Device Engineer III

Gilead Sciences • Foster City, CA

1d

About The Position

We are seeking a highly skilled and proactive Device Engineer III to support testing, method development, design verification and method transfer activities for medical devices and parenteral combination products, including autoinjectors, prefilled syringes, and needle‑safety systems. This individual contributor role is ideal for an engineer with strong technical fundamentals, hands‑on testing experience, and the ability to collaborate effectively across development, quality, and manufacturing teams. The position will be part of the Device Engineering group and sits within the Verification and Testing team supporting internal lab operations, design verification, external testing activities, and method transfer to manufacturing sites.

Requirements

• Doctorate OR Master’s and 3+ years of relevant experience OR Bachelor’s and 5+ years of relevant experience

Nice To Haves

• Bachelor’s or Master’s degree in Mechanical Engineering, Biomedical Engineering, Chemical Engineering, or related field.
• Experience in combination product development, medical device testing, or pharmaceutical/biotech environments.
• 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.

Responsibilities

• Support design control activities, including design verification, design transfer and risk‑management deliverables.
• Develop, optimize, and validate test methods for device and combination‑product components.
• Execute design verification (DV) testing and prepare protocols, data summaries, and technical reports.
• Assist with method transfers between internal labs, external DV labs, and manufacturing sites.
• Coordinate and monitor external testing, ensuring methods, protocols, and data meet quality and compliance standards.
• Contribute to lab operations, including equipment readiness, sample coordination, and maintaining 5S/Kaizen practices.
• Support quality investigations (e.g., deviations, CAPAs, change controls) related to testing activities.
• Represent the Device Engineering function in internal meetings, supplier interactions, and project team forums.
• Communicate technical findings clearly with cross‑functional partners.

Benefits

• company-sponsored medical, dental, vision, and life insurance plans

What This Job Offers

• Job Type: Full-time
• Career Level: Senior