Biomedical Engineer II

Mounds View, MN 55112

Posted: 07/07/2025 Employment Type: Contract Job Category: Engineering Job Number: 620403 Is job remote?: No Country: United States

Job Description




Additional position details from the manager:
  1. Can you please confirm your top 3 skills sets required? Experience in a regulated industry. Knowledge of international and domestic regulations associated with biocompatibility.  Experience with assessing biocompatibility risk per ISO 10993 standards.
  2. Can you please confirm the 3 main responsibilities/day to day activities required for this role? Design and execute biocompatibility assessment plans and reports in accordance with ISO 10993 and regulatory requirements. Support product development lifecycle activities, including design changes and post-market surveillance, from a biocompatibility perspective.  Interface with laboratories to coordinate testing activities, ensure compliance, and resolve any technical issues.
  3. What is your target years of experience? 5+ years

The individual in this position is responsible for evaluating the safety and compatibility of medical devices with biological systems.  The role involves planning and placing biocompatibility testing in accordance with ISO 10993 standards, regulatory guidelines, and risk assessment principles.  This individual collaborates with cross-functional teams to ensure materials meet safety requirements.  This individual analyzes data, prepares technical reports, and supports regulatory submissions.  This position may also be involved in developing strategies for new products and addressing biocompatibility related issues during product development and post-market activities.

POSITION RESPONSIBILITIES:
  • Design and execute biocompatibility assessment plans and reports in accordance with ISO 10993 and regulatory requirements.
  • Interface with laboratories to coordinate testing activities, ensure compliance, and resolve any technical issues.
  • Review and interpret laboratory test results; document findings in technical reports and regulatory submissions.
  • Support product development lifecycle activities, including design changes and post-market surveillance, from a biocompatibility perspective. 
  • Stay current with evolving global biocompatibility standards, guidance documents, and regulatory expectations to ensure ongoing compliance.
TECHNICAL SKILLS
Must Have
  • Bachelor's degree in materials science, chemical engineering, biocompatibility or a related technical field. Advanced degrees will also be considered.
  • Experience in a regulated industry.
  • Knowledge of international and domestic regulations associated with biocompatibility.
  • Knowledge of materials and interactions with the body and environment.
  • Knowledge of Microsoft applications (Excel, Word, Outlook)

Nice To Have
  • Demonstrated problem solving and critical thinking skills
  • Effective verbal and written communication skills
  • Technical understanding of the effect processing has on material properties and performance
  • The ability to work well under pressure
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About Mounds View, MN

Ready to kickstart your career in the beautiful city of Mounds View, Minnesota? This vibrant area nestled in the Land of 10,000 Lakes offers a perfect blend of small-town charm and big-city opportunities. Known for its lush green spaces like Long Lake Regional Park and Rice Creek Chain of Lakes Park Reserve, Mounds View provides a scenic backdrop for professional growth. With easy access to Minneapolis and St. Paul, job seekers can enjoy the best of both worlds - from catching a game at U.S. Bank Stadium or Target Field to exploring the Walker Art Center or catching a show at the Guthrie Theater. Join us in Mounds View, where exciting job opportunities await amidst a backdrop of natural beauty and cultural richness. Explore our listings today and take the first step towards a rewarding career in this charming Midwestern gem.