Design Assurance Engineer III - Cardiology

About the Role

The Design Assurance Engineer III directly supports medical device product development from concept through commercialization. The engineer serves as a quality representative on a high‑performing cross‑functional team for product development on a major product category. This high‑visibility position provides excellent growth and development potential.

Hybrid role requiring employees to work from the Arden Hills, MN office at least three days per week.

• Understanding and application of design engineering concepts and tools including DFMEA, Design Verification & Validation, Benchmarking, Test Method Validation, and Design Transfer.
• Apply systematic problem‑solving methodologies to identify, prioritize, communicate, and resolve quality issues.
• Serve as an effective quality leader or team member on a cross‑functional product development team.
• Own and drive deliverables related to Design Controls, Product Performance, Quality, and Compliance.
• Develop and implement quality strategies; seek innovative approaches to attain quality goals.
• Review and approve quality records, including product specifications, design verification test protocols, and design verification test reports.
• Maintain and enhance cross‑functional team relationships.
• Directly interface with internal and external audit activities.

• Bachelor’s degree in engineering (or related technical discipline).
• Minimum 3 years of experience in design assurance, post‑market quality, or R&D engineering.
• Strong mechanical and electrical aptitude.
• Experience writing specifications, test protocols, and technical reports.
• Demonstrated use of quality tools and methodologies including DFMEA, DOE, brainstorming, root cause analysis, and 5‑why.
• Ability to solve complex engineering problems using analysis, experimentation, and statistics.
• Experience with mechanical and electrical test and measurement equipment.
• Strong communication skills; effectively present complex technical information to audiences ranging from peers to senior leadership.
• Proficient use of Microsoft Teams, Word, PowerPoint, and Excel.

• Experience in design engineering or process development, including test method validation, process validation, and continuation engineering.
• Experience in post‑market quality, including returned product analysis and CAPA.
• Experience with medical standards compliance, ISO 13485, ISO 14971, and FDA Quality System Regulations focused on design controls and optimization.
• Experience with Class III Medical Devices, including Electrical Medical Equipment (EME) or Active Implantable Medical Devices (AIMD).
• Adaptable collaborator in a team environment or in self‑directed work.

Boston Scientific Corporation is an equal opportunity employer. Recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.