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Enigneer/Lab Technician

2 months ago

New Haven, United States Talent Space Full time

Talent Space, Inc. is seeking a Engineer/Lab Technician for a contract opportunity in New Haven, CT

Responsibilities:
Support technical design and development activities for device and combination products and assist the technology transfer.

  • Manage medical device test method and specification development, including test method development, validation, transfer, and life cycle management.
  • Support the laboratory operation such as sample inventory, equipment qualification and maintenance.
  • Conduct characterization for device function, assembly, manufacturability, etc. using both CAE and traditional engineering techniques.
  • Test mechanical or electromechanical systems on bench top models or production representative units, during design development and verification.
  • Consult with third parties such as specialist manufacturers and toolmakers.
  • Communicate effectively, both verbally and in writing, internally across departments and with external suppliers.
  • Comply with the Company's quality assurance requirements as well as applicable regulatory requirements.

Required Skills:
  • Bachelor's degree in Engineering (Biomedical, Chemical, Mechanical, or Electrical Engineering) plus 1-to-3-year experience in laboratory. (preferred)
  • Experience in design control activities.
  • Understanding of mold, fixture design and build as well as application of validation processes (IQ/OQ/PQ).
  • Interface with the medical device vendor and tooling company.
  • Knowledge of the regulatory and compliance requirements of device design controls and combination products (i.e. FDA QSR 21 CFR Part 4 and 820/ISO13485 quality system requirements).
  • Manufacturing, device design, fixture design experience
  • CAD - Computer aided design - Solidworks software