Biomedical Engineer Laboratory Services

Townsend & Associates
<< Go Back

  • Post Date: Apr 02, 2019
  • Start Date: 4/2/2019
  • Job Type: Contractor

Job Description

Biomedical Engineer Laboratory Services


  • 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


Biomedical Engineer Laboratory Services



  • 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

Want More Jobs Like This?