• Design Control Technical Lead

    Insight Global (Raritan, NJ)


    Job Description

    One of our large Medical Device clients is seeking a seasoned Design Control Technical Lead to drive the technical execution of a design change project for a urinary catheter device. This role is ideal for a Senior/Staff level R&D engineer with deep expertise in design control, medical device regulations, and mechanical engineering processes such as extrusion and injection molding. This individual will lead the technical aspects of a design change project and oversee design control documentation and ensure compliance with regulatory standards. They will manage verification and validation activities, including risk assessments and test method development, coordinate with cross-functional teams and external vendors to implement new manufacturing methods and resolve yield issues. They will also support logistics and supplier onboarding to ensure readiness for design control execution and collaborate with project managers focused on scheduling, while owning the technical delivery and design control strategy.

     

    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

     

    -5-10+ years of experience within design control for Medical Devices

    -ADAPTIV experience

    -Experience running a technical design change

     

    -Experience managing vendors

     

    -Mechanical engineering background; experience with manufacturing processes, extrusions, injection molding -Experience working with Class II and III devices