Biomedical Engineer Laboratory Services

Townsend & Associates
US-MD-Columbia
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  • Post Date: Apr 02, 2019
  • Start Date: 4/2/2019
  • Job Type: Contractor

Job Description

Biomedical Engineer Laboratory Services


Responsibilities:

  • Manage the sites Biomedical Technology's mechanical research laboratory whose primary role is to evaluate combination drug delivery systems through the use of sound, safe and justifiable scientific methods
  • Develops evaluates and tests concepts, prototypes and ideas for new products and product improvements
  • Utilize cGLP's in its daily activities such that samples are tracked, tested/evaluated and technical memos or reports are written and supplied to the site Product Development and where applicable Quality, Technology and Manufacturing groups
  • Responsible for adhering to design controls and documenting all product development work in a Design History File
  • Manage a Combination Product laboratory to comply with cGLP's
  • Ensure staffing levels are adequate to support test requirements
  • Ensure laboratory equipment is in compliance with company requirements and maintained by the lab staff
  • Manage an appropriate documentation system to comply with company standards and where appropriate cGMP's
  • Manage sample control through utilization of a system to ensure all samples are logged in and stored in a controlled manner
  • Manage the laboratory's staff to use appropriate SOP's, guidances and risk assessment files in the testing/evaluation of samples
  • Manage the laboratory and staff to meet all company/site Safety standards - EHS
  • Manage the laboratory staff to evaluate Product development and where appropriate Complaint, Manufacturing and auto-injector defect samples.  Ensure that the staff creates thorough and comprehensive evaluation reports with concise summaries explaining the lab's findings
  • Conduct testing where needed
  • Manage the staff to create technical reports
  • Review and approve laboratory memos and technical reports
  • Supervise up to 2 to 4 direct & indirect reports including FTEs & contingent workers, Junior Engineers or Technicians
  • Oversee engineering work conducted by Associate Biomedical and Biomedical Engineers
  • Provide training for new hires or contractors and oversee work conducted by contractors or lab technicians

Biomedical Engineer Laboratory Services

Skills

Biomedical Engineer Laboratory Services

W2 ONLY!!! NO CORP TO CORP

Qualifications:

  • B.S. Degree in Engineering discipline with 12+ years’ experience OR M.S. Degree in Engineering discipline with 9 years’ experience OR Ph.D. in Engineering discipline with 7 years’ experience (Biomedical Engineering or Mechanical Engineering required)
  • Conceptual design skills and experience with a variety of manufacturing methods (e.g. injection molding, machining, etc.) preferred
  • Experience in Human Factors and usability engineering preferred
  • Strong skills in design software (preferably Solidworks) and other general computer software such as word processing, spreadsheets, presentations, etc. preferred
  • Strong laboratory skills such as component inspection or failure analysis, mechanical testing, etc. preferred
  • Strong mathematical, analytical, and reasoning skills preferred
  • Strong problem-solving skills preferred
  • Strong creativity and innovation skills preferred
  • Strong creativity astuteness preferred
  • Strong research skills preferred
  • Experience in complying with FDA Design Control Regulations for Combination Products per 21 CFR Part 4 and/or Medical Devices per 21 CFR 820.30 and EU Medical Device Directives preferred
  • Ability to prioritize multiple responsibilities and to work on multiple projects simultaneously preferred
  • Business acumen – demonstrates knowledge of market and competition preferred
  • Responds to requests for service and assistance with professionalism, courtesy, and confidence preferred
  • Laboratory management experience preferred
  • Capable of working independently with minimal supervision preferred
  • Strong presentation skills preferred
  • High level of attention to detail and accuracy preferred

Biomedical Engineer Laboratory Services

Contact Details

Ph: 973-984-7900



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