinate BMETs. Complete assigned preventative maintenance and other scheduled services. Assist in the development of preventative maintenance procedures and Standard Operation Procedures (SOPs). Document the results of all inspections, maintenance and tests in the current maintenance database. Troubleshoot and repair medical equipment, medical equipment systems and devices. Rebuild equipment and report equipment requirements to COR. Maintain equipment inventory in the current maintenance database to include tagging, recording, reporting of equipment additions/deletions, and documenting service events. Communicate with the customers regarding equipment status and proper orientation of equipment. Provide in-service training, presentations and orientation on new equipment. Be aware of and utilize necessary references to gather information needed to acquire necessary repair parts which may include parts for medical equipment no longer supports by the Original Equipment Manufacturer (OEM). Serve as a technical advisor in the purchase of new medical equipment. Salvage critical components and properly dispose of parts that contain toxic, radioactive and environmental hazards and HIPPA/PII devices if a piece of medical equipment cannot be repaired. Maintains safe work environment by participating in all safety related training; rectifies unsafe conditions immediately....

Biomedical Engineer Research

Job Summary Responsible for CV Surgery research projects involving 3d printing, medical devices, and large quantity of data. Responsible for documenting and collecting data from human subjects on research projects. Minimum Job Requirements Bachelor?s degree in Biomedical Engineering required Significant relevant experience in Biomedical Engineering research as evidenced in publications in peer reviewed journals and/or recommendation letters...

Biomedical Technician III, Clinical Engineering - Full Time

COME FIND YOUR PLACE! Arnot Health - Arnot Ogden Medical Center- Elmira, New York Full Time, Day/Occasional Rotation Shift Job Summary: Performs a variety of technical duties providing for preventive maintenance (PM), repair, overhaul, modifications, evaluation and clinical support for a broad spectrum of patient and non patient medical equipment. Provides guidance or technical support to other Biomedical Technicians and Vendors as required or assigned. Reports to the Director of Clinical Engineering. Arnot Health strives to be the employer of choice for health care professionals! Visit us online! www.arnothealth.org...

Biomedical Electronics Tech

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. About Sequoia Hospital Dignity Health Sequoia Hospital is an accredited, not-for-profit community hospital providing innovative and exceptional health care for generations of Bay Area residents. Sequoia"s Heart and Vascular Institute is a nationally known pioneer in advanced cardiac care, affiliated with the Cleveland Clinic Heart and Vascular Institute. Sequoia has received national recognition as one of America"s top 100 hospitals, as well as for superior patient safety and cardiac care from Healthgrades. The hospital has been voted A Family Favorite Best Birth Center and Best Hospital by readers of Bay Area Parent magazine for five consecutive years. In 2014, Sequoia received the American Heart Association"s Get With the Guidelines Silver Award for stroke care. Sequoia Hospital"s new Pavilion opened to patients in October 2014. With the addition of the new Pavilion, Sequoia is one of the most advanced health care facilities in the Bay Area. To learn more, please visit our website: www.SequoiaHospital.org Join our community: http://www.facebook.com/SequoiaHospital http://twitter.com/SequoiaHospital Watch our videos: www.youtube.com/SequoiaHospital Equal Opportunity Dignity Health is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected Veteran status. For more information about your EEO rights as an applicant, please click here ....

Bio-medical Technician job located in San Diego, CA (Electro-Mec

. Adecco Engineering and Technology is currently recruiting for a Bio-medical Technician job located inSan Diego,CA. The ideal candidate must have strong Electro-Mechanical skills as well as Medical Device experience (Big Plus). The responsibilities of this position will be to repair and update medical devices. This will be a traveling position thought-out theUS, traveling to hospitals to repair medical devices. 15month contract. Bio-medical Technician responsibilities: Will travel to various hospitals throughout theUnited Statesrepairing biomedical equipment Will work with local techs to repair parts on medical devices. Will required advanced Electronics and Mechanical skills. Will have to offer excellent customer service working with doctors and nurses onsite Will have to be able to travel on your own with the ability to be on time and work independently Qualifications: The ideal candidate will have strong Electro-Mechanical skills as well as experience working with and repairing Medical Devices (Big Plus) Mechanical, Troubleshooting and Assembly skills required Excellent customer service skills required; ability to work with and communicate effectively with team members and hospital personnel Test operates unit to locate defects, measure performance, determine need for adjustment, and verify specified operation Determines part usage, disassembly/assembly procedures, preventative maintenance requirements, level of testing needed, and required adjustments based on technical service manual and other documentation Requirements This position will require 85-90% travel (includes overnight, multi-state travel) for hospital-based work (Travel will be weeks in a row/ consecutively) Ability to lift 30 pounds and work in a variety of workplace environments. Thorough background, drug, and DMV screens will be administered prior to employment (Must have a clean Drivers record- No DUIs Must be at least 25yrs of age to rent an Automobile. The pay rate is $25/hr plus a good amount of Over Time. All travel expenses are taken care of up front plus daily expenses for food. Reimbursed up to $50/day for meals To be considered for the Bio-medical Technician job located in San Diego, CA, you must use the ?apply now? button to submit your resume. If you have questions about the position please contact James Ramirez at Or call 858-812-9815 Equal Opportunity Employer Minorities/Women/Veteran...

ENGINEERING MANAGER

Our Client is seeking an EngineeringManager for a direct hire position in the Baltimore, MD area. Positiondetails follow. If you are qualified and interested, please forwarda Word copy of your resume to withSubject code: EM-MD . . . ENGINEERING MANAGER JobID : EM-MD PositionType :Direct Hire Location: Baltimore, MD Education: BS in Mechanical orBiomedical Engineering Compensation: $70k up to $100k to start plus benefits . . . JobDescription: Our client isseeking an Engineering Manager to Oversee engineering team and projects fromconcept to production by adapting and applying best practices to developcreative and innovative solutions to product design problems for diverseprojects with a focus on biomedical . . . Responsibilities: Management responsibility for entire Engineering Department Set team and individual responsibilities, objectives, and milestones Conduct formal 6 month reviews of each engineering employee Make or recommend decisions regarding employment (hiring, promotion, or dismissal) Authorize, track, and report employee time off to HR Work with Project Management to manage project loading and assign tasks to engineering team members Report to senior management weekly with department updates, suggestions or concerns Assume role of design lead on projects per you discretion, and assign design lead to other team members on projects to your discretion Perform CAD work as needed to achieve project results using best industry practices Work with your team to develop protocols and build fixtures for component validation, testing, and assembly Communicate effectively with customers and vendors Oversee engineering teams use of tools and assume responsibility for adherence to defined procedures Work with Quality Assurance Manager to define, track, train, and change procedures and practices with a focus on continuous improvement Make recommendations with regards to workflow, software or other tools, and capital purchases Coordinate and instill good engineering processes for design and document control Occasional travel, domestic and international, for site review, first installation, and general meetings...

Program Director, Medical Equipment Management Systems

The Program Director, Medical Equipment Management Systems serves as primary agent for requirements development, monitoring and evaluation of the medical equipment management plan. Exercises oversight and management responsibility for all program requirements, including supervision of assigned staff; development and continued improvement of program standards, procedures, and processes; execution of program directives as determined through collaboration with pavilion Director(s), Biomedical Engineering and the Associate Administrator, Healthcare Systems Eng. department; proposes multi-year program forecast for strategic project planning and budgeting; establishes and maintains integrative relationships with Information Technology, Facility Engineering, and Biomedical Engineering departments for program activity and continuity; primary agent responsible for annual Plan evaluation, program risks assessment, performance improvement initiatives, and annual reassessment of program requirements; provides leadership for the development of any identified corrective action activities resulting from regulatory compliance inspection actions....

Sr Biomedical Equip Specialist

Senior Biomedical Equipment Specialist for service, repair, and support of Linear Accelerators, including inspections, troubleshooting, repair, calibration, and performance verification of computer based Medical Linear Accelerators at all MLHS Radiation Oncology facilities. This position is required to be familiar with all classes of clinical equipment normally utilized in a Radiation Oncology department. The Sr. Biomedical Equipment Specialist serves as an advisor to medical and clinical staff in the specification, acquisition, safe use, and proper operation of specialty equipment and to other radiology specialists on technical matters concerning Radiation Oncology equipment. The position ensures regulatory compliance, assists in inventory management, and contributes to department improvement and development by participating in critical decision making with other associates. Education: 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. Associates degree in a technical/electronics field or equivalent military training required Bachelor degree in electrical engineering or associated discipline preferred. Licensures & Certifications: CRES- (Certified Radiology Equipment Specialist) is preferred. Multi-Vendor Service School Certification preferred. Valid driver?s license required; variable travel requirements depending on primary site that will require use of personal vehicle Experience: Six years experience in a related discipline required with a minimum of two years experience in specialty area required. Multi-vendor Linear Accelerator experience required. Computerized Tomography and Server based network experience preferred. Specific experience on Varian linear accelerators and authorized Varian training are highly desirable. Entity Main Line Services Department Biomedical Engineering Shift Weekend Requirements Salary Grade 214...

Biomedical Engineer II

Bartlett, TN - The Biomedical Engineer is responsible for engineering the design, development and management of new and existing ENT products. The incumbent is to act as a technical consultant as needed to other departments, customers, and sales people. EOE M/F/D/V * Maintain responsibility for the design and development of new products. * Maintain responsibility for development of product specifications. * Prepare product specifications including materials, functional characteristics, processes, quality control procedures, etc. * Collect and maintain applicable technical, clinical, and commercial literature relating to the background and development of specific products or procedures. * Establish appropriate test protocols for product validations. * Initiate and review applicable product testing and clinical evaluations. * Maintain responsibility for planning and scheduling all assigned projects. * Stay current with new developments, materials, or processes which can be used to improve the function or production of products. * Consult with the appropriate product manager and clinicians, when necessary, to facilitate proper design of new or modified products. * Initiate the preparation of product prints, and act as a consultant during their preparation. * Consult with other departments such as purchasing, manufacturing, and sales to obtain services or information pertinent to functional needs. * Manage, direct and support vendors involved in product development and ongoing production. * Evaluate and approve design changes, specifications, and drawing releases. * Investigate critical product/process engineering problems on demand. * Help prepare and act as a consultant to marketing on technical brochures, training programs, and technical presentations to customers or the sales force. * Follow GMP, FDA, ISO, and Gyrus operational procedures. * Perform other related duties as assigned. (ONLY QUALIFIED CANDIDATES WILL BE CONSIDERED) * Bachelor's Degree in Biomedical Engineering, Materials Engineering or equivalent engineering discipline is required. * Minimum of 2 years of product development experience is required. * Proficiency in the design of test fixtures for the qualification, performance and verification/validation tests of new and existing products is required. * Master's Degree preferred. * Experience in medical product development preferred. * Must have strong written and oral communication skills. * Proficiency in the design and development of biomaterials is essentials. * Must have a solid understanding of the design, development, and tolerancy of complex systems. * Experience in the design and development of implantable materials and experience working with materials of natural/biological origin is a plus. * Experience in the design and development of products subject to domestic and international standards (UL 2601, ISO 60601, etc) is essential. * Must be comfortable leading multidisciplinary teams in bringing a project from conception through market release. * Must be self-motivated with a strong sense of urgency. * Must have a sense of ownership and a desire to follow a project from inception to full production. * Proficiency in the use of CAD to create models for use in design, prototyping, and developing medical devices is necessary. * Must have working knowledge of basic Microsoft Applications including Word, Excel and Project. * Must have working knowledge of 3-D CAD (SolidWorks preferred). * Must have working knowledge of CAE programs (mechanical FEA or CFD). * Must have working knowledge of QAD/SAP. The following physical demands and work environments exist: Lift/Carry 25 lbs. Microscope/Fine close work 8 hrs a day. Bend/Stoop/Kneel 2 hrs a day. Stand/Sit/Walk 8 hrs a day. Push/Pull 50+ lbs. Chemicals/Solvents Infectious Disease exposure. Clean Room. Noise above 85 decibels....

Software Engineer

Stryker is currently recruiting for a Software Engineer to work in Fort Lauderdale, FL Based in Fort Lauderdale, FL the Robotics unit at Stryker is an industry pioneer in surgical robotics for Orthopedics. Our products for partial knee replacement and total hip replacement are market leaders. Join a world-class team to change the future of orthopedic surgery. Key Responsibilities: Work as a part of a team using established company procedures for Agile Software Development Maintain existing code and develop new code in Tcl/Tk or C++/Qt for surgical applications Participate in formal verification and validation activities Follow company standards for design control Follow the company?s quality process and comply with quality management system procedures Participate in software planning and estimating activities Identify root causes of issues and determine potential solutions Ensure the integrity and security of company intellectual property and confidential data Comply with ongoing training requirements Attend and support labs...

