Principal Quality Engineer - Medical Devices & CAPA Leader

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

Job summary

Boston Scientific is seeking a Principal Quality Engineer to provide technical quality engineering expertise across product development, design changes, manufacturing operations and quality systems in a hybrid Maple Grove, MN setting. The role partners with quality management and cross‑functional teams to drive initiatives and CAPA-driven improvements.

The position emphasizes mentoring, implementing best practices in quality systems, risk management per ISO 14971, and collaboration with contract

Qualifications

• Bachelor's degree in engineering, science, health sciences or related field.
• 5+ years in medical device/pharma or similarly regulated industry.
• 5+ years with quality systems and controlled processes.
• Experience coordinating CAPAs and quality investigations.

Responsibilities

• Apply advanced quality engineering to 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 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, 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

Risk management

Cross-functional collaboration

Process improvement

Mentoring

Education

Bachelor's degree in engineering/science/health sciences

Biomedical/mechanical/chemical engineering background

Job description

Boston Scientific is seeking a Principal Quality Engineer to provide technical quality engineering expertise across product development, design changes, manufacturing operations and quality systems in a hybrid Maple Grove, MN setting. The role partners with quality management and cross‑functional teams to drive initiatives and CAPA-driven improvements.

The position emphasizes mentoring, implementing best practices in quality systems, risk management per ISO 14971, and collaboration with contract