Engineer II, Sustaining - Wayne, NJ
Posted on: May 16, 2022
The primary responsibility for the Sustaining Engineer II position
focuses on Design Verification and Validation activities,
supporting 510K testing for submissions, CAPA execution, writing
and executing Test Method Validations, and working with component
suppliers. This position will report to the Sustaining Engineering
- Write and execute protocols, such as Design Validations or
Verifications. Compile, analyze and report protocol test data.
- Write and execute Test Method Validations. Compile, analyze and
report testing data.
- Update Design Specifications, Risk Management Plans and
- Investigate and plan CAPA activities
- Communicate and Coordinate activities with other Getinge sites
and outside component suppliers.
- Implement documentation changes as needed. (Engineering
specifications, change notices, manufacturing procedures, equipment
registrations and other documentation).
- Comply with Quality System Procedures, Good Lab Practices, and
Exposure Control Plan.
- Bachelor of Science degree (or equivalent), preferably in
Biomedical, Mechanical or Manufacturing Engineering with 2-4 years
of related experience.
- General understanding of Good Manufacturing Practices, FDA
regulations, and ISO requirements.
- Experience with process and equipment
Getinge is an equal opportunity employer and all qualified
applicants will receive consideration for employment without regard
to race, color, religion, sex, sexual orientation, gender identity,
pregnancy, genetic information, national origin, disability,
protected veteran status or any other characteristic protected by
Keywords: Getinge, Wayne , Engineer II, Sustaining - Wayne, NJ, Engineering , Wayne, New Jersey
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