Senior Quality Engineer - Capital Equipment Service

Senior Quality Engineer - Capital Equipment Service

Onsite Location(s):
Arden Hills, MN, US, 55112

Additional Location(s): N/A

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 Senior Service Quality Engineer is a subject‑matter expert in service quality for Boston Scientific’s Medical Electrical Equipment/ Capital Equipment (CE) products. This position provides leadership in developing, executing, and continuously improving product related service quality requirements, ensuring that service and installation processes meet global regulatory requirements and deliver exceptional customer outcomes. The role bridges product design and field service, ensuring that service performance and feedback directly inform product improvement, risk management, and reliability engineering.

The Service Quality Engineer operates with minimal supervision, leads cross‑functional initiatives, mentors peers, and influences the strategic direction of service quality within the organization.

At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our local office at least three days per week.

Relocation assistance is not available for this position at this time.

Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.

• Lead integration of service requirements into new‑product design and risk‑management processes.
• Serve as the service‑quality owner for assigned products, ensuring alignment between DHF, DMR, and field‑service documentation.
• Evaluate complex product or process changes for quality and risk impact; ensure all risk controls remain effective.
• Champion continuous improvement of product reliability through analysis of field performance data, and service metrics.
• Establish robust systems to ensure accurate Service History Record capture and traceability via Service Management and SAP systems.
• Represent service quality in design reviews, risk assessments, and post‑market monitoring.

• Drive enhancement and standardization of CE‑related Service Quality System elements:
  Design Controls, Risk Management, CAPA/NCEP, Installation & Servicing Controls.
• Lead significant CAPA/NCEP investigations, ensuring strong root‑cause analysis and sustainable corrective actions.
• Partner with global and regional teams to implement best practices for service quality metrics and reliability measurement.
• Lead Service quality‑system integration for acquisitions, assessing gaps, developing integration plans, and mentoring local quality teams.
• Monitor key process indicators for CE service performance, influencing operational and business decisions.
• Collaborate with upstream engineering to implement systemic improvements that reduce service‑related nonconformances.

• Serve as a role model of BSC’s quality and compliance culture.
• Provide mentorship and technical guidance to junior team members and cross‑functional partners.
• Influence leadership teams by presenting balanced risk‑based rationales that protect patients while enabling business agility.
• Foster collaboration across Service Development Engineering, Service QA, NPE Project Management, Field Service, and Global teams.
• Promote a culture of curiosity, accountability, and high performance.
• Lead VIPs and continuous‑improvement initiatives that drive measurable efficiency gains.
• Encourage a “Yes – and here’s how” mindset to support business enablement while maintaining compliance.

• Bachelor’s degree in a technical field
• Minimum of 6 years of related work experience including relevant experience in the Medical Device industry
• Working knowledge of relevant…