Principal Quality Engineer
Boston Scientific
- Location
- Zona Franca La Lima, Cartago, CR
- Work model
- On-Site
- Level
- