Principal Service Quality Engineer

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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 Service Quality Engineer provides technical leadership and advanced expertise to ensure Boston Scientific’s capital equipment products meet the highest standards of quality, safety, and reliability. This role serves as a subject matter expert (SME) for service quality engineering within the laser portfolio, influencing service processes, product design for serviceability, and supporting field reliability improvements.

• Provide technical leadership and oversight for service quality throughout the product lifecycle — from design and development through post-market support.
• Partner with Service Development Engineering to ensure serviceability, maintainability, and reliability are incorporated into product design requirements.
• Lead development and review of Service Risk Analyses, Service Plans, installation/maintenance validation activities, and field service documentation.
• Ensure service controls and field procedures are compliant with global regulatory requirements (e.g., 21 CFR 820.170, ISO 13485, ISO 14971).
• Represent Service Quality in cross-functional reviews, risk assessments, and change control activities impacting field service or customer use.
• Drive root cause analysis and CAPA activities related to service issues, ensuring effective and timely closure.
• Collaborate with divisional Quality and Post-Market Surveillance teams to ensure service-related data feeds into product reliability models and quality planning. Support trend analysis of field performance data to identify systemic issues, product reliability risks, and improvement opportunities.
• Participate in internal and external audits as a Service Quality SME; provide audit readiness support to divisional teams.
• Support process maturity initiatives by developing and refining tools, templates, and metrics used across the Service Quality function.
• Build strong partnerships with R&D, Manufacturing, and Field Service organizations to influence design and serviceability outcomes.
• Provide mentorship and technical guidance to Service Quality Engineers across Service Quality team.
• Partner with Service Development Engineering leadership and Quality Management to ensure consistent support and prioritization of service projects across the portfolio.

• Bachelor’s degree in a technical field.
• 7+ years of relevant experience in Quality – Design, Operations, or Service
• Excellent written and verbal communication skills, with the ability to work with partners across the company
• Working knowledge of IEC,62353 and 21
  
  CFR
  820 regulations
• Proven success mentoring and influencing across cross-functional, global environments.
• Hands‑on experience with CAPA and structured problem solving
• Ability to travel internationally up to 10%

Requisition :620194

As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate.

Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.

So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem‑solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!

Quality Engineer, CAPA, PLM, Field Service, Manufacturing Engineer, Engineering, Management, Manufacturing