Additional Location(s): N/A; US-MN-Maple Grove
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 resolution of quality issues.
- Partner with management to recommend and implement improvements to quality systems, processes and overall operational effectiveness.
Required qualifications:- Bachelor's degree in engineering, science, health sciences or a related field.
- Minimum of 5 years' experience in the medical device, pharmaceutical or a similarly regulated industry.
- Minimum of 5 years' experience working with quality systems and controlled processes.
- Experience coordinating or managing CAPAs and quality investigations, including initiating and managing design changes.
Preferred qualifications:- Bachelor's degree or technical background in biomedical, mechanical or chemical engineering.
- Minimum of 8 years' experience in the medical device industry.
- Experience leading CAPAs and quality investigations, including initiating and managing design changes.
- Experience supporting quality systems, design change documentation and risk assessments associated with nonconformances and CAPAs.
- Strong communication and collaboration skills, with the ability to engage cross-functional partners, including contract manufacturers, suppliers, operations and supplier quality teams.
- Ability to work independently, manage priorities and execute assignments with appropriate direction.
- Previous experience with Boston Scientific's quality systems, processes or products.
Requisition ID: 637100Minimum Salary: $ 102100 Maximum Salary: $ 194000 The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) - see www.bscbenefitsconnect.com-will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs.
At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.Compensation for
non-exempt (hourly), non-sales roles may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).
Compensation for
exempt, non-sales roles may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).
For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.
