Design Quality Engineer III - Interventional Cardiology

Design Quality Engineer III - Interventional Cardiology

Boston Scientific is seeking a Design Quality Engineer III to support the quality assurance of single‑use devices used with medical electrical equipment and systems (MEE) within Interventional Cardiology (IC) at our Maple Grove, MN location. This hybrid role requires presence in the local office at least three days per week.

Relocation assistance is available for this position, and the company does not sponsor or take over employment visas.

Hybrid – employees must work in the Maple Grove, MN office at least three days per week.

• Identify and implement effective controls to support development or maintenance of products to meet internal and external requirements.
• Develop, update, and maintain Design History File and Design Input / Output documentation.
• Develop, update and maintain risk management files, such as the Hazard Analysis, Task Analysis and Design FMEA.
• Develop and execute Design Verification, Design Validation, and Usability protocols and reports to meet or exceed internal and external requirements.
• Provide design quality support in the resolution of PIRs, CAPAs, and NCEPs.
• Apply sound, systematic problem‑solving methodologies in identifying, prioritizing, communicating and resolving quality issues.
• Demonstrate a primary commitment to patient safety and product quality by maintaining compliance with the Quality Policy and all other documented quality processes and procedures.

• Bachelor’s degree in an engineering discipline.
• Minimum of 3 years of experience in design assurance, quality, or related medical device or regulated industry experience.
• Experience writing specifications, test protocols, and technical reports.
• Demonstrated use of quality tools and methodologies including DFMEA, Hazard Analysis, Root Cause Analysis.
• Demonstrated ability to solve complex engineering problems using analysis, experimentation, and statistics.
• Strong communication skills (verbal and written). Effectively present complicated technical information to small and large audiences.

• Bachelor’s degree in mechanical, electrical, or biomedical engineering.
• Experience with medical device standards compliance, including ISO 13485, ISO 14971 and FDA Quality System Regulations with a focus on design controls and design optimization.
• Experience in design engineering or process development, including design optimization and process validation.
• Adaptable and effective collaborator in a team environment and in self‑directed work.

Requisition

Minimum Salary: $76,000

Maximum Salary: $144,400

Compensation will be commensurate with experience, education, licensure, and certifications, and may include variable components such as bonuses and incentives.

Boston Scientific Corporation is an equal‑opportunity employer. All hiring decisions are made without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, veteran status, age, disability, genetic information or other protected class. We comply with applicable federal, state, and local laws concerning equal employment opportunity.

Some positions, including this one, may require proof of COVID‑19 vaccination status or a prohibited substance test as a safety‑sensitive requirement.

Not Applicable

Full‑time

Other

Medical Equipment Manufacturing