Research And Development Engineer

Currently seeking an R&D Engineer for a premier leader in the Medical Device industry!

This is an onsite position in Minneapolis, MN – NOT a remote opportunity.

We are seeking a highly motivated R&D Engineer to join our Sustaining Engineering Group, supporting market-released disposable medical devices including catheters and introduction tools. This role focuses on design verification, test method validation, and product support rather than new product development. The ideal candidate will have a strong background in medical devices, with experience in design controls, engineering change orders, CAPA, and sustaining engineering practices.

Key Responsibilities:

• Provide R&D support for currently marketed cardiovascular catheters and related disposable devices.
• Review and process Engineering Change Orders (ECOs), Non-Conforming Material Reports (NCMRs), and CAPAs.
• Conduct design verification and test method validation within R&D, ensuring compliance with industry standards.
• Investigate customer complaints and propose design changes to address issues and improve cost-efficiency.
• Perform feasibility studies to verify product functionality and manufacturability.
• Collaborate with manufacturing teams to assess and implement design and process improvements.
• Coordinate with vendors to support development and sustaining activities.
• Maintain thorough design history documentation, including product requirements, risk management files, and verification/validation reports.
• Support ongoing regulatory compliance efforts, ensuring adherence to medical device quality standards (ISO 13485, FDA 21 CFR Part 820, etc.).

Qualifications & Experience:

• Bachelor’s degree in Mechanical, Biomedical, or Electrical Engineering, or equivalent work experience.
• 3 years of experience in R&D or sustaining engineering, preferably within the medical device industry.
• Strong knowledge of design controls, verification & validation, and regulatory compliance.
• Ability to work independently, manage multiple projects, and effectively problem-solve in a cross-functional team environment.
• Experience with CAPA, non-conforming materials (NCMR), and complaint investigations.
• Proficiency in engineering documentation, design history deliverables, and change management processes.
• Knowledge of medical device manufacturing processes and materials is a plus.