Senior Design Assurance Engineer CRM

Additional Location(s): 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: Boston Scientific was recognized by Forbes as one of the Best Workplaces for Engineers in 2026, reflecting a culture where engineers do meaningful work. Boston Scientific was recognized as a Glassdoor Best Place to Work in 2026, ranking No. 15 on the Top 100 list, reflecting the culture our employees experience every day. The Senior Design Assurance Engineer will directly support medical device product development from concept through commercialization and sustainment within the Cardiac Rhythm Management and Diagnostics (CRMDx) division. This role will support the Design Quality Assurance team in a variety of quality-related activities on high-visibility issues and projects impacting active implantable and accessory devices, as well as combination products with a drug component and overall product performance. This individual will collaborate and partner with Research and Development, Regulatory, Marketing, Medical Safety, Manufacturing, Post-Market, Acquisitions and Integrations, and other Quality organizations to achieve optimal results. The role is based in Arden Hills, Minnesota. Work model, sponsorship, relocation: This position is an on-site role based in Arden Hills, Minnesota. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time. Relocation assistance is not available for this position at this time. Your responsibilities will include: * Apply sound, systematic problem-solving methodologies to identify, prioritize, communicate and resolve quality issues. * Act as an effective team member and mentor in supporting quality disciplines, decisions and practices. * Support Design Assurance acquisition integration activities related to risk management remediation, Design Control Quality System integration and other Design Assurance integration priorities. * Support verification, validation and usability testing activities to meet or exceed internal and external requirements. * Develop, update and maintain Design History File and Design Input/Output documentation, including product specifications, component specifications and prints. * Generate, update and maintain product risk management tools, including hazard analyses and FMEAs. * Partner with Research and Development to determine and implement design controls based on risk management, customer needs and manufacturing input. * Create, maintain and enhance cross-functional team partnerships. Provide guidance regarding technical strategies and approaches while working across functions and multiple sites to identify and resolve technical issues. * Perform additional duties as required. Required qualifications: * Minimum Bachelor’s degree with a minimum of 5 years' experience, or Master’s degree with a minimum of 3 years' experience, in design assurance, new product development or related medical device experience. Degree must be in an engineering discipline or related field of study. * Understanding of ISO 13485, ISO 14971 and Quality System Regulations, with a focus on design controls and risk management. * Demonstrated experience using quality tools and methodologies. * Hands-on experience and approach to product development. * Willingness to travel up to 10%. Preferred qualifications: * Proven experience supporting quality integration activities. * Boston Scientific experience preferred * Proven Risk management and ISO 14971...