• Design Control Engineer

    Insight Global (Blue Ash, OH)


    Job Description

    Our Medical Device client is seeking a Design Control Engineer to support product development activities and ensure compliance with Quality Management System (QMS) requirements and regulatory standards. This role involves performing hands-on testing as needed, executing verification and validation (V&V) protocols to confirm product design meets specifications, and preparing and maintaining design documentation and technical reports. Responsibilities include routing documentation for review and approval, maintaining accurate records, and interpreting technical drawings to support design and testing activities. The position requires applying QMS principles and design control knowledge throughout the product lifecycle while collaborating closely with the design technical lead to ensure adherence to applicable standards. Candidates should have a bachelor’s degree in engineering or a related field, experience with design control processes and QMS in a regulated environment, familiarity with V&V methodologies, and strong organizational skills. Preferred qualifications include knowledge of ISO 14971 risk management, CAPA processes, document control systems, and hands-on testing experience in the medical device or similar industry.

     

    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

     

    -PLM Experience required

     

    -Experience running a technical design change and new product release

     

    -Experience with CAD, drawing, report writing, design documentation, protocol writing, data analysis, hands on testing experience (preferred)

     

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

     

    -Experience with Windchill