Sr. Device Engineering , Device Engineering
Job in
Foster City, San Mateo County, California, 94420, USA
Listed on 2026-02-14
Listing for:
Gilead Sciences, Inc.
Full Time
position Listed on 2026-02-14
Job specializations:
-
Engineering
Biomedical Engineer, Quality Engineering, Medical Device Industry, Validation Engineer
Job Description & How to Apply Below
* Bachelor’s or Master’s degree in
** Mechanical Engineering**,
** Biomedical Engineering**,
** Chemical Engineering**, or related field.
* Hands‑on experience with: +
** Test method development and validation** +
** Design verification testing** +
** Characterization and performance testing
** for combination products.
* Understanding of
** design control**,
** risk management**, and regulatory standards (FDA, ISO 13485, ISO 14971, cGMP).
* Familiarity with relevant ISO standards (e.g.,
** ISO 11040**,
** ISO 11608**,
** ISO 80369**).
* Experience with statistical techniques (e.g., ANOVA, Gauge R&R, sample size calculations) and statistical software (JMP, Minitab).
* Strong communication skills, with the ability to write clear and concise technical documents.
* Demonstrated ability to troubleshoot, conduct root‑cause investigations, and drive continuous improvement.
- Experience in
** combination product development**, medical device testing, or pharmaceutical/biotech environments.
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