• Staff Design Verification Engineer

    Insight Global (Irvine, CA)


    Job Description

    We’re supporting a fast-growing, mission-driven medical device company in the diabetes-technology space that is building next-generation wearable insulin-delivery systems. They are looking for a hands-on Design Verification Lead to drive verification activities for their patch-pump program and help shape the rigor, reliability, and quality of a life-changing Class II/III medical device. In this role, you’ll lead DV planning and execution, develop and improve test methods, manage test samples and external lab coordination, and oversee day-to-day test-lab operations. You will work closely with mechanical design, quality, and reliability teams to root-cause issues, interpret data, and ensure test methods accurately reflect design intent. This is a highly visible, high-impact position for an engineer who thrives in regulated environments and enjoys both leading and being hands-on in the lab.

     

    We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to [email protected] learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.

     

    Skills and Requirements

     

    - 8-10+ years of experience in mechanical engineering, design verification, or test engineering within a regulated medical device environment.

     

    - Strong experience developing, executing, and improving design verification test methods and troubleshooting test failures.

     

    - Hands-on lab experience, including running tests yourself (not just managing technicians), performing root-cause analysis, and maintaining lab equipment/processes.

     

    - Proven ability to manage technicians, test samples, external labs, and day-to-day DV workflows end-to-end.

     

    - Deep familiarity with relevant medical device standards (e.g., ISO 13485, ISO 10993) and understanding how they impact DV requirements.

     

    - Strong communication and collaboration skills with design, quality, and cross-functional engineering teams.

     

    - Highly organized, reliable, and comfortable operating with a “service mindset” in support of product development teams. - Experience with wearable, implantable, or drug-delivery devices.

     

    - Exposure to biocompatibility, packaging validation, or sterilization testing.

     

    - Background or coursework in biology or life sciences.

     

    - Prior experience in a Staff or Senior-level DV role leading technicians or owning a full DV program.