Software Engineer

Stryker is currently recruiting for a Software Engineer to work in Fort Lauderdale, FL Based in Fort Lauderdale, FL the Robotics unit at Stryker is an industry pioneer in surgical robotics for Orthopedics. Our products for partial knee replacement and total hip replacement are market leaders. Join a world-class team to change the future of orthopedic surgery. Key Responsibilities: Work as a part of a team using established company procedures for Agile Software Development Maintain existing code and develop new code in Tcl/Tk or C++/Qt for surgical applications Participate in formal verification and validation activities Follow company standards for design control Follow the company?s quality process and comply with quality management system procedures Participate in software planning and estimating activities Identify root causes of issues and determine potential solutions Ensure the integrity and security of company intellectual property and confidential data Comply with ongoing training requirements Attend and support labs...

Biomedical Validation Engineer

Our client, located in Mahwah, NJ is currently in search of a Validation Engineer to join their team. The ideal candidate will possess the following experience and knowledge, preferably in a biotechnical/biomechanical environment. Location: Mahwah, NJ Position Type: Contract Validation Engineer Job Description and Requirements: Carry out and lead validation activities for manufacturing processes, which include equipment qualifications, process qualifications, software validations, process capability studies, and process improvements. Support process development and design transfer activities, including, but not limited to, process mapping, operating procedures, inspection plans, MSA/gauge R&R studies, First Article Inspection, and training. Author well-defined Macro/Master Validation Plans for summarizing and laying out detailed validation activities. Develop/write/execute IQ, OQ, PQ validation protocols for simple and complex manufacturing processes and their respective equipment, including utilities, software, and hardware. Draft and complete Final Reports and/or Closure Reports for validation documents. Generate and resolve protocol discrepancies and/or deviations that may arise as part of validation execution. Assist and support validation activities and process development activities wherever needed. Draft operating procedures and applicable manufacturing documents necessary for process performance. Gather and analyze data using Minitab statistical software or equivalent to identify critical parameters, understand process performance, and improve process capability. Participate in project planning, scheduling, and tracking. works, is...

Clinical Engineer - Manager of Radiology Services

General Summary Under limited supervision, organizes, directs and coordinates the work of radiology service, contract management, installation, and decommissioning; helps manage the Radiology and imaging Capital Program and. works with Clinical Engineering and Radiology Departments in planning their future equipment requirements. Principal Responsibilities and Tasks The following statements are intended to describe the general nature and level of work being performed by people assigned to this classification. These are not to be construed as an exhaustive list of all job duties performed by personnel so classified. The Radiology Service Manager?s duties shall include: 1.Establishes and implements equipment monitoring, maintenance, and testing procedures. Provides management and administration of the equipment support services; technical counsel to staff on codes, standards and best practices. Consults with radiology director, staff, clinical and biomedical engineering, ancillary and medical staff regarding operational issues, equipment problems, initiatives and projects as needed. Coordinates and communicates with and among all biomedical, radiology departments and manufacturers of equipment, and third parties with respect to equipment maintenance services; Prepares and delivers any operational reports on a mutually agreed upon schedule; and Analyzes costs of the Customer?s Equipment maintenance services. Consults with senior leadership and medical staff?s clinical service needs to obtain sufficient information to enable determining best combination of technical solutions in equipment/software/practice that will satisfy the requirement. 2.Determines staffing requirements and supervise and mentors the work of all engineering staff to ensure effective and efficient departmental functions. Establishes and monitors work flow; determines work assignments, and assigns staff accordingly; schedules activities; schedules technical activities in accordance with applicable Quality Assurance Plan and without interruption to patient service. Performs individual performance evaluations to ensure the overall satisfactory performance of the department. Provides ongoing staff training and development, through to keep abreast of developments in the field Establishes clear and concise work procedures and expectations, assesses performance, monitors results and provides positive and constructive feedback. Recommends new hires, corrective action counseling, discharges, personnel changes and salary adjustments. Obtains approval from Director of Clinical Engineering 3.Designs and develops quality assurance measures which monitor the consistency and quality of services. 4.Manages to all regulatory agency requirements associated with radiology and imaging equipment to ensure patient and employee safety. 5.Determines in consultation with the key radiology and biomedical staff the appropriate approach to equipment maintenance and services. Establishes service requirements, service standards, and service vehicles. 6.Manages the Clinical Equipment Operating and Capital budget in collaboration with the Director of Clinical Engineering, the VP Facilities, and Finance. Monitors and controls labor, materials, contracted services and other expenditures. Documents, communicates and enforces replacement and new equipment. Maintains documented and customer agreed-to multi-year plans for equipment replacements and coordinates with system financial planning activities. 7 Develops, implements, and assures adherence to Radiology Service practices and general departmental policies and procedures to improve the operational efficiency of the engineering and technical activities of service. Recommends more effective/efficient practices to Director of Clinical Engineering for improvement of the department?s functioning. Communicates policy and procedure changes to staff, as appropriate. 8.In absence of Director being available, the Manager, Radiology Services will function in place of the Director with authority as delegated in advance by the Director....

Instrumentation Technician

Instrumentation Technician, San Jose, CA With minimal supervision, evaluate progressively complex, customer biomedical equipment issues, implement appropriate repairs; as assigned, perform planned maintenance (PM), safety and environmental inspections and maintain effective customer relations. Follow appropriate Client policies, procedures, hospital protocol and complete necessary documentation. Maintain daily communications with customers, to ensure resolution and proper follow-up, leading to customer satisfaction. As instructed, implement Client/ customer facility contract, supporting business goals and objectives. May assist more and less experienced technicians on basic and complex repairs/ resolution respectively. Work as a member of local team to provide efficient service delivery to all accounts within assigned area. When trained, share on-call/ pager responsibility. Document all repair actions and submit reports/summaries according to schedule. Ensure proper care of spares, tools and test equipment and ensure calibration. Maintain approved parts inventory. Manage vendor?s service delivery processes in compliance with Client policies, as instructed. Enhance and maintain technical knowledge of current standards, codes and procedures regarding safe and effective use of medical equipment through formal instruction. Meet Health and Human Services, Environment Health and Safety requirements and/or all other applicable regulatory requirements. Perform other related duties as assigned. Minimum of High School Diploma/GED required. Minimum of one-year military experience or other equivalent formal training in maintaining electronics, electromechanical or medical equipment. Minimum of an Associate?s degree in Electronics or Mechanical Principles. AND a minimum of two years of experience performing troubleshooting and planned maintenance on basic biomedical equipment following current standards, code and procedures to ensure safe and effective operation of those devices. Proficiency in completing electronic documentation using PDA and computer skills. Experience interfacing with both internal team members and external customers as part of a solution based service process. Change agent and process-oriented....

Staff Hemocompatibility Research 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 Staff Hemocompatibility Research Engineer to work with our innovative R&D team in Burlington, MA . The Staff Hemocompatibility Research Engineer requires an extensively experienced research scientist, hematologist, or biomedical engineer ready to drive Thoratec projects from initial concept, through development, and into the mainstream academic and research based community. This technical expert will utilize long experience in the following focused areas of technical skill and reasoning: Analyzing mechanical and biological systems Overseeing the development and completion of a variety of tests Linking these test results to clinical outcomes Driving next generation design requirements Documenting findings to steer the technical direction of the research and development teams. This individual will also be responsible for the evaluation of blood and protein damage, coagulation, and thrombosis Responsibilities: This position is responsible for, but not limited to, the following: Direction of engineering & research tasks such as: Analysis of physical systems (e.g. in terms of stress, heat transfer, residence time, etc.) Design of physical systems including product, fabrication tooling, and test fixtures Verification and validation activities Modern understanding of new technologies and research tools Appropriate application of theory and commercial or custom software tools Understand the root cause of technical problems encountered (e.g. by observation, manipulation, and testing of failed systems, and proposing solutions) Thorough completion of documentation associated with work product Integration of academic and experiential knowledge and application to new solutions Effective, persuasive communication of work product to the entire organization as well as academic and research based institutions Drive seminal research initiatives Create intellectual property Coach and mentor colleagues General support of Quality, Regulatory Affairs, Sales and Marketing The ability to make critical judgments and decisions Lead engineering & research projects as necessary Technical proficiency commensurate with organizational level...

Manufacturing/Production Engineer

Manufacturing/ Production Engineer, Warsaw, IN Responsible for specific phases of design, development, installation, qualification, troubleshooting of production equipment and processes. Identify and resolve manufacturing problems expeditiously with attention to impact on cost, quality schedule and resources. Responsible for instituting and maintaining financial controls for all project forecasting and spending. Design duties include original design of production equipment and upgrades of existing equipment including automation and control. Reviews activities of engineering interns on a recurring basis, reviews progress an devaluates work results. Hands on mechanical-design background to interface with outside contractors and in a machine shop environment. Independently performs project activities with minimal direction. Manage projects and develop project costs and schedules based on customer needs. Set objectives, plan and schedule multiple projects to accomplish defined objectives. BS Degree in Engineering Disciplines or Biomedical Engineering. 8 years related experience...

Design Quality Assurance Engineer

Duties : Provide validation test development, execution, and results tracking for biomedical device projects in ZOLL Research & Development. Will conduct functional testing on all ZOLL deliverables, from standalone code to complete products and systems. Will be an active participant in product and subsystem requirements development, as well as Test Plan reviews. Essential functions include: Implementing, reviewing and creating validation/verification test cases and test plans both for DQA and development teams. Performing all testing as assigned. Identifying, reporting, and following up on test failures and observed defects. Working with product development teams to isolate failure methods to reproduce product problems....

STAFF PRODUCT QUALITY ENGINEER Job

STAFF PRODUCT QUALITY ENGINEER-2578150330 Description Advanced Sterilization Products Division of Ethicon, Inc., a member of Johnson & Johnson's Family of Companies, is currently recruiting for a Staff Quality Engineer located in Irvine, CA. ASP (Advanced Sterilization Products), a member of the Johnson & Johnson Family of Companies, is a leading designer and developer of innovative instrument sterilization, high-level disinfection and cleaning technologies. The company is dedicated to providing infection prevention solutions that create the safest possible environments for patients, healthcare providers, and communities. ASP is based in Irvine, California with offices around the world. For more information, please visit http://www.aspjj.com/ or follow us at www.Twitter.com/aspjj. Position Description- the duties and responsibilities of this role include but are not limited to: The Staff Quality Engineer will be responsible for providing Quality System Regulatory interpretation, consulting, training, and assessment to ensure product teams are aligned with current regulatory requirements, standards, and current industry trends. Other responsibilities include providing constructive technical challenge to the design and development of a product or process to drive better product or process performance and project outcomes, as well as developing the Reliability Requirement for products and provide leadership in driving product reliability requirements and the full implementation the identified requirements. The Staff Quality Engineer will also ensure that documented evidence exists to demonstrate a high degree of assurance that specific design and processes will consistently and continually produce a product that meets specifications and critical to quality attributes. The Staff Quality Engineer will lead project teams by utilizing risk management process and tools; and effectively drives reasonable and appropriate risk controls; lead complex investigations, coordinate technical teams to ensure sound experimental design, effective data analysis, risk analysis, design verification and validation and subsequent closure to technical investigations. Additionally, the Staff Quality Engineer will provide Advanced Statistical Analysis support and utilize various Statistical Analysis techniques and tools. Conduct or support failure and complaint investigations; initiate and supports continuous process improvements within area of responsibility and conduct supplier quality system and product audits as needed; and support, perform, or oversee Internal and External Audits and CAPAs; be accountable for preparing and tracking Audit Finding Reports (AFRs) in response to observations from Internal and External Inspections / Audits to ensure compliance with Quality Management System elements. The Staff Quality Engineer will also provide backroom support for 3rd Party Inspections and Audits (e.g. Registrar, Notified Body, FDA, or customer audits), and serves as the technical expert for the organization (worldwide) in the application of advanced theories, concepts, principles, and processes for an assigned area of responsibility (i.e., subject matter, function, type of facility, or equipment, or product). Other duties and responsibilities as assigned. Qualifications Qualifications- the required and preferred skills and abilities for this role include: This role requires a minimum of a B.S. in Mechanical or Electrical or Biomedical Engineering or equivalent with 10 or more years of related experience; or a Master's degree in Mechanical or Electrical or Biomedical Engineering discipline plus 7 or more years of related experience and/or training; or Ph.D. in an Mechanical or Electrical or Biomedical Engineering discipline and 5 or more years of related experience. A minimum of 7 years Quality Systems or Quality Assurance work experience and minimum of 5 years Quality Engineering experience in an FDA-regulated industry (medical device, pharmaceutical, etc.) and working knowledge of 21 CFR Part 820, ISO 13485 and ISO 9001 are required. The ability to provide an expert knowledge of both regulatory requirements and other compliance areas to minimize risk across franchise is required. A strong understanding of appropriate Risk Management regulations and guidance standards, such as, ISO 14971 and FDA Guidance and a thorough understanding in the application of risk management tools, such as, Risk Analysis, FMEA and FTA are required. Strong Quality Engineering skills with working knowledge of product design verification, as well as product and process validation activities are required. Excellent written and verbal communication skill are required. The capabilities of working independently and in a team setting and having the ability to work and communicate in a cross-cultural environment are also required. This role requires the experience to lead a high performance team and drive performance results and work with core teams and development partners to ensure robust design quality practices are embedded and applied. The ability to lead continuous improvement of the new product development processes and procedures, and the ability to integrate reliability techniques as a part of product development or design changes. A working knowledge of Statistical Analysis Software tools (such as, MiniTab, SPC Software, etc.) is required. A strong working knowledge in the use of investigational tools (Cause and Effect Diagrams, Process Optimization, Design of Experiments, Trend Analysis, Capability Analysis, Control Charts, Pareto Charting, etc.) is also required. Additionally, a leadership ability in using problem solving techniques, including root cause analysis and cause and effect analysis, is required. Demonstrated leadership abilities in developing high-quality product reliability requirements for products in partnership with various departments, such as, R&D, product management, Service etc. and monitoring the implementation and execution of these reliability goals are required. This role serves as the technical subject matter and expert and communicates to auditors and investigators. The ability to effectively utilize knowledge of Qualitative Reliability Techniques (such as dFMEA, pFMEA, DFx); Environmental Qualitative Reliability Tests (HALT and HASS) and Reliability Prediction and Ongoing Reliability Test (ORT) are preferred. Preferred experiences also include: a Project Management Certification (example: PMI Certification, Graduate Certificate in Program Management, etc.) or Flawless Project Execution Certificate. This position may require approximately 10-15% national and international travel and will be based in Irvine California. 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-California-Irvine Organization: Advanced Sterilization Products (ASP) Job Function: Quality (Eng) 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, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law. EEO is the Law EEO is the Law GINA Supplement...

