Biomedical Engineer, Design Assurance

Job Description

Job Description

What You’ll Do:

The Biomedical Engineer, Design Assurance, is part of the product design and development team and ensures quality and regulatory compliance throughout the medical device lifecycle for class I and II reusable surgical instruments and disposable medical devices, and supports the implementation and management of the digital requirements management system. This position reports to the Director of R&D Engineering.

40% Lead Design Assurance For Representation & Compliance

• Represent product quality and compliance in new product development and sustaining engineering projects.

• Ensure design and process controls meet regulatory and customer requirements.

• Implement medical device requirements management software (Jama) to organize and effectively manage the company’s design and development files.

• Create and update controlled documents (QSPs, specifications, methods) within the Quality Management System.

30% Product Testing

• Develop and execute implementation, inspection, and test plans for design transfer.

• Support R&D with verification/validation protocols, specifications, and reliability testing.

• Coordinate external validation activities (e.g., mechanical, functional, biocompatibility, sterilization).

20% Risk Management & Reviews

• Lead risk management activities (FMEA, hazard analysis, FTA, statistical analysis).

• Participate in design reviews and change control processes.

20% Technical Guidance & Design Principles

• Provide technical guidance on product quality attributes.

• Apply Design-to-Cost and Design-for-Manufacturability principles.

The Experience, Skills and Abilities Required:

• Bachelor of Science in Mechanical Engineering or Biomedical Engineering

• Minimum of 3+ years design assurance or product development.

• Understanding of ISO 13485 and FDA 21 CFR 820 compliance.

• Experience with full design lifecycle and phase-gate processes.

• Understanding of FMEAs, DOEs and Risk Assessment methods

• Strong written and verbal skills for documentation, presentations, and team alignment.

• Problem-Solving & Critical Thinking: Analytical skills to identify gaps, assess risks, and draw conclusions.

• High degree of accuracy in documentation and reviews.

• Working effectively in cross-functional teams (design, manufacturing, regulatory).

Preferred Experience, Skills and Abilities:

• Experience in medical devices

• Jama Connect requirements management software

• Minitab statistical analysis software

• Knowledge of quality methodologies (Six Sigma, DFSS, DMAIC).

• Project Management, time management, prioritization, and execution.

• Leadership, mentoring, and fostering a quality culture.

This position is based out of our corporate office, south of downtown St. Paul. We welcome an on-site work environment Monday through Friday.

Compensation

We are committed to equitable and transparent pay practices. The salary range for this position is $77,700 - $124,400, representing the minimum and maximum of our compensation structure. Starting pay will typically fall between these values and is determined based on factors such as relevant experience, skills, and internal equity. Offers near the higher end of the range are reserved for candidates with exceptional qualifications.

Comprehensive Benefits Offerings

- Medical, Dental, and Vision Insurance

- Group Life Insurance

- Short-Term Disability Insurance

- Long-Term Disability Insurance

- 401(k) Plan with Company Match

- Workers' Compensation

- Employee Assistance Program (EAP)

- Regular Part-Time Benefit Eligibility

- Training and Development Program

- Tuition Assistance Program

- Paid Time Off, including holidays, floating holidays, vacation and Earned Sick and Safe Time (ESST)