Design Quality Assurance Engineer II - Urology

Boston Scientific • Osseo, MN

3d • Hybrid

About The Position

Boston Scientific is a worldwide and diverse company who puts patients first. As an industry leader in kidney stone management, the Urology divisional team is on a mission to provide urologists with products that offer the best quality, functionality, and flexibility he/she/they need to treat their patients. As a Design Quality Assurance Engineer II, you'll be at the heart of that mission by working with high-performing cross-functional teams to primarily sustain commercialized Visualization products, including medical electrical systems (MES). He/she/they will serve as a Quality representative who can directly impact patient care by ensuring the safety, quality, post market performance and compliance of the visualization franchise products are maintained while continuously improving their value. He/she/they will interface with cross-functional teams to complete sustaining projects, design control deliverables, and activities to ensure our products continue to meet state of the art regulatory standards and user needs. Work mode:At Boston Scientific, we value collaboration and synergy. This hybrid role is based in Maple Grove, MN and requires being on-site at least three days per week.

Requirements

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

Responsibilities

• Act as an effective cross-functional team member in supporting quality disciplines, decisions, and practices.
• Effectively works with and influences cross-functional teams during the Design Change process to ensure proposed changes to products are systemically / thoroughly analyzed, assessed, controlled and implemented appropriately (i.e., EN 13485 / CFR820).
• Support planning, updating and maintenance of product Risk Management documentation (Hazard Analysis, Design FMEA, Task Analysis and Fault Tree Analysis, etc.) in compliance with Boston Scientific procedures and external standards (i.e., EN 14971).
• Support Usability Engineering and planning documentation (i.e., EN / ISO 62366 and IEC 606061-1-6).
• Interface with the core team and support manufacturing operation efforts / changes to ensure they meet or exceed internal and external requirements.
• Apply sound, systematic problem-solving methodologies (e.g., 5 Whys analysis, Is-Is Not analysis, DMAIC problem solving methodologies) in identifying, prioritizing, communicating, and resolving quality issues in a timely manner.
• Supporting post market activities ensuring our 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees