Senior System Design Quality Engineer

Boston Scientific; Maple Grove (MN); On-site; USD 90,000 - 110,000; Full time

Job summary

Boston Scientific is seeking a Senior System Design Quality Engineer for its Interventional Cardiology division. This key role requires strong collaboration with cross-functional teams to advance product development and ensure compliance with regulatory standards. The position is based in Maple Grove, MN, and involves hybrid work with onsite presence required at least three days a week.

The ideal candidate will hold a Bachelor’s degree and have a minimum of five years’ experience in design assurance within the medical device or regulated industry, alongside strong communication and problem-solving skills.

Qualifications

• Minimum of 5 years of experience in design assurance or quality.
• Solid understanding of regulatory compliance requirements.
• Experience with Class III medical devices preferred.

Responsibilities

• Responsible for design control and risk management.
• Ensure compliance with international standards.
• Apply clinical knowledge to influence device testing.
• Develop plans for design control and risk management.
• Lead the implementation of product risk management tools.

Skills

Strong verbal and written communication skills

Problem-solving

Quality tools and methodologies

Organizational skills

Education

Bachelor’s degree in engineering or science discipline

Tools

ISO 9001

ISO 13485

ISO 14971

IEC 60601-1

IEC 62304

Job description

Senior System Design Quality Engineer – Interventional Cardiology

Boston Scientific is offering a senior‑level role focused on system design quality engineering for a high‑visibility Imaging Guidance System within the Interventional Cardiology division. The position requires strong collaboration with cross‑functional teams to advance product development and ensure regulatory compliance.

Work Mode

This hybrid role is based at the Arbor Lakes Campus in Maple Grove, MN and requires on‑site presence at least three days per week.

Relocation Assistance

Relocation assistance may be available for this position at this time.

Visa Sponsorship

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

Your Responsibilities Include

• Responsible for design control and risk management of next‑generation medical devices.
• Ensure compliance with international standards such as ISO 9001, ISO 13485, ISO 14971, IEC 60601‑1 and IEC 62304.
• Apply clinical knowledge to influence device testing and design decisions.
• Use systematic problem‑solving methodologies to identify, prioritize, communicate, and resolve quality issues.
• Develop, direct, and execute plans for design control and risk management of complex projects, independently or as part of a team.
• Lead the implementation and development of product risk management tools (e.g., Hazard Analysis, Fault Tree, FMEAs).
• Promote and influence compliance to BSC’s quality, business, safety, and market/legal regulations.
• Provide quality input as a subject‑matter expert or independent reviewer at defined project milestones.
• Keep up to date on all ISO/EN/FDA/MDR and other regulatory requirements and relay this information to the Product Development group.
• Participate in the implementation of product software, including risk management (ISO 14971), hazard analysis, software FMEAs, security risk analysis, and software design V&V.
• Act as an effective leader or team member supporting quality disciplines, decisions, and practices.

What We’re Looking For In You

Required Qualifications

• Bachelor’s degree in engineering or science discipline, or equivalent.
• Minimum of 5 years of experience in design assurance, quality, or related medical device or regulated industry experience.
• Solid understanding and demonstrated use of ISO 9001, ISO 13485, ISO 14971, IEC 60601‑1, IEC 62304, CFRs, and Quality System Regulations.
• Strong verbal and written communication and presentation skills.
• Effective problem solver, capable of facilitating the problem‑solving process and driving issues to closure.
• Excellent organizational and planning skills, results‑oriented.
• Adaptable collaborator in a matrixed and geographically diverse business environment.
• Demonstrated use of quality tools and methodologies.

Preferred Qualifications

• Attention to detail with focus on accuracy and completeness.
• Experience collaborating within a highly matrixed and global team.
• Experience with Class III medical devices.

Equal Opportunity Employer Statement

Boston Scientific Corporation has been and will continue to be an equal opportunity employer. All employment 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.