Senior Design Quality Engineer - Bolt Integration

Additional Location(s): US-MN-Maple Grove; US-MN-Arden Hills 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: The Senior Design Quality Engineer provides support with high visibility which will provide the right candidate with excellent growth potential. Work with high-performance cross-functional sustaining team to ensure safety, quality and compliance of launched products while continuously improving their commercial value through end-of-life. The role would be supporting SEISMIQ console sustainment manufactured at Arden Hills and Carlsbad site. The Senior Design Quality Engineer works in close partnership with Research and Development and supporting functions (supplier engineering, operations, regulatory, post market) focuses on protecting the design intent of a product to meet safety, efficacy, regulatory, and business requirements. May mentor less experienced Quality staff, as well as other cross-functional stakeholders on implementing Quality processes and procedures as appropriate. Work mode: At Boston Scientific, we value collaboration and synergy. This hybrid role is based at the Arbor Lakes Campus in Maple Grove, MN and requires being on-site at least three days per week. We will also consider candidates based in Arden Hills, MN. Relocation assistance: Relocation assistance may be available for this position at this time. Visa sponsorship: Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time. Your responsibilities will include: * Acts as an effective leader or team member in supporting quality disciplines, decisions, and practices. * Applies experienced technical quality engineering principles to assigned products or sites and guides them into implementation. * Provides project direction, coaching, and mentoring for engineering and technical team personnel. * Advise management on potential improvements or enhancement to quality systems and processes in the company. * Provides support and guidance to team members * Proactively investigates, identifies, and implements best-in-class Design Quality Engineering practices. * Actively participate in the Design Change process for systems to ensure the proposed changes to the products are systemically and thoroughly analyzed and assessed through the Design Control process. * Partner with R&D, manufacturing, supplier team and cross-site teams to determine and implement Design Controls based on Risk Management, Customer Needs, and Manufacturing Input. * Applies systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues, which may include NCEP and CAPA ownership, core team member and coordination * Monitor field performance of recently launched and established medical devices against risk assessments * Actively participate on Risk Change assessment process: generate, update, and maintain product risk management tools (i.e. Hazard Analysis, Fault Tree, FMEAs). * Support the verification, validation, and usability testing to meet or exceed internal and external requirements * Interact with software changes for alignment with system level design impact assessments. * Develop, update, and maintain Design History File and work with RD for Design Input / Output documentation (Product Specification, Component Specifications, and Prints) What we’re looking for in you: Required qualifications: * Bachelor’s degree in chemical, medical engineering, science, mechanical, electrical, computer...