Design Quality Engineer III

About the role

Boston Scientific is recruiting for a Design Quality Engineer III in the Maple Grove, MN location. This role participates in the quality assurance of single‑use devices for use with medical electrical equipment/systems (MEE) within Interventional Cardiology (IC), a rapidly growing division of BSC.

The Design Quality Engineer III will support the application of design controls to projects focusing on design changes, material continuity, regulatory and standards compliance, corrective and preventive actions, and improvements for manufacturability and cost reduction. The engineer will work with a high‑performance cross‑functional team to ensure safety, quality, and compliance of products.

At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our local Maple Grove office three days per week.

Relocation assistance is available for this position.

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

• Ownership of design change projects, including scoping, assessment, and implementation.
• Develop, update, and maintain Design History File and Design Input / Output documentation.
• Develop, update, and maintain risk management files, such as 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 includes 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, from peers to senior leadership.

• Bachelor’s degree in mechanical, electrical, or biomedical engineering.
• 5+ years of experience in design assurance, quality, or related medical device or regulated industry experience.
• Experience with post‑market quality, including returned product analysis and corrective and preventive action (CAPA).
• 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, process validation, and sustaining engineering.
• Adaptable and effective collaborator in a team environment and in self‑directed work.

Requisition

Minimum Salary: $76,000

Maximum Salary: $144,400

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 actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs.

At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.

Compensation for non‑exempt (hourly), non‑sales roles may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other…