Principal Design Quality Engineer - Cardiac Rhythm Management & Diagnostics (CRMDx)

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: This Principal Design Quality Engineer position will support active implantable medical devices.  This position collaborates with cross functional teams including R&D, process development, manufacturing, and regulatory affairs to help ensure that the product and processes remain safe, of high quality, and compliant with BSC and regulatory   requirements throughout the product lifecycle process. Work Mode: Boston Scientific values collaboration, and this hybrid role requires employees to work from the Arden Hills, MN office at least  three  days per week. Relocation Assistance: Relocation assistance is not available for this position. Visa Sponsorship: Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position. Your responsibilities will include:

Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.  Acts as an effective team member in supporting quality disciplines, decisions, and practices. Work within a cross-functional team to identify and implement effective controls for new technology in complex medical devices. Write various technical documentation for procedure execution, technical rationale, and evidence of the development process.  Support Design Assurance activities as related to Risk Management, Design Controls, and other DA related priorities. Support Post Market activities, as necessary, of risk based on post-market signals. Actively participate in the Design Change process to ensure the proposed changes to the products are systemically and thoroughly analyzed and assessed. Demonstrate good working knowledge and application of validation and statistical techniques in compliance with associated regulatory   requirements and internal standards.  Support the verification, validation, and usability testing to meet or exceed internal and external   requirements. Develop, update, and maintain Design History File and Design Input / Output documentation (Product Specification, Component Specifications, and Prints). Generate, update, and maintain product risk management tools (e.g., Hazard Analysis, Fault Tree, FMEAs). Partner with R&D to determine and implement Design Controls based on Risk Management, Customer Needs, and Manufacturing Input.  Partner cross-functionally to identify and support value improvement efforts to support business goals.

Minimum of a bachelor’s degree in mechanical, electrical, or biomedical engineering (or other related technical discipline). 9+ years   of experience in design assurance, new product development or related medical device / regulated industry experience. Self-motivated with a passion for solving problems and a bias for action. Strong communication skills (verbal & written). Demonstrated use of Quality tools/methodologies. Ability to effectively work and collaborate in a mixed onsite + remote environment. Demonstrated experience creating detailed technical documents.

Experience working with medical electrical equipment and/or active implantables. ISO 13485, ISO 14971 and Quality System Regulations understanding with a focus on Design Controls and Risk Analysis. Experienced problem solver, capable of facilitating the problem-solving process.