Principal Quality Engineer at Boston Scientific in Maple Grove, MN

Job description

Additional Location(s): N/A; US-MN-Maple Grove 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. The Principal Quality Engineer provides technical quality engineering expertise across product development, design changes, manufacturing operations and quality systems. This role establishes and maintains quality engineering methodologies, systems and practices that meet Boston Scientific, customer and regulatory requirements. The position collaborates with quality management and cross-functional partners to drive quality initiatives, implement process improvements and support organizational quality goals. The role may also mentor less experienced quality professionals and cross-functional stakeholders on quality processes and procedures. Primary responsibilities include supporting quality systems, design change documentation and risk assessments associated with nonconformances and corrective and preventive actions (CAPAs) for Boston Scientific's hepatic artery infusion pump and accessories. Work model, sponsorship, relocation: This is a hybrid position based at Boston Scientific's Maple Grove/Arbor Lakes location in Minnesota. Employees are expected to work on-site 3-4 days/ work to support collaboration and business needs. 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 advanced quality engineering principles to assigned products, processes and sites, guiding implementation to meet internal and external quality and regulatory requirements. Champion departmental and cross-functional engineering initiatives, providing technical direction, coaching and mentoring to engineering and quality teams. Proactively identify, evaluate and implement best-in-class quality engineering practices, processes and systems. Develop and implement effective process and design control systems to support product development, qualification and ongoing manufacturing. Serve as a quality subject matter expert (SME) in applying ISO 14971 risk management principles across product development, clinical investigations, design changes, commercialization and post-market activities. Lead or independently review risk management plans, hazard analyses, failure mode and effects analyses (FMEAs), benefit-risk assessments, risk management reports and associated documentation. Ensure appropriate identification and documentation of hazards, foreseeable sequences of events, hazardous situations, harms, risk controls and residual risks. Assess the implementation of risk control measures and verify their effectiveness in mitigating identified product risks. Evaluate new information from complaints, CAPAs, nonconformances, clinical investigations and post-market surveillance to determine potential impacts on existing product risks. Lead the implementation and continuous improvement of quality assurance processes, process controls and CAPA systems to meet or exceed internal and external requirements. Support cross-functional quality decisions and initiatives, applying systematic problem-solving methodologies to identify, prioritize, communicate and resolve quality issues. Drive the development and execution of efficient business processes and quality systems that enable timely identification and resol