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Sr Engineer

  • Location: Irvine
  • $ Salary: US$54.00 - US$59.00 per hour per hour
  • Job Type:Contract

Posted 12 days ago

  • Sector: Life Sciences
  • Contact: Yasmin Sweeney
  • Duration: 3-months
  • Start Date: ASAP
  • Expiry Date: 12 October 2023
  • Job Ref: JN -092023-481469

Job Description:

A leading Medical Device company are actively seeking a motivated candidate to fill their Sr Engineer role. This is an initial 3-month contract role with opportunity to extend/ convert to FTE.

This is an onsite role based in Irvine, CA with travel of up to 25% included. Full- time standard office hours. Salary range between $58-63 /hour depending on experience.


  • B.S. degree in Mechanical, Biomedical engineering or related and 5-7 years experience required.
  • Demonstrated engineering experience in Supplier Quality, Supplier Development, New Product Development, or Manufacturing Engineering in medical device or other regulated industry.
  • Knowledge of complex catheter and implant manufacturing preferred.
  • Experience with the use of statistical techniques, Six Sigma tools, and DMAIC problem solving techniques.
  • Knowledge and understanding of FDA's 21 CFR Part 820, ISO13485, ISO9001, and other International Regulatory Standards preferred.


  • Support component specification development, identification of critical features, development of inspection methods and plans, test method validation, and component capability assessments.
  • Lead risk management activities, including the development and implementation of FMEAs, process control plans, and quality agreements at suppliers.
  • Support suppliers in the development, approval and execution of process validation protocols and reports for critical processes.