Software Engineer

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, genetic information or any other characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please call 844 895-8598 or email accommodation@aerotek .com for other accommodation options. However, if you have questions about this position, please contact the Recruiter located at the bottom of the job posting. The Recruiter is the sole point of contact for questions about this position. Software Engineer Medical imaging system and we are in need of a software engineer to work on the PC based Application GUI. The candidate should have both knowledge and experience working with software design and programming, ideally in imaging systems that include image data acquisition and to display the live image and processing results. The ideal candidate should have experience working as a Software Engineer for a sensor or instrumentation design teams, have exposures to sensor signal acquisitions, manage the data on PCs and calling processing routines, and display and archive the processed data on a GUI. We are NOT seeking an embedded software engineer. The candidate will work in an Application Software programming environment, GUI on a Windows based platform, for example. Working Environment: We use a state-of-the-art video sensor to acquire images at high speed, the Application GUI will manage the video sensor driver level communications, display the live video feed on screen, and store the high speed input data accordingly. We have an Algorithm module in the shape of DLLs, the GUI will call the DLLs to process the data once the image acquisition is done. The processed results will be displayed on screen and archived per standard. We are making a medical imaging system, before every scan of patients, the GUI will provide operators with interfaces to input patient information, this will be stored along with image data and processed results. The software engineer will be working on programming for this application GUI. Responsibilities include: Working as a software engineer to develop PC based software tools and integrate driver level components, such as integrating imaging device supplier SDKs for image signal acquisition. Developing and maintaining company's medical imaging system user interface software, using Java, C++ (QT, MFC), C, C# and other development programs in a PC environment, ideally windows. Working on all aspects of our medical imaging system including imaging sensor operations, user interface software system design, animal/clinical test setup and data collection, and management of image signal processing cores to assist data processing and results presentation. Desired Skills: The candidate will have Bachelor's degree, or preferably an advanced degree, in Computer Science, Computer Engineering, Electrical Engineering, Biomedical Engineering, or related field. Programming capabilities are required; candidate should be proficient in any one of the modern programming languages (C#/C/C++/Java preferred). Open CV and other image processing toolbox experiences are plus but not required, GPU experiences are plus but not required, exposure to Matlab is a plus and knowledge/experience developing/using signal processing algorithms is a big plus The ideal candidate should have working experience in complex electrical system development, ideally in biomedical and/or medical devices. 3+ year direct PROGRAMMING experience desired. The ideal candidate should be proficient in all aspects of software design, including imaging sensor control and configurations, data acquisition on PC platforms, and syndicated user interface software development. The candidate should also be highly detail-oriented, have excellent analytic and troubleshooting skills, is a highly motivated team player adept at cross-functional interaction, and MUST have excellent verbal and written communication skills. 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 ....

Digital Signal Processing Engineer

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, genetic information or any other characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please call 844 895-8598 or email accommodation@aerotek .com for other accommodation options. However, if you have questions about this position, please contact the Recruiter located at the bottom of the job posting. The Recruiter is the sole point of contact for questions about this position. Aerotek is in search of a Digital Signal Processing Engineer for a client in the Gainesville, FL area. Our client is a research engineering firm who specializes in the medical device industry. They are in search of a research engineering position specializing in digital signal processing. The job involves filtering and analyzing data from a variety of biomedical sources and then classifying or identifying the data based on a gold standard. Qualifications- Ph.D. with 1-2 years of experience (preferred), MS with 3-7 years of experience, or 10+ years with DSP focus Matlab Experience working with C programming language Embedded systems with microprocessors Preferred Qualifications- DSP with focus on Biomedical or medical device type products (EKG, Fetal monitors, Ultrasound machines, etc.) Experience with Start-up company Experience working independently on projects This position is a long term, direct placement position and pay is dependent on experience. Relocation assistance is available if needed. If interested in the position, please email your resume to Sean Wright at 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 ....

Engineer-Mechanical Design Medical Devices

We are seeking highly motivated technical design professionals with a start-up mentality to join our new Drug Delivery and Device Innovation Center in Cambridge, Massachusetts, to explore, develop and prototype new and emerging technologies. This new center is a multidisciplinary studio helping realize the future. If you wish to apply your deep engineering knowledge to push technical frontiers, and use Design Thinking methods to create breakthrough solutions for patients, you should consider joining our diverse team. We seek to explore and apply new technical solutions across delivery systems, with focus in the following areas: Drug container design with consideration of materials, coatings and unique packaging concepts Injection/infusion fluidic control systems Mechanical and electromechanical systems Electronic communication and firmware Software and connected delivery solutions The ideal individual will be at the forefront of their respective field, and be able to take initiative and work independently. As important, they will be an effective collaborator with many different constituents: Local team members Injection/infusion fluidic control systems Technical colleagues in the Indianapolis Lilly Technical Center Other related design disciplines Partner consultants, including world class design firms Positon Responsibilities: Evaluate, develop and design mechanical systems for drug delivery. Understand, inform and support the delivery and device platform strategy; how the strategy is informed by internal (molecule/ pipeline needs), external needs (patient, market and technology trends) and how it ultimately drives improved patient outcomes. Identify and monitor disruptive delivery and device technologies as well as trends in patient centered disease management (i.e. diabetes connected product systems and patient support systems) Work with external partners to design and prototype early concepts to support the delivery strategy. Connect with the broader Lilly organization including Delivery and Device R&D, Medical, Marketing, Formulation and Discovery to inform areas of development. Understand IP, freedom to operate and competitive landscape in targeted areas of research....

Programmer Analyst

Ref ID: 00410-9752378 Classification: Programmer/Analyst Compensation: $75,000.00 to $85,000.00 per year Programmer Analyst -Does Health Awareness and Biomedical interest you? -Are you a SQL, VB, Microsoft Access guru -Are you have that data / analytical mindset -This is a DIRECT HIRE! We are seeking a bright, collaborative, self-reliant Programming Analyst. This a direct hire opportunity, conveniently located in downtown San Francisco. Join a leading institution in health promotion through advanced biomedical research. Get involved with improving the quality of health and human life. This opportunity is with as wellestablished and reputable financial firm. You will work with a team of impressive team on developers with the best dynamics an engineer could as for. FOR IMMEDIATE CONSIDERATION PLEASE E-MAIL: or call 415-434-4940...

Mechanical Engineer, Specialist

Company Description: Hill-Rom is a $1.7B leading worldwide manufacturer and provider of medical technologies and related services for the health care industry, including patient support systems, safe mobility and handling solutions, non-invasive therapeutic products for a variety of acute and chronic medical conditions, medical equipment rentals, and information technology solutions. Hill-Rom's comprehensive product and service offerings are used by health care providers across the health care continuum in hospitals, extended care facilities and home care settings to enhance the safety and quality of patient care. JOB SUMMARY: As part of an R&D project team, the Sustaining Specialist Engineer- Surfaces owns the design of a complete module or sub-assembly, from conception to design and verification. He/She works at a senior level and ensures that the project progresses in the defined manner. With his/her expert knowledge, the specialist engineer also provides guidance to other engineers on their technical issues, engages in design reviews and helps resolves the most complex problems. RESPONSIBILITIES: ? Acts as an expert resource and mentor to others ? Applies technical competencies to problems with significant complexity ? Makes difficult design trade-offs and decisions about features, schedule, quality and cost ? Contributes as a technical reviewer in areas of expertise ? Proactively determines measures and standards of success for project, product, and process quality within project teams ? Seeks the optimal technology solutions to problems from internal and external options, and applies appropriate methodology to identify issues/concerns ? Challenges established work processes and proactively finds creative solutions ? Communicates accurately, succinctly, and with purpose up, down and across the organization through written and verbal communication ? Able to perform Root Cause Analysis ? Interface with production personnel and provide design engineering support ? Identify test methods for materials and ability to create test methods...

Field Service Engineer III - Bay Area

The Field Service Engineer III (FSE) is responsible for the overall service and repair of Olympus instrumentation within an assigned geographical area or other areas as required developing skills and/or providing timely customer support utilizing a high level of product based service proficiency of Olympus or directly related equipment and instrumentation dealing with advanced imaging and optics systems. JOB RESPONSIBILITIES: 1. Provide on site system installation, maintenance and repair within an assigned geographical area or as required. 2. Independently conduct repairs, upgrades, preventative maintenance, and system installations and supports in-house operations as required. 3. Ensure timely, professional, and effective response to customer service needs to maintain a high level of customer satisfaction. 4. 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 5. 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. 6. Responsible conducting all travel arrangements as per corporate financial policy 7. Assist other Field Service Engineers and SEG Sales Representatives with product installations, trade shows, demonstrations and other events as required. 8. Proactively works within the region to support key accounts and other customers as required. 9. Responsible for all service parts requested by or assigned to the FSE. Manage inventory in accordance with established policy and procedures. 10. Perform other related duties as assigned. Requirements SKILLS: Capable of making color delineation between all visible wavelengths of light. Must be capable of using hand tools, power meters and other instrumentation for detailed work Must be able to travel by air, rail and automobile to conduct service work in the field Must be willing to travel and work on a non?scheduled basis, including occasional weekends. Must have demonstrated good communication skills, organization, and reliability. Must be able to obtain a passport and travel internationally without restrictions. Must have a valid driver?s license and clean driving record. EDUCATION and EXPERIENCE: Bachelors Degree in Biomedical, Mechanical or Electrical Engineering preferred. Associate degree in Engineering Technology, Electronics, Biomedical Equipment Technology or related field. In lieu of above, a minimum of 4 yrs of military electronics repair may be acceptable. Minimum of 3 years of experience providing field service or related field is required. Olympus Scientific Solutions Americas provides competitive benefits for it's employees: Choice of 3 Medical Plans Choice of 2 Dental Plans Vision Plan 3 Weeks of Vacation to Start 1 Personal Day 5 Sick Days 10 Paid Company Holidays Generous Tuition Reimbursement 401k Match Up to 7% Company Paid Short and Long Term Disability Insurance Olympus IMS is an equal opportunity firm. We recruit, employ, train, compensate and promote without regard to race, religion, creed, color, national origin, age, gender, sexual orientation, marital status, ancestry, genetics, disability or veteran status. Notes...

Senior Quality Engineer

Exciting career opportunity for an experienced Senior Quality Engineer to join a well-established and reputable medical manufacturing company in the Stockton, CA area. The Senior Quality Engineer will work with manufacturing and production to ensure that medical devices produced are of the highest quality. The Senior Quality Engineer will also oversee and train other Quality Engineers within the department....

