Design Quality Assurance Engineer II - Urology

bostonscientific • Marlborough, MA

1d • $72,800 - $138,300 • Hybrid

About The Position

At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions. About the role: 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.

Nice To Haves

• 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.
• Skillful problem solver, capable of facilitating the problem-solving process and driving to solutions in a timely manner.
• Ability to work in a fast paced, dynamic environment while promoting / fostering cross-functional teamwork.
• Strong communication skills (verbal & written)

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