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Engineer

3 months ago

North Haven, United States Redbock - an NES Fircroft company Full time

Quality Assurance Technician/Engineer 1


Summary:

This position will serve the role of Engineer I for device development of the client’s products including continuous product improvement. The candidate will support technical design and development activities for device and combination products and assist the technology transfer.


Duties/Responsibilities:

  • 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.


Skills/Requirements:

  • Bachelor’s degree in engineering (Biomedical, Chemical, Mechanical, or Electrical Engineering)
  • 1 to 3 years’ experience in laboratory.
  • Experience with injector-based combination product preferred.
  • Experience in design control activities.
  • Knowledge of primary containers and drug delivery.
  • 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).