Application Engineer

Precipart is a global company engaged in the engineering, design and manufacture of high precision custom solutions. We provide mechanical components, assemblies, gears and motion control solutions to the most recognized names in the medical, aerospace and industrial markets. With offices in the United States, Switzerland, United Kingdom and India, we have over 230 employees dedicated to enhancing lives through innovative solutions. Precipart is looking for an engineer to join us in developing solutions for critical medical and industrial applications at our campus in Farmingdale, New York. The successful candidate will be supporting the continued growth of our precision mechanical components product line. This is a unique opportunity to work directly with the senior team to define customer requirements and collaborate on the design and engineering of cutting edge technology such as micro machining, 3D printing and advanced materials. Responsibilities Act as project manager, technical advisor and product advocate, actively driving the technology stage of an application Establish and maintain strong relationships with customers and manufacturing partners Provide design and specification development support throughout all phases of the sales cycle Maintain accurate records of target accounts, opportunities, quotes, projects, contacts and correspondence in company databases...

Medical Devices Design Engineer

SHL GROUP We have an immediate opening for a Design Engineer of Medical Devices ; at our Deerfield Beach, Florida headquarters. Our company provides final assembly, labeling and packaging services of drug delivery devices to the pharmaceutical and biotechnology industries and soon clinical fill finish capabilities. Scientist 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 Design Engineer to work in a highly motivated group within our leading production facility. This position will be responsible for performing the necessary engineering development tasks, including investigation, invention, prototype, design (including detail drawings, structural analysis, tolerance analysis, etc.), testing, and validation bringing new and or existing technology to bear on product and design by performing the following duties: In cases of new product implementation, works with CAD designers and technicians to prepare all specs, drawings, documents, material components that are needed to implement the program into manufacturing. Generates and or works with Design Verification department and or manufacturing sites to prepare design verification, validation and test protocols & reports necessary for the execution and successful completion of the project developmental tasks. Direct participation on design reviews, FMEAs. Interact with other departments and functional areas to expedite projects, Provide technical support to customers as required under the direct supervision of Senior Engineer, coordinates the product production and supply for in-house and or customer clinical trials. Continues the technology transfer activity after initial production startup for a relevant period of time. Desired Skills: BS in Engineering (preferably Mechanical or Biomedical) or related degree. Advanced degree in an Engineering discipline is desirable Minimum of 4 years of experience in Engineering experience in the design of medical devices, preferably in mechanically driven mechanisms. Must be able to communicate appropriately and accurately both orally and in writing the progress of assignments and product development efforts. Independent thinker and problem solver with experience in process development is desirable. 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 ....

Clinical Project Manager

This position is open as of 5/21/2015. Technical Project Manager - In Vitro Diagnostics, FDA regulation If you are a Clinical Project Manager with a PASSION to make a difference, please read on! Top Reasons to Work with Us Rewarding Company!! Growth opportunities!! Exciting New Projects!! What You Will Be Doing Manage a program that allows testing close to a patient, and brings this important diagnostic out of the central laboratory. Our project has a true dual-market application in the U.S. and developing countries, and it already has the support of a major pharmaceutical company. The ideal candidate will bring this project for across the finish line while budgeting to timelines and leading the team. -Create and manage detailed timelines, and cope with change in timelines. -Manage and update project budget to align with timeline and deliverables. -Manage and communicate deliverables to internal and external stakeholders. -Anticipate obstacles, delays and change, and then, together with the DFA team, solve these issues. -Manage relationships with sub-contractors. -Provide input and updates to project plans, resource tracking, issues, and risks during the project. -Prepare reports as necessary, compile agendas, lead a meetings -Comfortable managing the science and translating it into a product, but the candidate does not necessarily need to contribute to the science. -Sufficient grasp of detail to edit protocols to run the analytical and clinical studies. -Experienced with preparation and filing of regulatory submissions, and an ability to steer the technical team through the regulatory process. -Lead the selection process of a high volume contract manufacturer. -Preparation/Review regulatory submissions (i.e., 510(k)s, PMAs, IDEs, etc.). -Management of Clinical Data. -Self?sufficient; an ability to operate effectively without close supervision, but with strong partnership skills and ability to clearly define areas of ownership with various science teams. -Collaborate with key stakeholders, balancing competing interests and needs across the organization to arrive at a clear vision, communicating effectively, and aligning various partners along the way. -Manage conflict in a project and steer the conflict to an acceptable conclusion. What You Need for this Position -Prior experience bringing an In Vitro Diagnostic Device (?IVD?) through the FDA regulatory approval process. -5+ year technical project management or technical leadership in IVD, including P&L responsibility. -Brought at least one IVD product through a 510k or de novo FDA approval process -BA or BS, MBA or M.S. preferred. in biomedical engineering, biology or related studies (PhD preferred) -Familiar with taking a product, ideally a diagnostic product, through the manufacturing and commercialization process and have significant experience managing P&L. -Solid manufacturing, technical and regulatory decisions -Regulatory filings. -Solid Clinical Data Management. -A passion for working on projects directly focused on improving the lives of those living in resource-limited settings. So, if you are a Clinical Project Manager with a passion to make a difference, please apply today! Required Skills In Vitro Diagnostics, FDA regulations, Clinical Data Management If you are a good fit for the Clinical Project Manager - In Vitro Diagnostics, FDA regulation position, and have a background that includes: In Vitro Diagnostics, FDA regulations, Clinical Data Management and you are interested in working the following job types: Information Technology, Engineering, Professional Services Within the following industries: Healthcare - Health Services, 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....

Vehicle & Surface Integration Engineer

Company Overview: At General Motors , we?re building on our momentum and we?re changing the way we do things. We?re recruiting more talent from the nation?s top universities and Fortune 100 companies. We translate breakthrough technologies into vehicles and experiences that people love. We are seeking experienced, motivated engineers to support the next generation of industry-leading vehicles through the design studio process. We?re committed to enhancing the product ? with new features, new materials, and new technologies. To do this, we need forward-looking, innovative engineers who can help shape the future of automotive vehicle and surface integration. In short, we?re currently seeking the next generation of game-changers to usher in a new era of automotive innovation. Are you ready to rise to the challenge? About the Vehicle and Surface Integration Role The Vehicle and Surface Integration group is seeking individuals in the following areas: Integration Engineer (Vehicle Packaging) Studio Engineer These product engineering positions involve responsibility for all activities - including development of criteria, creation of typical sections, construction of seating bucks, occupant and vehicle packaging, and creative surface initiation - during the development of vehicles from the earliest ideation through the first prototype build. These roles require an experienced engineer to lead and drive a cross functional product development team. In addition, they require collaboration with peers in the creative design, engineering, manufacturing, and quality functions. The ideal candidate is one who desires to build their technical depth as an engineer within automotive integration. This candidate possesses exemplary communication, project management skills, and is a passionate, hard-working person who enjoys taking on challenges and following through with robust solutions. At General Motors, we are interested in providing you the opportunity to develop your career. The skills built with these roles will allow you to grow a strong interpersonal network. This is a foundational position which, done successfully, will open up numerous growth opportunities within the company. Integration Engineering Responsibilities include: Generating and executing technical solutions that improve the Customer?s overall visibility, accommodation, access, storage and interface with the vehicle for implementation into new vehicle programs. Working cross-functionally to implement cost reduction ideas, product improvement suggestions, and support prototype property development. Supporting Virtual Math Reviews and Assessments for a specific region of the vehicle. Participating in Customer Clinics & developing Loss Functions that quantify the Customers Satisfaction with specific vehicle features or attributes. Studio Engineering Responsibilities Include: Enabling Studio Designs with balanced engineering solutions. Creating Engineering Criteria to support the Studio Designs. Supporting Modeling activities in the Studio (create board drawings, model set-ups, model armatures). Interfacing with Design Center, Engineering, and the Surfacing Groups to ensure criteria and aesthetic compliance....

Catheter Engineer

Position Summary: Our client has an opening for a Catheter Engineer within their R&D team who will contribute to projectsrelated to the Design & Development of new and next generation catheter based medical devices . The position is in a small, cross functional team ofcapable and experienced engineers who are developing the single use componentsof a novel therapeutic system. The R&D Catheter Engineer will contributeto product design & development by identifying design objectives and issues;researching and developing catheter engineering techniques and approaches;verifying and validating designs; and maintaining documentation on existing andnext generation medical device products. The R&D Catheter Engineer willwork with Clinical and Regulatory Affairs, Operations, Quality andMarketing/Sales; meeting performance, quality, and cost goals; whileoptimizing time to market for company products. The initial focus of thisrole will be on the development of verification requirements, test methods,fixtures and verification testing. PrimaryResponsibilities: Through hands-on engineering, contribute to product development programs with a results-oriented attitude: Design of new catheters and/or catheter components Hands-on prototyping of proposed designs Development and documentation of manufacturing processes to support new designs Development of manufacturing and test fixtures to enable production and verification of catheters Development of test methods and protocols to verify performance of new and existing catheters Perform and document testing on new and existing catheters Promote compliance with Design Control regulations and requirements, including specification development, risk analysis, tolerance and manufacturability analysis, and verification and validation protocols and reports for all contributions made to company projects. Work with key clinicians and industry thought leaders to ensure understanding of the clinical needs and capture optimal product design concepts from the onset and on a continuous basis. Actively identify, and develop appropriate relationships with, vendors required to produce components and assemblies for company products. Work within company ECO process to coordinate design changes and documentation....

Mechanical Project Engineer

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. Validation Engineer, Cleaning -(IRC10533)

Qualified candidates must have experience or consider oneself a subject matter expert in Cleaning Validation. Responsibilities associated with this position include maintaining qualified state of cleaning processes and procedures as well as design and implementation of new cleaning processes. The candidate must be well organized and technically sound in understanding of cleaning validation principles including development of acceptance criteria, within a pharmaceutical or medical device manufacturing environment. Strong technical writing including protocol generation, deviation investigation and generation as well as report writing is required. The candidate must be a team player, who thrives in a team environment, but also has the ability to work on their own. TOOLS AND EQUIPMENT USED ? Knowledge of MS Office Suite To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. ? Generation and execution of cleaning validation protocols including the generation, routing and approval of summary documentation. ? Must be able to read and understand engineering P&ID?s and turnover documentation. ? Work with project teams to develop new cleaning processes as well as perform cleaning development studies and sprayball coverage studies. ? Generate and maintain cleaning validation master plans. ? Scheduling coordination, material allocation and management of contract employees when required in order to successfully complete validation assignments. ? Understanding of proper sampling technique for swab and rinse samples. ? Ability to determine and document cleaning validation acceptance limits for process soils. ? Develop cleaning validation sampling plans and collect swab and rinse samples within manufacturing environment. ? Ability to investigate and resolve deviations or non-conformances. ? Ensure that all projects are in compliance with cGMP, cGLP, QSR (including Design Controls), ISO or other applicable requirements. ? Support and address comments and suggestions associated with validation and engineering documentation. ? Change control, non-conformance and CAPA support. ? Participate in FDA inspections, ISO certifications, surveillance audits and customer audits. ? Knowledge of cleaning validation test method development a plus....

Quality Engineer

Our client is a leader in advancing public health worldwide with a commitment to the fight against infectious diseases. Located in Hazelwood, MO they are looking for a Quality Engineer to join their team! PRIMARY PURPOSE AND OVERALL OBJECTIVE OF THE JOB: Responsible for the implementation and maintenance of effective Quality Systems in accordance with FDA Quality Systems Regulation, ISO 9001, ISO 13485 and other applicable country specific regulations. To participate on quality improvement teams for quality assurance, compliance, and continuous quality improvement. Ensures products (including services) are developed, manufactured, tested and delivered according to established procedures that will assure that they meet all quality requirements. CONTEXT OF THE JOB AND MAJOR CHALLENGES: 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.) on the facility Quality Management System and ensures compliance to these regulations and standards. The incumbent will develop quality programs to facilitate continual improvement actions. DIMENSIONS OF THE JOB The incumbent will routinely interact at all organizational levels with any group or function necessary to ensure that the processes for design, manufacturing, customer service and all supporting processes are in compliance with the defined Quality Management System. The incumbent will be responsible for assuring product quality and reliability during all phases of product life cycle particularly in areas of design transfer, manufacturing, and product servicing and support. MAIN ACCOUNTABILITIES Assist in the documentation of quality systems and programs in the areas of management responsibility, auditing, quality trends, quality costs, training, validation, design controls, purchasing controls, corrective and preventive actions, process control, customer complaints, calibration, documentation control, etc. to ensure compliance with FDA, and regulatory requirements. Monitor manufacturing of assigned products, assuring compliance with DMR while providing deviation/waiver guidance and assuring complete and correct Device History Records are maintained Review the adequacy and correctness of changes to Bill of Materials (BOM?s), Assembly Procedures, Drawings, Component Specification, etc. Ensure that the disposition non-conforming materials meet all necessary regulatory requirements and assure adequacy of corrective actions to prevent reoccurrence. Support the Supplier/Internal Audit Program. Participate in internal audits per schedule, and review the results of all audits to ensure resolution of any noted deviations. Participates in plant CAPA activities, including analysis of data and trends in complaints, supplier quality, nonconforming material, training effectiveness, and root causes analysis. Coordinates implementation of corrective actions and preventive measures....

