Principal Quality Engineer

Boston Scientific; Maple Grove (MN); Hybrid; USD 102,000 - 194,000; Full time

Job summary

Boston Scientific Corporation in Minnesota is seeking a Principal Quality Engineer to provide technical quality engineering expertise across product development, design changes, manufacturing operations and quality systems. This hybrid role at Maple Grove/Arbor Lakes involves mentoring teams and driving quality initiatives.

The position requires a Bachelor's degree in engineering or related field and 5+ years in regulated industries, with experience in CAPAs, risk management, and quality

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.

Responsibilities

• Apply advanced quality engineering principles to products, processes and sites, guiding implementation to meet internal and external quality and regulatory requirements.
• Lead 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.

Skills

Quality engineering

CAPA management

Regulatory compliance

Cross-functional collaboration

Education

Bachelor's degree in engineering or related field

Job description

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.

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.

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.

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:637100

Minimum 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.

Boston Scientific transforms lives through innovative medical technologies that improve the health of patients around the world. As a global medical technology leader for more than 45 years, we advance science for life byprovidinga broad range of high-performance solutions that address unmet patient needs and reduce the cost of healthcare. Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological,neurologicaland urological diseases and conditions. Learn more at www.bostonscientific.com and follow us on LinkedIn .

Boston Scientific Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.

Among other requirements, Boston Scientific maintains specificprohibited substancetest requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.

Nearest Major Market: Minneapolis
Job Segment: Quality Engineer, Pharmaceutical, R&D Engineer, Compliance, Medical Device Engineer, Engineering, Science, Legal