Biomedical Engineer, Design Assurance

Scanlan International, Inc., is a medical device company specializing in the highest-quality surgical instruments. Now in our fourth generation, the Scanlan family continues its dedication to providing the best surgical instrumentation available anywhere in the world. We are seeking a Biomedical Engineer, Design Assurance professional to join our organization and continue this commitment.

What You’ll Do:

The Biomedical Engineer, Design Assurance professional 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)

How to Apply?

Scanlan International, Inc. accepts online applications at https://www.scanlaninternational.com/contact-us/careers/

Applicants with disabilities who need accommodation to complete the Scanlan International, Inc. application process should contact Human Resources at 1.800.328.9458 or email hrteam@scanlangroup.com.

Scanlan International is an EEO employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as protected veteran.

Our company uses E-Verify to confirm the employment and eligibility of all newly hired employees. To learn more about E-Verify, including your rights and responsibilities, please click the following link to view Federal and E-Verify posters: https://www.e-verify.gov/employees

Pay: $77,700.00 - $124,400.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Disability insurance
• Employee assistance program
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Professional development assistance
• Referral program
• Tuition reimbursement
• Vision insurance

Application Question(s):

• You can demonstrate at least 3 years experience in medical device design assurance and/or product development?
• We have an on-site work environment 5 days a week. You are comfortable commuting to our St. Paul office?

Work Location: In person