Device Engineer II

Role Summary

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.

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.

Qualifications

• Required: Master’s and 2+ years of relevant experience OR Bachelor’s and 4+ years of relevant experience.
• Preferred: 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.

Skills

• 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).

Education

• Master’s degree with 2+ years of relevant experience or Bachelor’s degree with 4+ years of relevant experience.