# Device Engineer III

Hiring organization: [Gilead Sciences](https://career.thegoodapps.co/organizations/gilead-sciences)

Canonical page: https://career.thegoodapps.co/jobs/a807163d-d552-468a-8d74-5f5c5b60af06

Listed on Gilead Sciences's own careers site. Applications go to them directly.

- Seniority: Senior
- Location: United States - California - Foster City
- Salary: 117895 – 152570 USD per year

## Summary

This role supports the commercial lifecycle of combination drug-device products, handling design transfer, regulatory compliance, and post-launch engineering activities. It suits engineers with medical device manufacturing experience who want to work on established products rather than early-stage development.

_Our summary, not Gilead Sciences's wording._

## Skills named

Change Management, Design of Experiments (DOE), ISO 13485, Onshape, Risk Management, Root Cause Analysis, SolidWorks, Statistical Analysis

## Required

- 5+ years relevant experience with BS/BA, or 3+ years with MS
- Medical device development and manufacturing per ISO 13485
- Risk management per ISO 14971

## Nice to have

- Root cause analysis, deviation management, and investigations
- Lifecycle change control for combination products
- Complaint management experience
- Vendor and contract manufacturer collaboration
- Process characterization study design and execution
- Design transfer to manufacturing sites
- Knowledge of mechanical assembly for injection/delivery systems
- CAD experience with Solidworks, Onshape, or Fusion 360
- ICH Q7, Q8, Q9, Q10 familiarity
- Project management methods and tools
- Basic statistical methods including design of experiments and statistical tolerancing

Apply on Gilead Sciences's site: https://gilead.wd1.myworkdayjobs.com/en-US/gileadcareers/job/United-States---California---Foster-City/Device-Engineer-III_R0053812-1