Research & Development Engineers

We are seeking an Engineer 1 and a Test Engineer for our R&D engineering resources to support Critical Care Remediation projects at a large, global Medical Device company located in Irvine, CA. Job Description: R&D Engineer (Consultant), Vascular Remediation Edwards Hemodynamic Monitoring Systems (HDMS) products lead the market in their category world-wide and are growing very rapidly in emerging markets. The HDMS business is looking for a highly motivated hands-on sustaining product development engineer. Description Reporting to the project team leader, candidate will provide R&D engineering support for retrospective product development activities to assure that existing legacy products fulfill user/market needs in accordance with medical guidance and global regulatory agency standards. Execution of activities will be performed in accordance with established policies, processes, and objectives working in cross functional product development teams under the supervision of a more senior engineering mentor. Must have the ability to think strategically and execute tactically to ensure project delivery; make sound business & technical decisions, follow up and complete engineering items; and motivate others to achieve targeted results. Responsibilities: Responsible for the revision and assurance of compliance on Engineering specifications and requirements documents, drawings, quality/regulatory system documentation, validation protocols, closure reports, technical reports, and investigation of core disposable products. Develop and review feasibility studies, technical reports, product verification and validation test protocols and closure reports. May also be responsible for developing design specifications, design documentation, and test strategy. Contribute to FMEA reviews and maintenance. Work closely with cross functional project team members to deliver project's objectives and achieve milestones. This opportunity is technically challenging and will require working knowledge of medical devices and engineering principals, preferably in the area of disposable medical devices with high production volumes. Responsibilities include development and testing of products in accordance with specifications, clinical/customer input, and regulatory & safety standards With minimal supervision, work to conceptualize, design and develop design improvements and review design for manufacturability (DFM). Conduct tests utilizing existing test protocols, or develop new ones as needed and generate related written reports. Develop and qualify test fixturing, test methods and procedures to be used in device qualification testing to support operations and implementation of proposed device modifications. Employ use of statistical analysis techniques and statistical experimental design, as appropriate. Solve technical problems and identify/implement practical solutions based on design requirements and project timelines. Ideal candidate is able to perform as individual contributor (engineering tasks) as the task owner and assist technologists with the execution of their responsibilities....

Mechanical Test Technician

Start Date : 5/19/2015 End Date : 10/1/2015 CONTRACT ROLE Details:- This is a Mechanical role, NOT Software or Electrical. Position Responsibilities ? Prepare, set up and utilize test instrumentation and complex test set-ups. ? Assuring conformance to product specifications, test plans and technical manuals, interpreting test results, troubleshooting test setups, analyzing product anomalies and writing clear, accurate data reports. ? Conduct tests and develop test setups from detailed and non-detailed instructions to verify the functionality of hardware and software systems. ?Reading and interpreting test plans, product specifications and manuals ?Engineering support which includes TMV/TMQ/IQ as well as calibration and metrology services support. ?Working effectively and efficiently in a team environment. ? Proficient in adhering to industry, company, and department policies. ? Areas of testing responsibilities will include; Mechanical testing, consisting of environmental, shock, vibration and drop tests plus barometric pressure evaluations. Electrical testing, consisting of voltage, current, resistance, and capacitance type measurements. Electromagnetic Compatibility (EMC) or Medical Environment tests may need to be run as part of the evaluation test cycles. Basic Qualifications ?2 year Technical Degree (Electronics or Biomedical) or equivalent, 4-7 years? experience. ?Familiar with quality assurance principles for data collection, measurement, statistics and testing. ?Ability to balance several tasks at any one time and communicate progress and concerns in a timely manner. ?Desire and ability to work effectively and efficiently in a team environment. ?Ability to use Microsoft Word and Excel or equivalents to generate data and reports. ?Strong written and communication skills in the English language. ?Need for candidate to have flexible work hours being that some overtime and weekend work may be required....

Technical Leader

Company The seasoned professional will be employed by Turbocoating Corp., one of the main companies of Unitedcoatings Group. Unitedcoatings Group is a world leader in the Thermal Spray industry and is active, through its different operating business units, in both European and American continents, with 3 main Divisions: Industrial Gas Turbine & Aviation, Biomedical, and Equipment. Turbocoating Corp. is settled in Hickory (North Carolina) and is a leader in the ready-to-engine airfoil applications market, namely thermal spray coating/post coating applications for Gas Turbine components. The company currently employs about 80 people, reports sales revenue nearing $20 million, and has a very fast growth path that will lead to more than double the organization and the business in a short period of time. Objective The Technical Leader is responsible for ensuring the proper production, as far as technical aspects, quality, time and accuracy, through the implementation of continuous improvement. Essential Functions The responsibilities of the Technical Leader include, but are not limited to the following: Act as lead technical reference for customer and internal organization in the case of materials, coatings, and assembly application. Read, analyze, and discuss customer required specifications managing all qualification kick-off meetings and put decisions into actions. Works to complete projects on time and within budget. Conducts engineering design evaluations to ensure Design for Manufacturability (DFM) and propose VA/VE proposals. Project leadership of coating/post-coating processes based on Customer requirements. Verify and interpret results in cooperation with the Metallographic Laboratory and the Process Leader. Prepare required customer documentation to qualify new products/processes from kick-off to full release. Continuously improve product / processes and utilize proper change management practices. Develop production costs quotation and related feasibility study. Project leadership to continually decrease manufacturing costs. Determine and approve the process standards of a new component, meet NPI qualification stage gates and milestones, and provide customer products corresponding to the required quality specifications. Develop, check, and improve component standards in order to promote actions for cost savings and process standard improvement. Participate in Root Cause Corrective Action activities to permanently eliminate defects. Utilize 8D and DMAIC approach to problem solving and non-conformances. Adhere to the Company's Quality and Safety Management System and in accordance with its procedures and requirements. Utilize Lean and Six Sigma methods to improve Key Performance Indicators for Safety, Quality, Delivery, and Cost. Participate in Kaizen events, promote positive employee environment, and community involvement. Supervisory Responsibility No Work Environment This job operates in both an office environment and a manufacturing environment. The role routinely uses standard office equipment, such as computers, phones, photocopiers, filing cabinets and fax machines. The individual will be required to adhere to safety policies and procedures on the manufacturing floor. Physical Demands While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to stand, walk, use hands to finger, handle or feel and reach with hands and arms. The employee is occasionally required to sit, climb or balance and stoop, kneel, crouch or crawl. The employee must frequently lift and/or move up to 10lbs and occasionally lift and/or move up to 25lbs. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus. Position Type/Expected Hours of Work This is a full-time position Monday thru Friday 8am to 5pm, additional hours as required. Travel One month of training in Italy is required for this position, after that travel will occur as needed to support the rapid growth of the company....

Clinical Engineering Manager I

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....

Automation Engineer Co-op

Job Description: Want to work with the best and brightest in a company that takes on challenges Never Been Done Before? Emerson Process Management?s Process Systems and Solutions business has a great opportunity for a Automation Engineer Co-op to begin working in May 2014 through December 2014. We develop automation software to streamline manufacturing processes for Life Sciences companies. Responsibilities: You will have an opportunity to work in collaborative, problem solving teams responsible for engineering the automation behind some of the largest and most complex plants in the industry. As a Co-op, you will work alongside experienced automation engineers and will gain experience in all phases of a project, from requirements gathering to customer acceptance testing. This will require collaborating with customers from top companies in their industries. By interfacing with clients and fulfilling their process automation needs, you can have a direct impact on our business, our customer?s business, and be able to see tangible results from your work. Your responsibility for developing solutions to their automation needs will improve plant operation efficiency, resulting in higher quality products. We are looking for students who are interested in gaining real-world experience in this dynamic environment and who would like to establish a career with Emerson. Basic Qualifications: Co-op candidates MUST be entering their junior or senior year or a graduate level student at their college or university with a relevant/applicable engineering major (e.g. Chemical Engineering or Biomedical Engineering). Must be currently enrolled in an accredited college/university with at least 2 years of coursework completed within Engineering. Minimum GPA of 3.0 preferred Previous internship(s) a plus, but not required. Ability to reason through and conceptualize abstract problems. Ability to fast learn new technology on the fly. Good communication skills. Ability to work well with a team. Preferred Qualifications: Additional Information: Relocation benefits are not available for this position. About Emerson: Emerson is a global leader in bringing technology and engineering together to provide innovative solutions for customers in industrial, commercial, and consumer markets around the world. Founded in 1890 in St. Louis, Missouri (USA), Emerson delivers solutions through five business segments: Process Management, Industrial Automation, Network Power, Climate Technologies, and Commercial & Residential Solutions. With sales of $24.7B and more than 130,000 employees in over 150 countries, we have a customer-focused, results-driven culture where employee performance is recognized and rewarded. Emerson Process Management is a leader in helping businesses automate their production, processing and distribution facilities in key industries including chemical, oil and gas, refining, pulp and paper, power, water and wastewater treatment, metals and mining, food and beverage, and pharmaceutical. Running a process operation means constant pressure to cut costs, increase output, reduce energy use and emissions, and improve safety ? all while managing increasingly complex operations. Emerson?s Process System?s and Solutions business provides automation technology and consulting services to allow process manufacturers to make the most of their operations while reducing costs and minimizing safety and environmental risks. Today, our control systems run more than 10,000 plants in 135 countries around the world. Our customers rely on us to solve their toughest challenges, and it?s a commitment we take very seriously. Work Authorization: No calls or agencies please. Emerson will only employ those who are legally authorized to work in the United States. This is not a position for which sponsorship will be provided. Individuals with temporary visas such as E, F-1, H-1, H-2, L, B, J, or TN or who need sponsorship for work authorization now or in the future, are not eligible for hire. Equal Opportunity Employer: Emerson is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to sex, race, color, religion, national origin, age, marital status, political affiliation, sexual orientation, gender identity, genetic information, disability or protected veteran status. We are committed to providing a workplace free of any discrimination or harassment. If you have a disability and are having difficulty accessing or using this website to apply for a position, you can request help by calling 1-314-553-2544 (V/TTY/TDD) or by sending an email to . APPLY NOW! (You will be redirected to our applicant tracking system, where you will be required to create an account.)...

BMET Senior - St. Anthony (Pendleton, OR)

Job Summary: Sr Biomedical Engineering Technician This position administers the daily operations of a specific service shop and provides repair, incoming inspection, calibration and maintenance services to medical treatment and diagnostic equipment. Key Responsibilities: In conjunction with the Account Manger, interacts daily with hospital department managers, equipment users, physicians and administrative staff concerning service and usage issues. Communicates daily with Account Manager and effectively handles all service emergencies. Maintains life support equipment. Provides coverage and support for Account Manger during manager?s absence. Provides technical support and assistance to Clinical Engineering technicians. Repairs and maintains medical equipment under contract and performs BMET I and BMET II duties and functions as required. Maintains equipment repair records for medial equipment under contract. Assists in the ordering of parts and supplies necessary for the servicing of medical equipment. Provides input to the Account Manager regarding new service opportunities within a location serviced by the Clinical Engineering Division and performs other duties as assigned....

***Quality Engineering Leader/Manager***

Fortune 500 Medical Tech Company and Contract Manufacturer Fortune 500 Medical Technology Company is currently seeking a Quality Engineering Leader to support manufacturing operations at a state of the art medical device/pharmaceutical manufacturing plant in Eastern Nebraska. This is an excellent opportunity to join a well-respected and growing organization in medical device/pharmaceutical design and manufacturing. This position will have up to 10 direct reports: Duties/Responsibilities: -Manages team of quality engineers and validation engineer -Ensures compliance of the production documentation and practices -Provides technical input for projects (Tools ? FMEA?s, risk mitigation, validations, DOE?s, and other) -Oversees validation activities (new equipment, process, IQ/OQ/PQ) -Evaluates cause and effect of defects with manufacturing processes and products -Oversees/leads continuous improvement projects -Manages quality engineering activities -Reviews departmental budget and controls discretionary costs...

