Device Engineer III
Gilead Sciences
August 19, 2026
Remote friendly (San Francisco Bay Area)
United States
Operations
Job Description: Device Engineer III supporting drug-device combination products across the commercial lifecycle, including commercialization and sustaining engineering from design transfer through ongoing support. Requires expertise in design controls, risk management, change management, and complaint management.
Job Responsibilities:
- Represent Device Development on commercial CMC and business continuity teams; communicate technical findings and project updates.
- Implement post-launch changes; support complaint handling and investigations; investigate and close out deviations.
- Perform risk management reviews/updates per ISO 14971.
- Maintain the Design History File (DHF) throughout the commercial lifecycle.
- Support business continuity (including second sourcing).
- Support manufacturing site selection and other late-stage development activities.
- Execute design transfer activities to internal/external manufacturing sites.
- Author, review, and approve technical documentation (design control records, test methods, protocols, reports, risk management documentation).
Knowledge & Skills:
- Medical device development/manufacturing per ISO 13485; risk management per ISO 14971.
- Root cause analysis, deviation management, investigations; lifecycle change control for combination products; management of combination product complaints.
- Work with vendors/suppliers/contract manufacturers to implement changes or investigate performance issues.
- Design, execute, and statistically analyze process characterization studies.
- Especially well qualified: design transfer; familiarity with mechanical assembly processes for drug injection/delivery systems; Solidworks/Onshape/Fusion 360; ICH Q7/Q8/Q9/Q10; project management tools; basic statistics (DOE, components of variance, statistical tolerancing).
Education & Experience:
- 5+ years relevant experience with BS/BA; or 3+ years with MS.
Benefits:
- May be eligible for discretionary annual bonus, discretionary stock-based long-term incentives, paid time off, and benefits package (company-sponsored medical, dental, vision, life insurance).
Application instructions:
- Apply via the Internal Career Opportunities portal in Workday.
Job Responsibilities:
- Represent Device Development on commercial CMC and business continuity teams; communicate technical findings and project updates.
- Implement post-launch changes; support complaint handling and investigations; investigate and close out deviations.
- Perform risk management reviews/updates per ISO 14971.
- Maintain the Design History File (DHF) throughout the commercial lifecycle.
- Support business continuity (including second sourcing).
- Support manufacturing site selection and other late-stage development activities.
- Execute design transfer activities to internal/external manufacturing sites.
- Author, review, and approve technical documentation (design control records, test methods, protocols, reports, risk management documentation).
Knowledge & Skills:
- Medical device development/manufacturing per ISO 13485; risk management per ISO 14971.
- Root cause analysis, deviation management, investigations; lifecycle change control for combination products; management of combination product complaints.
- Work with vendors/suppliers/contract manufacturers to implement changes or investigate performance issues.
- Design, execute, and statistically analyze process characterization studies.
- Especially well qualified: design transfer; familiarity with mechanical assembly processes for drug injection/delivery systems; Solidworks/Onshape/Fusion 360; ICH Q7/Q8/Q9/Q10; project management tools; basic statistics (DOE, components of variance, statistical tolerancing).
Education & Experience:
- 5+ years relevant experience with BS/BA; or 3+ years with MS.
Benefits:
- May be eligible for discretionary annual bonus, discretionary stock-based long-term incentives, paid time off, and benefits package (company-sponsored medical, dental, vision, life insurance).
Application instructions:
- Apply via the Internal Career Opportunities portal in Workday.