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Boston Scientific · 1 month ago

Senior Quality Engineer - Capital Equipment Service

Arden Hills, MN

Full-time

Hybrid

Senior Level

6+ years exp

Boston Scientific is a leader in medical science committed to solving critical health challenges. The Senior Service Quality Engineer will lead initiatives to develop and improve service quality for Medical Electrical Equipment, ensuring compliance with global regulatory requirements and enhancing customer outcomes.

Health CareMedicalMedical Device

No H1B

Responsibilities

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

Qualification

Medical Device experienceService Quality SystemRisk ManagementQuality Standards knowledgeSix-Sigma Green BeltSAP systemsContinuous improvementTechnical mentorshipCollaboration