SR. Compliance Engineer

Description: Dynamic, strong-growth, global medical products manufacturer has an immediate opening for a Senior Compliance Engineer located in the Midland, TX, area. The Senior Compliance Engineer leads and maintains assigned compliance functions in accordance with the strategic goals of the company. You will ensure compliance with all Quality System standards and maintain/improve the Quality System to ISO level standards. Responsibilities include: 1. Ensure compliance to regulations and directives such as 21 CFR Parts 4-211 & 820, ISO 13485, MDD, CMDR, TGA and ANVISA requirements 2. Identify problems, examine solution options, implement action plans, and provide resources. 3. Participate in site internal audits as a team member or as lead auditor to ensure compliance with all applicable quality system standards. 4. Lead Quality Improvement Processes and Projects as assigned. 6. Serve on cross site project teams to improve overall quality systems performance and overall compliance 7. Follow all EHS requirments 8. Lead continuous improvement initiatives. 9. Lead and coordinate external audits for ISO 9001, 10. Conduct Quality Systems external audits and inspections....

Engineering Undergraduate Intern (SED-2015-146)

Engineering Undergraduate Intern (SED-2015-146) Applied Research Associates, Inc. is seeking a qualified candidate to support our BioGears ® Engine development project in Raleigh, NC. Join our multidisciplinary team developing tools for training medical personnel in clinical areas such as administering anesthesia and treating acute battlefield injuries. Our project team includes 10 software developers, scientists, and engineers with diverse backgrounds. We are developing the BioGears ® human physiology engine that will be used as a research tool to drive applications, simulate patient response during procedures or medical events and develop training tools for medical education. You will work with the project team to analyze and calibrate Pharmacokinetic and Pharmacodynamic (PK/PD) models. For more information see www.BioGearsEngine.com and www.HumanSim.com...

Clinical Project Manager

MED Institute, Inc. is currently accepting applications for a Clinical Project Manager to become a part of our growing clinical team. This position is responsible for coordinating global clinical studies on behalf of the Cook organization. Responsibilities Develop and maintain a working knowledge of FDA and other regulatory requirements that may impact global clinical studies including ICH GCP, JGCP and ISO 14155; Provide leadership in the development and review of study-related documents; Establish and maintain close working relationships with physicians, outside consultants and the study sponsor through exceptional communication on a regular basis; Provide review of invoices from study vendors, IRB approvals and informed consent documents, monitoring reports, etc.; Provide leadership in regularly scheduled study team meetings with both internal and external resources; Train the clinical project team, including investigators and site research staff, on the study protocol and use of the device; Act as a liaison between the study sponsor, clinical project team and investigators; Work closely with the Clinical Process Management and Clinical Science teams to develop and implement specific study plans and ensure that appropriate resources are available for the project; Participate in and conduct visits and meetings with investigative sites, physicians and consultants, as needed; Responsible for achieving study objectives by working with clinical project team members to set project priorities and milestones and resolve project conflicts; Track study metrics (progress) in order to manage investigative site and study team resources toward achievement of milestones; ensure Clinical Process Management and Clinical Science teams are appropriately informed in a timely manner to offer guidance in resolving the issues; Respond promptly and appropriately to study issues raised by investigative sites, sponsors, monitors and consultants; and Participate in the analysis, summarization and reporting of clinical data for regulatory or marketing purpose throughout the course of the study. Essential Qualifications A Bachelor?s degree with significant relevant experience is required. Masters degree in Health, Life Sciences or Biomedical Engineering, preferred. Previous experience in the conduct of clinical studies preferred, preferably in the medical device industry; Proven ability to exercise sound judgment in independent decision making; Conscientious, influential person with an outstanding work ethic and strong personal discipline; Ability to interact with physicians, scientists and company executives in a professional and personable demeanor in a variety of settings and interactions; Willingness and capability to handle multiple projects and responsibilities; Excellent organizational, leadership and problem-solving skills; Excellent written and verbal communication skills; Ability and desire to work in a collegial team atmosphere; including communicating and working constructively with colleagues; Sufficiently assertive to deal with confrontational situations; Experience in writing technical documents; and Willingness and ability to travel 25-50% of the time....

Clinical Engineering Specialist (Full Time, 80 biwkly, 1st shift)

RESPONSIBILITIES: This position provides quality, timely and cost effective preventative maintenance and repair service of the diagnostic imaging equipment....

Senior Network Engineer

Senior System Network Engineer To qualify for consideration you must live in the Dayton area, have at least an Associate?s Degree, are a US Citizen, and are tobacco free. Title: Senior Technology Network Engineer (with advanced level CISCO experience) Location : Dayton, OH Type : Direct hire (full-time) Travel : Must live in the Dayton area to be considered Office Hours : Must work on site Mon-Fri Start Date : Immediate Oleen is looking to hire an advanced Technology Engineer with data center networking and wireless experience. Education/Degree Requirements: Bachelor?s Degree w/6+ years job experience required or Associate?s Degree w/8+ years job experience is required. Degree in Computer Science, Business Administration, Electrical/Computer Engineering or related area. Related areas of study include Nursing, Medical Technology, Radiology, Mathematics, Engineering, Biomedical Engineering, Laboratory, Pharmacy, or Medicine. Certifications Requirements: Experience in 2 of the following 3: Telcom, Network, or Server. Completion of CCNP, MCSA, Nortel/Avaya, CCSP, CCDP, CWLSS, CCIE, MCSE, MCSM, VCPx-DCV, VCAPx-DCA, DCUCx, Imprivata, Storage, or equivalent certifications is preferred....

Research Engineer I, RIC Center for Bionic Medicine

General Summary The Research Engineer I under the general supervision of the assigned Research Scientist, evaluates need for, develops, fabricates, tests, installs, adjusts and maintains control systems and mechanical devices used for neural system research. The Research Engineer I consistently demonstrates support of the RIC statement of Vision, Mission and Core Values by striving for excellence, contributing to the team efforts and showing respect and compassion for patients and their families, fellow employees, and all others with whom there is contact at or in the interest of the institute. The Research Engineer I demonstrates RIC Core Attributes: Communication, Accountability, Flexibility/Adaptability, Judgment/Problem Solving, Customer Service and RIC Values (Hope, Compassion, Discovery, Collaboration, & Commitment to Excellence) while fulfilling job duties. Principal Responsibilities Collaborates with Research Scientist and other research staff regarding various project requirements. This process includes graphic representations, cost analysis, models and text, as needed, to communicate and execute the design. Provides the fabrication, installation, modification, repair and adjustment of devices. Participates in the maintenance of a safe work environment through adherence to policies and procedures relative to safety, fire prevention, hazard communications, security, equipment use and maintenance, infection control and vehicle safety. Assists with development, data collection, analysis and implementation relative to research and quality improvement activities. Reporting Relationships Reports directly to assigned Research Scientist or Principal Investigator....

Sr. Electrical Engineer

Job Classification: Full-Time Regular Connect confidentially with MRIGlobalMedDevice at: Our client is a growing medical device copany located in the Northeast region of the US. By joining their team, you can become part of a vibrant culture where you will have ample opportunity to reach your full career potential. This organization represents a means by which you can contribute to an intrinsically rewarding experience as a valued member of the team. Those who join this dynamic team will have a chance to introduce to the market the first of many revolutionary products!...

Validation Engineer II

Introduction: Is This The Role For You? We hire smart people with big hearts. People who have a passion for their work and who strive every day to help others. Our work requires bold and innovative leaders; people who bring strong values and ethics to their role. If you?re ready for a career that allows you to grow and develop into the professional you want to be ? today and in the future?.CryoLife is the place for you. Position Overview: Utilize Validation Engineering techniques to ensure that CryoLife complies with all applicable federal, industry and corporate procedures, guidelines and regulations for validation during the receipt, storage, manufacture and distribution of products. Responsibilities: Assist in the implementation of corporate policies and procedures relating to quality, project management, process development and Quality System Regulation/ISO compliance by periodically reviewing specifications for functionality and initiating the required changes, establishing procedures and integrated program plans for achieving reliability in accordance with specifications and procedures. Design, prepare, execute and analyze validations to approve equipment, processes and software used in the testing, processing, storing and distribution of products. Collect, statistically analyze and develop report packages to support validations and/or engineering studies. Develop, conduct and document qualifications/validations to ensure that the products processed are proven to be reliable, safe and effective prior to release. Coordinate validation activities, and scheduling, in support of corporate projects. Effectively complete other responsibilities that may be assigned....

Field Service Engineer - Laboratory Diagnostic Equipment

Company Overview As the world?s premier measurement company, Agilent works in close collaboration with engineers, scientists, and researchers around the globe to meet the communications, electronics, life sciences, and chemical analysis challenges of today and tomorrow. The company operates two primary businesses -- electronic and bio-analytical measurement -- supported by Agilent Laboratories, its central research group. Agilent is committed to providing innovative measurement solutions that enable our customers and partners-- the leaders in their felds -- to deliver the products and services that make a measurable difference in the lives of people everywhere. Learn More about Agilent Visit Our Company Website DAKO, an Agilent Technologies company Field Service Engineer - San Francisco/Sacramento, CA areas Position Summary In this position you will provide on-site repair, preventative maintenance, installation, sales support and modification implementation on all instrumentation. Insure that all regulatory, policies, and goals are met. Maintain customer relations and insure customer satisfaction with service. Complete all administrative duties as required. This position works directly on tissue diagnostic IVD medical devices in hospitals and laboratories. Responsibilities ?Respond to internal and external customer needs by providing repair, installation, upgrade and preventive maintenance activity on tissue diagnostic IVD devices. These devices contain a large amount of electro-mechanical, pneumatic, and hydraulic systems as well as computer hardware and software. ?Contact customers in a timely manner and schedules service efficiently. ?Communicate with manager and sales team to ensure customer needs and expectations are clearly understood and met. ?Maintain Dako?s customer service reputation by complying with all corporate policies and procedures. ?Complete administrative paperwork and computer reports promptly and accurately. ?Provide feedback to the Product Specialists, manufacturing or OEM vendors concerning performance anomalies encountered. Utilizes the complaint handling system as required. ?Document time and expenses in a timely manner as required in Oracle and other means as requested by manager. ?Responsive to customer requests for service and communicate proactively before, during and after service. % of Travel: 90-100% (Road Warrior) 4-5 days per week in the field visiting customers. There will be an average of 2 to 3 days per week requiring overnight stays. Territory will consist of San Francisco/Sacramento, CA and the surrounding areas. Position must be able to travel as needed to assist in other territories....

Software QA Engineer

Software Quality Assurance Engineer Valencia, CA POSITION SUMMARY: Responsible the design and development (including documentation and execut ion ) of software test and test automation framework and modu l es at the system and software component l evels . Participates in the deve l opment of corporate and/or organizational policies and procedures . Defines and executes on technology and architectural strategy using skills th at span a variety of domains including Mobile Apps (Android) , Cloud , Big Data Analytics , Web Services , and interf acing with embedded software for management and cont ro l of i nterconnected medical de vices. SPECIFIC DUTIES AND RESPONSIBILITIES: Works with developers and contract designers early in the requirements phase in a collaborative fashion to ensure system and software requirements are verifiable, quantifiable and unambiguous Generates test plans/protocols and builds test cases and test data sets based upon system and software requirements specifications Design prototype test framework, equipment and tools that support system and software component verification and validation processes. Responsible for the design and development of test automation framework by creatingand maintaining automated test scripts Coordinate and execute system level verification and validation tests according to approved test plan Develops test scenarios and provide support for user acceptance and compliance testing Writes test summaries and verification and validation test reports Uses defect tracking software to record problems Responsible for engineering and manufacturing documentation of test equipment and support systems Regularly participates in verification and validation test readiness and release readiness meetings Applies approved technical approaches to testing to ensure that systems and applications are evaluated in an analytical and systematic manner Knowledgeable (preferred) in the regulatory aspects of system verification . validation, and reporting. Must be able to work with all levels of users and management Must be confident working independently on a testing effort with minimal guidance, and as part of a team...

Medical Device Development Engineer

To be considered for this position, the ideal candidate must have a Bachelors of Science and a minimum of 5 years of relevant work experience; or a Master Degree with a minimum of 3 years of relevant work experience; or a PhD without experience; or equivalent work experience; or a Master Degree with a minimum of 3 years of relevant work experience; or a PhD without experience; or equivalent work experience. (Mechanical Engineering, Material Science, Plastics Engineering, or Biomedical Engineering preferred) Requirements: Knowledge of assembly techniques, bonding methods, materials, and processing equipment and techniques Additional experience with electronics, transducers, or signal processing, is preferred Experience with catheters and medical devices is REQUIRED Understanding of theories and principles of domain (preferably in a medical setting) Demonstrate organization and interpersonal skills working in a cross-functional, regulated environment Travel required to Rancho Cordova (15 %-20 %) Must be able to start June 1 st or earlier 3 month contract If you are eager to join a successful team and are interested in learning more about this position, please apply now!...

