Design Assurance Engineer II

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Diversity - Innovation - Caring - Global Collaboration - Winning Spirit
- High Performance

At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.

Are you passionate about product quality, patient safety, and building innovative medical technologies that truly matter? We’re looking for a Design Assurance Engineer II to play a key role on a high‑performing, cross‑functional team developing and sustaining high‑risk percutaneous coronary intervention (HRPCI) systems.

In this role, you’ll contribute to cutting‑edge solutions that combine single‑use devices, capital equipment, firmware, and software within our Interventional Cardiology and Vascular Therapies (ICVT) division. You’ll support a high‑visibility product development program, gaining hands‑on experience across the full product lifecycle—from early concept through commercialization—while building a strong foundation for long‑term career growth.

You’ll be a trusted quality partner to R&D, Manufacturing, Regulatory, and Clinical teams, applying design controls and risk management principles to ensure our products are safe, effective, and compliant—while always keeping the patient at the center of what we do.

This role follows a hybrid work model requiring employees to be in our Arbors Lakes, MN office 3 days per week.

Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.

This role will not provide relocation support or assistance.

• Drive and document Design Verification, Validation, and Usability activities that ensure products perform as intended in real‑world use.
• Apply structured, data‑driven problem‑solving methodologies to identify, communicate, and resolve quality issues.
• Partner with cross‑functional teams to embed effective design controls and support development from concept through commercialization.
• Develop, update, and maintain Design History Files (DHF), including Design Inputs, Outputs, and product specifications.
• Lead and maintain risk management artifacts such as Hazard Analyses, Fault Trees, and FMEAs.
• Lead or support root‑cause investigations and corrective actions with cross‑functional stakeholders.
• Evaluate, develop, and validate test and inspection methods to ensure robust design performance.
• Champion patient safety and product quality by ensuring compliance with quality systems, procedures, and regulatory requirements.
• Support regulatory submissions and interactions with notified bodies.

• Minimum of a Bachelor’s degree in Engineering or a related technical discipline
• Minimum of 2 years of experience in Design Assurance, Quality, R&D, or New Product Development within medical devices or another regulated industry
• Strong analytical and problem‑solving skills, with the ability to guide teams through structured investigations
• Ability to work effectively in a matrixed, geographically diverse organization
• Hands‑on experience using quality tools and methodologies

• Working knowledge of FDA regulations, GMP, and ISO 13485
• Advanced computer skills, including statistical analysis, data interpretation, and technical reporting
• Project leadership experience, with the ability to influence cross‑functional teams and drive timely, high‑quality outcomes
• Effective collaborator who thrives in both team‑based and self‑directed environments
• Clear, confident communicator (written and verbal)

Requisition

Minimum Salary: $71500

Maximum Salary: $135800

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see — will vary based on actual location of the position and other pertinent factors considered in determining…