Design Assurance Engineer
Scanlan International, Inc., Minneapolis, MN, United States
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 Design Assurance Engineer to join our organization and continue this commitment.
What You'll Do
The Design Assurance Engineer 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.
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 $72,100 - $115,300, 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.
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)
Training and Development Program
Tuition Assistance Program
Paid Time Off, including:
Holidays
Floating Holidays
Vacation
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
#J-18808-Ljbffr
What You'll Do
The Design Assurance Engineer 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.
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 $72,100 - $115,300, 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.
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)
Training and Development Program
Tuition Assistance Program
Paid Time Off, including:
Holidays
Floating Holidays
Vacation
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
#J-18808-Ljbffr