Manufacturing Engineer

Manufacturing Engineer Manufacturing Engineer for Advanced Ceramic Coatings, LLC. based in Hickory NC Role: We are seeking a Manufacturing Engineer in our Hickory, NC manufacturing facility. The successful candidate will possess experience in a manufacturing industry with increasing responsibilities in Engineering or Operations. He/she will be responsible for bringing new product and processes to market on time and within budget. Strong focus on process improvement and waste elimination in their responsible areas working closely with Production and Quality. He/she will apply techniques and processes, teach and mentor best practices (Lean, Six Sigma, DFM, DFA, DOE, FMEA, VA/VE, etc.). He/she must be available for one month training in Italy at the headquarters of the Unitedcoatings Group. Occasional overseas and domestic travel will be required to support the rapid growth of ACC. Company: The experienced professional will be employed by Advanced Ceramic Coatings, LLC. ACC is a recent joint venture between GE Aviation and Turbocoating Corp., one of the main companies of Unitedcoatings Group. Unitedcoatings Group is a world leader in the Thermal Spray industry and is active, through its different operating business units, in both European and American continents, with 3 main Divisions: Industrial Gas Turbine & Aviation, Biomedical, and Equipment. ACC is settled in Hickory (North Carolina) and is a leader in the ready-to-engine airfoil applications market, namely thermal spray coatings for Aviation components. The company was formed in November, 2014 and expects a very fast growth path that will lead to more than double the organization and the business in a short period of time. Key Responsibilities: The Manufacturing Engineer will initially report to the General Manager In this role, the candidate will be responsible ensuring all metrics for Safety, Quality, Delivery, and Cost for the organization are met and trending in the right direction Proper production preparation, quality, time accuracy, through the implementation of continuous improvement are key The responsibilities of the Manufacturing Engineer include but are not limited to the following: Act as lead technical reference for customer and internal organization in the case of materials, coatings, and assembly application Read, analyze, and discuss customer required specifications managing all qualification kick-off meetings and put decisions into actions Develop coating/post-coating processes based on Customer requirements Main focus is to create robotic programs, verify and interpret results in cooperation with the Metallographic Laboratory Production, and Quality Qualify new products/processes from kick-off to full release and continuously improve the existing ones Support production costs quotation and related feasibility study as needed Project leadership to continually decrease manufacturing costs Determine and approve the process standards of a new component, meet NPI qualification stage gates and milestones, and provide customer products corresponding to the required quality specifications Develop, check, and improve component standards in order to promote actions for cost savings and process standard improvement Participate in Root Cause Corrective Action activities to permanently eliminate defects Utilize 8D and DMAIC approach to problem solving and non-conformances Adhere to the Company's Quality and Safety Management System and in accordance with its procedures and requirements Utilize Lean and Six Sigma methods to improve Key Performance Indicators for Safety, Quality, Delivery, and Cost Participate in Kaizen events, promote positive employee environment, and community involvement...

Field Service Specialist

As a Field Service Specialist with Hamilton Company you will be tasked with providing high quality customer support through instrument installation, maintenance and troubleshooting. You will be responsible for performing: Responsible for new equipment installation at customer site Perform preventative maintenance Routine service and training for customers and internal employees Troubleshooting and repair of Hamilton equipment and subassemblies Serve as an industry leader in your assigned territory and provide backup support to other Field Service Specialists You may be tasked with providing customers with feedback regarding their Hamilton products to improve upon; safety, reliability, cost reduction and overall satisfaction A qualified Field Service Specialist will have: A high desire for quality Demonstrated experience working in the field as well as corporate setting Ability to train non-technical personnel on highly technical material Ability to operate company equipment and software applications for training purposes...

Process Development Engineer

Process Development Engineer Summary: Involved in the design, development, documentation and validation and of new customer products, and modification of existing products including defining requirements, timelines, and deliverables with a focus on prototypes, process development, design verification, clinical builds, training production, and preparation for process validation and manufacturing transfer of products. Responsibilities: Attends and arranges project meetings to discuss current and future design and development initiatives. May serve as a primary contact with clients on projects of low to moderate complexity. Assist with preparation of proposals and quotations for clients; interface as needed to resolve questions in a timely manner. Assist in preparation and maintaining of project plans to satisfy milestones, deadlines, budgets, and medical device quality regulations with required actions. Have input to project manager for tracking and communicate project status, plans, issues, timelines, action items, and budgets. Responsible for the following inputs: Feasibility builds, testing, and documentation. Equipment selection Process development and documentation Device verification samples and testing Operator training Process Failure Mode Effects Analysis Clinical builds Process validation Involvement in the full design, development and validation requirements of projects, including: Product design and specification creation, including mechanical and electrical component, assemblies and packaging Material sourcing and device prototyping Design verification and validation activities, including data for regulatory submission Manufacturing transfer and support of existing product lines as applicable Requirements: A Bachelors degree in Mechanical, Electrical, or Biomedical Engineering or a closely related engineering discipline and 2-5 years appropriate work experience. Experience in an engineering / manufacturing environment with mechanical, tool design, and manufacturing processes preferred. Must have excellent written and verbal English communication skills Strong computer skills, including the MS Office suite and MS Project. Must be able to fully interpret technical drawings, blueprints, specifications & illustrations. Strong analytical skills, must be able to obtain, evaluate, and apply secondary research information Ability to learn and apply new technology. Willingness to travel, if required....

Sr. Project Engineer

Overview: C.R. Bard is looking for a talented Sr. Project Engineer to support new product development and commercialization at our Bard Medical Division headquarters located in Covington, Georgia. Summary of Position with General Responsibilities: This position leads project teams and/or provides technical effort toward the development and introduction of new products into the medical device market. The position plays a key role in leading teams through the design development and FDA compliance pathway. The position requires an understanding of medical device markets. The candidate will interact with doctors and other medical professionals to ensure products meet user criteria. Essential Job Functions: ? As project leader guide team members through the design control process. Documents the new product development process; e.g., create specifications, define testing protocols, prepare comprehensive performance reports, and comply with QSR requirements. ? Manages complex project programs and sets direction for large technical efforts across multiple functional groups. ? Establish solutions to current user or device related issues. ? Assists in specifying performance criteria against which a candidate product design must be challenged. ? Interface with customers, doctors, and vendors regarding complex technical issues to meet device design criteria. ? Presents prototypes/proposed products in marketplace and draw conclusions relative to user attitudes/acceptance of the device/system. ? Present concise information as needed to Senior Management regarding progress of device development according to timelines and commitments....

Sales Engineer

Sales Engineer needed to plan medical product configurations to meet customer needs. To assess equipment needs and systems requirements. To collaborate with sales team and assist with sales promotion. To provide sales support, and secure/renew orders. Must develop and present product proposals to customers including industry-specific solutions. Applicant must have a Bachelors degree in Biomedical Engineering and 6 months of general sales experience. Mail Resume to: ATTN: Noe Roitman, HNM STAINLESS, LLC, D.B.A., HNM MEDICAL, 20855 NE 16 Ave., Suite C-15, Miami, FL, 33179. Source - Miami Herald...

ENVIRONMENTAL SERVICES FLOOR TECH

ENVIRONMENTAL SERVICES FLOOR TECH FUNCTION: To perform any and all duties as assigned to maintain the facility in a clean, sanitary, and orderly manner. POSITION SPECIFICATIONS: The following specifications may differ depending upon the number of available employees among whom the performance of a particular job function can be distributed and the size and type of community. Employees will be required to perform any other job related duties requested by their supervisor. Requirements are representative of minimum levels of knowledge, skills and /or abilities. To perform this job successfully, candidate will possess the mental abilities or aptitudes to perform each duty proficiently. All requirements are subject to possible modification to reasonably accommodate individuals with disabilities. ESSENTIAL FUNCTIONS AND RESPONSIBILITIES: To perform this job successfully, an individual must be able to perform each key function satisfactorily. Reasonable accommodations may be made to enable individuals with disabilities to perform the key functions. GENERAL MANAGERIAL FUNCTIONS Assists in the daily cleaning of patient areas, office areas, gyms, restrooms, public areas, meeting rooms or any or all areas of the facility with a positive attitude. Assists with cleaning of discharged rooms. Dusts furniture, equipment, woodwork, and dry and / or damp mop floors. Polish and clean fixtures in utility and restrooms. Safely uses vacuum cleaners according to operating standards. Clean lights, vents, baseboards, televisions, furniture, walls, closets, windows, doors, and any or all surfaces assigned. Empty / clean wastebaskets or other trash receptacles. Transport waste to specified area. Properly handles bio-medical waste. Transfers waste to specified area. Removes and replaces used needle receptacles and transports to specified area. Moves furniture and other heavy objects as required. Transports soiled linen to appropriate area. Performs special projects as assigned. Works effectively with the patients, visitors, and employees. Performs multiple floor care tasks using manual, electric, or battery powered equipment. Performs all other duties as assigned by supervisor. MAINTENANCE OF BUILDING / EQUIPMENT Maintains a safe, clean, sanitary, and orderly building and efficient environment of care to serve the needs of the patients, visitors, and employees. Operates all equipment in a safe manner and the only equipment utilized is that which previous training of use has occurred. Inspects housekeeping equipment for wear and tear, making recommendations for replacement or repairs. Tags out defective equipment properly and assures repairs are done. Maintains the ESD areas: Maintains supplies at par levels and arranges in an organized manner. ADHERENCE TO FACILITY PROCEDURES Procedures are performed according to established method in the procedure manual. Utilizes body substance precautions and other appropriate infection control practices with all activities. Follows safety guidelines established by the facility (i.e., electrical safety program). Adheres to departmental policies and procedures as well as the seven disciplines of the Environment of Care. Reports all accidents or incidents observed on the shift that they occur. DOCUMENTATION All accidents or incidents are recorded on an EOC tracking report form. Assists in the collection of all laundry documentation at least monthly or as appropriate. COMMUNICATION All changes or occurrences affecting the well being of the facility are communicated appropriately. Staff meetings are attended, if on duty. Minutes read and initialed if not on duty. Keeps current and integrates new information, communicates and models organization values and fosters high performance. PERFORMANCE REQUIREMENTS Decisions are made that reflect both knowledge and good judgment. Awareness of own limitation is evident and assistance is sought when necessary. Complies with Personal Appearance policy standards to include appropriate display of identification badge. Attends committee meetings (if assigned). Reports related to the committee are given during staff meetings. Takes responsibility for own professional growth. Attends and participates in all scheduled training, educational and orientation classes, programs and activities including annual mandatory classes. Follows work schedules and complete assigned tasks according to the established policies and procedures of the facility. Notifies the facility when late or absent from work. Adheres to attendance and tardiness policy. Demonstrates organizational ability and time management. Respects confidentiality of patient at all times (i.e., when answering telephone and / or speaking to co-workers or use of fax or electronic messaging.) Cooperate with inter-departmental personnel to ensure that the needs of the patient are met and maintained. HUMAN RELATIONS Demonstrates a positive working relationship with patients, visitors and facility staff. Acknowledges authority and responds appropriately to the direction of supervisors. Assists co-workers as needed. INTERPERSONAL SKILLS: Demonstrates active listening techniques, gains support through effective relationships, treats others with dignity and respect and seeks feedback. CONTINUING EDUCATION: Attends in-service and education programs and attends continuing education required for maintenance of professional certification or licensure. Incorporates new methods, principals and trends learned from continuing education programs into existing practices....

Senior Project Engineer

Siter-Neubauer & Associates is currently conducting a search for Senior Project Engineer: My Client is a Major Medical Device Manufacturer which is located in the Atlanta Area. The Company is a leader in products that focus on Disease State Management in three key areas: Vascular, Urology, and Oncology. We are looking for a Project Engineer with at least 4 years of experience in taking a product from concept to commercialization in the Medical Device Industry. The position plays a key role in leading teams through the design development and FDA compliance pathway. As project leader guide team members through the design control process. Documents the new product development process; e.g., create specifications, define testing protocols, prepare comprehensive performance reports, and comply with QSR requirements. . Manages complex project programs and sets direction for large technical efforts across multiple functional groups...

Research and Development Engineer

This position will invent, develop, and improve important commercial products for ATI for use in aerospace engine, airframe, oil and gas, and biomedical markets. Reports to Manager of Research and Development. Responsbilities: Conduct research to support development and improvement of Ti, Ni-base superalloy, and specialty steel products and powder metals. Become recognized metallurgical expert in an alloy class or manufacturing process. Utilize process simulation to support manufacturing process improvements that result in better product quality and lower manufacturing costs. Conduct testing and characterization in order to provide expert, timely materials solutions to customers. Provide technical marketing support to the Business Development organization through customer visits and targeted technical support. Propose and defend project concepts for new products, cost savings, quality improvement, and process innovation. Collaborate with technology and research colleagues across ATI. Communicate results to management, colleagues, and customers in the form of written reports and oral presentations. Maintain industry expertise and current knowledge of developments in Ti, Ni-base superalloy, or specialty steel metallurgy by experimentation, attending meetings and conferences conducted by trade associations, by reviewing trade literature and by periodic visits to customer or supplier base. ATI Metals and its subsidiary companies will provide equal employment opportunities to all applicants without regard to applicant?s race, color, religion, sex, gender, genetic information, national origin, age, veteran status, disability status, or any other status protected by federal or state law. The company will provide reasonable accommodations to allow an applicant to participate in the hiring process if so requested. #LI-MH1...

