Design Quality Assurance Engineer II - Urology

Design Quality Assurance Engineer II - Urology

Boston Scientific – Maple Grove, MN (Hybrid – on site at least three days per week)

Boston Scientific is a worldwide leader in kidney stone management. The Urology divisional team is dedicated to providing urologists with high‑quality, functional, and flexible visualization products. As a Design Quality Assurance Engineer II, you will collaborate with cross‑functional teams to sustain commercialized Visualization products, including medical electrical systems (MES). You will serve as a Quality representative, ensuring safety, quality, and compliance, and continuously improving product value.

This hybrid role is based in Maple Grove, MN and requires being on site at least three days per week.

Relocation assistance is available for this position at this time.

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

• Act as an effective cross‑functional team member in supporting quality disciplines, decisions, and practices.
• Work with and influence cross‑functional teams during the Design Change process to ensure proposed changes are systematically and thoroughly analyzed, assessed, controlled, and implemented appropriately (e.g., EN 13485 / CFR 820).
• Support planning, updating, and maintenance of product Risk Management documentation (Hazard Analysis, Design FMEA, Task Analysis, and Fault Tree Analysis) in compliance with company procedures and external standards (e.g., EN 14971).
• Support Usability Engineering planning documentation (e.g., EN/ISO 62366 and IEC 60601‑1‑6).
• Interface with the core team and support manufacturing operation efforts / changes to ensure they meet or exceed internal and external requirements.
• Apply systematic problem‑solving methodologies (e.g., 5 Whys, DMAIC) to identify, prioritize, communicate, and resolve quality issues in a timely manner.
• Support post‑market activities to ensure products meet patient, customer, product performance, and quality system expectations through risk‑based assessment of post‑market signals.
• Support internal and external regulatory audits as required.

• Minimum of a Bachelor’s Degree in mechanical, electrical, or biomedical engineering (or another related technical discipline).
• Minimum of 2 years of related experience.

• Experience in the Medical Device industry (quality and risk management) and medical electrical systems.
• Detailed understanding of ISO 13485, ISO 14971, and Quality System Regulations.
• Strong problem‑solving skills with the ability to facilitate the process and drive timely solutions.
• Ability to work in a fast‑paced, dynamic environment while promoting cross‑functional teamwork.
• Strong verbal & written communication skills.

Minimum Salary: $72,800

Maximum Salary: $138,300

Boston Scientific Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered 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.