About the role: We have an exciting opportunity for a Design Assurance Engineer II supporting front end EP division. This position supports several product categories with high visibility which will provide the right candidate with excellent growth potential, commercial experience, and perspective in the medical device industry. The DA Engineer will work with a high-performance cross-functional team to ensure safety, quality, and compliance of products to deliver the highest quality product to the customer. Your responsibilities include: Work cross-functionally with R&D, project management, manufacturing, regulatory, clinical and marketing to ensure project success. Able to understand device performance and anatomy interaction and identify opportunities for device and procedure improvements. Leads/supports the determination and implementation of Design Controls based on Risk Management, Customer Needs, and Manufacturing Input. Maintains product risk management documentation (i.e. Hazard Analysis, Fault Tree, FMEAs). Leads/supports the development of and coordinates the execution and documentation of Design Validation and Verification activities. Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues. Supports and leads the execution and investigation of CAPAs, NCEP, Complaints, Failure Mode Investigations, etc. Demonstrate good working knowledge and application of validation and statistical techniques to comply with associated regulatory requirements and internal standards. Able to navigate gray space by applying risk-based criteria to prioritize project work. Support cross functional team through product life cycle process; specifically, with respect to design control and risk management deliverables. Required Qualifications: Minimum of a bachelor's degree in Materials, Mechanical, Electrical, Chemical, Biotechnology, Electromechanical or related field of study. English Level desired: 90% or greater. Minimum 2 years of experience in Quality Assurance and/or Design Assurance, Sustaining or related medical device experience. ISO 13485, ISO 14971, and Quality System Regulations understanding with a focus on Design Controls and Risk Analysis. Experience navigating manufacturing and/or supplier variations Preferred Qualifications: Self-motivated with a passion for solving problems and a bias for action. Ability to manage multiple priorities and work with ambiguity. Strong communication skills (verbal & written). Proficiency in collaborating with interdisciplinary teams. Familiar with EP environment Requisition ID: 580229 As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen. So, choosing a career with Boston Scientific (NYSE: BSX) isn't just business, it's personal. And if you're a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!