Sales Engineer - Semrock

Title: Sales Engineer - Semrock Business Unit: Semrock Location: USA-NY-Rochester Description: Semrock, Inc., A Unit of IDEX - based in Rochester, New York - develops and manufactures high-performance optical thin-film filters that set the standard for biotech and analytical instrumentation. Semrock is a rapidly growing company, with revenue from both the volume OEM sales of tailored products and the sales of standard catalog products to end-users. Semrock's optical filter products are set apart by their state-of-the-art performance and reliability. Major markets include filters for fluorescence-based systems, for Raman spectroscopy and for biomedical laser systems. Position Summary: Semrock is looking for an ambitious field sales person to join our Catalog Business, supporting entire North America. This is a unique opportunity for someone with a technical background who prefers to work closely with customers to understand their needs and grow business. This person should be passionate about supporting our customers and proactively identify and nurture repeat order opportunities from existing and new OEM accounts, as well as develop ways to grow business from research institutions. This person must be both resourceful and a team player, and is expected to develop into a key sales leader in an on-going aggressive corporate growth trajectory. Key Traits: Structured, organized and highly methodical - more process driven; provides (strategic) leadership to steer the ship; focused on value selling to win profitable business; will ensure goals remains on track. Essential Duties and Responsibilities: This person will lead sales efforts by broadening Semrock's business reach with new and existing OEM customers and research institutions in North America. The right person will learn how to properly qualify and prioritize new opportunities. This person will have the experience to sell at all levels within an account and will effectively broaden Semrock's business with key OEM customers and research institutions. A proven track record of selling optical components, and/or experience selling into the biotech OEM markets, is essential. Excellent project management as well as customer relationships management is essential for the success in this role. The successful candidate will quickly become comfortable with our highly technical products, as well as learn the use of traditional selling techniques. This person will be trained on Semrock product lines, technology and applications, in order to both qualify opportunities, as well as to support assigned OEM accounts and research institutions. This person is expected to have sales experience on how to sell at all levels of an account. The territory is the entire North America. This person should be located near a major airport, and be happy to travel up to 50% of the time. Qualifications: Qualifications: This person needs to be effective while working in a fast-paced, rapidly growing company environment. A strong customer orientation is essential. The right candidate will have a proven ability to quickly grasp new technical concepts. On a personal level, the candidate will exhibit the highest standards of integrity, and will be a team player. Semrock prides itself on its quality products and is looking for someone who will work hard to ensure full customer satisfaction. Education / Experience: Bachelor's degree in a technical or scientific field 1-3 years experience in Field Sales, Applications Engineering and/or Inside Sales Optical component or imaging instrumentation industry experience highly desired Reporting and Location: The position is based in North America (Work from Home) and will report to the Business Line Leader of the Catalog Business. IDEX is an equal opportunity employer Minorities/Females/Protected Veterans/Disabled...

Business Development Specialist - Plastics/Composites Technical Sales Engineer

Job Responsibilties: Air Liquide Industrial U.S. LP is seeking a Business Development Specialist- Advanced Materials Fabrication to: - Provide technical and marketing support to Air Liquide field sales organizations; - Develop technical solutions for customer process improvements with regard to non-metals advanced materials such as composites, plastics/polymers, ceramics, resins, and foams for industrial applications, particularly for aerospace applications; - Utilize technical expertise with polymer physics; - Evaluate aerospace customers' concurrent engineering and lean manufacturing practices as well as FAA regulations and ASTM standards; - Conduct flammability analysis of plastics and composites; - Examine injection molded plastic manufacturing processes; - Utilize knowledge of polymer applications in other industries, such as automotive or biomedical engineering; - Promote and present technologies and services to existing and potential customers to expand our business; - Utilize skills with computer programs such as ProE design software, Microsoft Office, Matlab, AutoCAD, C and C++ language programming, and 3Ds flash animation software in order to prepare detailed internal costs and benefits value based proposals leveraging our portfolio of advanced fabrication technology and service offers; - Lead technology demonstrations and implementations at customer's site; - Perform statistical analysis of customer process data and application results to ensure efficient development; - Maintain superior technical industry know-how by staying involved with professional organizations, attending relevant internal and external meetings, seminars, conferences and trade shows, and by preparing and presenting publications describing relevant technological developments; - Serve as liaison with application and research centers within the Air Liquide group as well as appropriate external research and professional organizations; and - Actively contribute to the safety and innovation culture of the company....

Quality Engineer ? Process Validation

PURPOSE AND SCOPE: Support 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. Provide guidance and support for Concord Quality Systems Process Validation activities including developing Test Method Validation protocols. Collaborate with all QS, ME, SE, Design QA, Ops and R&D Managers/SME?s to assure compliance and to develop validation plans, TMV protocols; analyze data, and the effectiveness of the quality management system validation process. Monitor process validation processes and TMVs to ensure strict accordance with product and process specifications The Quality Engineer Process Validation, QE-PV, position ensures that the products marketed and sold by Fresenius meet validation and regulatory requirements and our products are reliable, safe, produced and tested with all required TMVs. This position requires the individual to track Fresenius equipment from design stages through production and testing for Validation. The QE-PV will analyze potential equipment faults, sources, and initialize any required resolution. The QE-PV recommends test engineering improvements to the appropriate internal groups and/or outside vendors. The QE-PV will utilize his or her technical training and experience to implement necessary test engineering and or product testing protocols changes. Work with QEs, SQEs, CQEs and MEs and will ensure conformance with FDA and ISO regulations. DUTIES / ACTIVITIES: CUSTOMER SERVICE: Responsible for driving the FMCNA 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: As the Concord Quality Engineer- Process Validation, responsible to develop and maintain the Concord TMVs and align with Corporate QMS Validation strategy, VMP, MVP, policies and procedures Responsible for establishing standard and meaningful objectives for TMVs and metrics that align to goals, mission, and objectives for the Concord validation program Assure FDA/ISO Readiness for Concord QMS Validation policies and procedures and collaborate with Corporate to assure alignment and readiness. Maintain active role in industry organizations (AAMI, ASQ, etc.) Actively participate in Concord Validation Steering Committee for Validation program including all TMVs activities based on a Concord SMEs collaborative model including Technical Review Boards, as appropriate Collaborate with Concord SMEs and Corporate Validation SMEs to; Support and provide guidance in TMVs, audits, and validation issue resolution. Assure ?Best Practices? throughout the Concord Validation program Identify opportunities for improvement in PVs and TMVs areas and take an active role to change Assist/lead in problem solving sessions and solution based reviews Support the validation and optimization of new and existing products developed from scale-up to commercialization. Monitor process validation, TMVs and support IQ, OQ, PQ and PPQ to ensure strict accordance with documentation. Assure periodic review and trending (as appropriate) of the quality management system validation program; such as CAPA, complaints, nonconformance, and product/process. Must maintain knowledge and collaboration with Concord Managers/SMEs in areas of validations/qualifications.. Report on key performance indicators of Validation System's effectiveness to Concord Management, including Management Reviews Assure appropriate techniques for Process Validation and TMVs are in place and within compliance. Provide continuous PV and TMVs site level training, as needed to support compliance, sustainability and system effectiveness, including the maintenance of task-oriented role-based training for Process Validation, and the training of appropriate personnel on approved validation procedures. Other duties as assigned for Quality Engineer role....

Product Development Engineer

Job Functions : (Primary ?essential" duties and responsibilities) Design and development of medical devices and components through QSR requirements. Engineering tasks include technology development, development of requirements, preparation of technical drawings, product design and development, testing, process development, research investigation (literature, pre-clinical, and clinical studies), execution of design verification and validation, data analysis and report writing. Communicate results of development to team and management. Responsible for using good design control practices and processing change orders through Agile documentation system. Designs complex engineering tests and experiments, generates and executes protocols, and uses sound engineering design reasoning to make recommendations and solve complex problems. Responsible for analysis of data and record keeping within a lab notebook. Develop product and process including designing procedures for manufacturing and testing, including creating documentation, fixtures, and methods. Support ongoing production. Works well in a team environment and cooperatively with Customer Service, Sales, Marketing, Manufacturing, Regulatory and Quality on complex projects to ensure project success. Interfaces with outside suppliers including generating POs, tracking deliverables, and incoming receipt....

Senior Design Engineer - Mechanical - Medical

Senior R&D Engineer - Mechanical Design - Medical Devices Global Leader in the development and production of medical devices seeks R&D Engineers for concept generation, design and development of disposable and surgical medical device products. This company is expanding new product development and needs experienced design and development engineers! Austin, TX location will offer an eclectic smaller city environment, great cost of living and nice climate! The Senior R&D Engineer or Product Design Engineer will be focusing on the mechanical design and development of sterile, single-use, medical devices for minimally invasive surgical procedures. Senior R&D Engineer - Mechanical Design - Medical Devices Daily and Weekly Duties will be: ? Design, prototype, and develop innovative designs for use in new products for minimally-invasive and surgical products considering manufacturability (DFM), cost, quality, and reliability goals. ? Develop design control requirements including the creation of CAD models, assemblies, drawings, detailed specifications, design verification and validation plans, protocols and reports in accordance with FDA, MDD and ISO guidelines ? Lead and/or Collaborate closely and effectively with cross-functional departments ? Marketing, Quality, Regulatory and Manufacturing to drive projects to completion within schedule ? Manage the working partnerships with multiple outside resources contracted for the concept/product development, prototype/pilot fabrication, and testing of devices ? Identify, collaborate and manage outside suppliers on material selection, tool design, manufacturing technologies and specifications for components, subassemblies, finished assemblies ? Generate and document intellectual property (IP) ? Interact with Physicians and Surgeons to identify unmet user needs to improve product designs. ? Mentor and develop junior engineers...

Director of Plant Operations & Maintenance - Healthcare Facility

Vanguard Resources, a leading facility management company in the Southern region, is seeking a Director of Plant Operations for a small hospital in the Dallas, White Rock Lake area. The Director of Plant Operations and Maintenance will report directly to the COO of the facility, along with the COO of Vanguard Resources. Position responsibilities at this facility to include: Engineering Construction, Safety Security and Biomedical Engineering departments The Director of Plant Operations and Maintenance acts as the Vanguard point person responsible for ensuring Vanguard?s contractual responsibilities are met. This position is responsible for: ensuring delivery of world class customer service operational effectiveness, efficient labor and resource management, financial management, regulatory compliance, and controls. You will work with Vanguard Resources and our client to fulfill a valued role within a hospital setting to make sure that patients, visitors and staff receive the best possible experience. The ideal candidate will have four or more years? experience as a Director of Facilities/Engineering managing a maintenance department in a 100+ bed healthcare facility, along with technical knowledge of mechanical, electrical, & plumbing systems. The ideal candidate will have a minimum of a Bachelor?s degree. CHFM is a plus....

Senior Quality Assurance Engineer

Responsibilities: Independently plan, coordinate, and report on product quality programs, which provide a basis for sound technical decisions using techniques in experiment design and data analysis. Provide input to budget process and project schedules. Represent QA on development, current business or product improvement projects. Assure accuracy of product labeling and compliance. Generate, prepare and issue complex data for assigned quality reports. Coordinate complaint management activities and Customer Feedback failure investigations. Review, implement, or revise product, project, and program quality activities. Provide design review and risk assessment expertise. Approve the design, implementation, and schedule for QA projects. Recommend appropriate field actions to product regulatory committees. Accept/reject advertising, technical product, and support literature. Identify and/or perform vendor audit or site visits. Initiate, recommend, and provide training for QA personnel. Resolve issues of experimental design and data discrepancy in both intra and interdepartmental experiments. Beckman Coulter is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, national origin, religion, gender, age, marital status, disability, veteran status, sexual orientation, gender identity, or any other characteristic protected by law....

Medical Device Design Engineer / R&D Engineer

Engineer Today, Manager Tomorrow *** Positions in Harrisburg , 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 Electrical Engineering - 2 -10 years of medical device experience - Concept to Manufacturing - Innovative, fast moving company - SolidWorks, FEA, GD&T, Fluid Dynamics *** Positions in Harrisburg , PA ****...

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