Device Engineer II

Gilead SciencesFoster City, CA
2d$109,650 - $141,900

About The Position

We are seeking a motivated and detail‑oriented Device Engineer II for our Foster City, CA location to support the development and testing of Medical Devices and Combination Products (e.g., autoinjectors, pre‑filled syringes, needle safety systems, co‑packaged kits). This role focuses on executing device testing, supporting method development, and partnering cross‑functionally to advance programs from early development through commercialization.

Requirements

  • Strong problem‑solving abilities and independence in executing testing activities.
  • Proficient technical writing skills.
  • Working knowledge of design control principles, medical device regulations, and cGMP.
  • Familiarity with statistical techniques (e.g., Gauge R&R, normality testing, ANOVA) and statistical software (e.g., JMP, Minitab).
  • Master’s and 2+ years of relevant experience OR Bachelor’s and 4+ years of relevant experience

Nice To Haves

  • Hands‑on experience with mechanical testing, device characterization, or method development.
  • Experience with medical device testing, including test method development, validation, and design verification.
  • Proficiency with statistical tools and techniques (e.g., Gauge R&R, normality testing, data transformations, sampling strategies, ANOVA) and software (e.g., JMP, Minitab).
  • Experience using CAD software (e.g., SolidWorks, OnShape) and 3D printing for fixture or prototype development.

Responsibilities

  • Contribute to development activities across the device lifecycle, from concept through commercialization.
  • Support technical evaluation plans, including hands-on laboratory testing and oversight of contract lab activities.
  • Assist in developing, optimizing, and executing device test methods and characterization studies; support method validation with growing independence.
  • Perform and supervise bench‑level experiments, ensuring high‑quality data and adherence to internal procedures.
  • Collaborate on fixture, tooling, and prototype design using CAD and 3D printing.
  • Support design verification testing and method transfers to external labs or manufacturing sites.
  • Author technical documentation including test methods, protocols, reports, design control content, and regulatory submission materials.
  • Support quality investigations, CAPAs, and change controls for device testing.
  • Contribute to continuous improvement initiatives (e.g., 5S, Kaizen).
  • Communicate results, troubleshoot issues, and support technical alignment with Device Engineering, CMC, Quality, Regulatory, and external partners.
  • Present findings and study outcomes clearly to project teams and stakeholders.

Benefits

  • This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package.
  • Benefits include company-sponsored medical, dental, vision, and life insurance plans.
  • For additional benefits information, visit: https://www.gilead.com/careers/compensation-benefits-and-wellbeing
  • Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
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