This job is with Boston Scientific, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ business community. Please do not contact the recruiter directly. Additional Location(s): N/A Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance 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 III, you’ll be at the heart of that mission by working with high-performing cross-functional teams to primarily focus on Value Improvement Projects (VIPs) which are intended to continually improve the quality, delivery, and cost of Core Stone products. 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 Urology 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. Your responsibilities include: 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). Work with cross functional team members on Value Improvement Projects (VIPs) which are intended to continually improve the quality, delivery, and cost of BSC products. Support Risk Management planning, updating and maintenance of the product risk documentation (Hazard Analysis, Design FMEA, Task Analysis and Fault Tree Analysis, etc.) in compliance with Boston Scientific procedures and external standards (eg. EN 14971). Support Usability Engineering and planning documentation (eg. EN 62366/ISO 62366) Interface with the core team and support the sustaining effort for both product and packaging designs. 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. 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 we’re looking for in you: Required Qualifications: BS in Engineering (Biomedical, Electrical, Software or equivalent). 3-6 years of related experience. Travel approximately LI-DNI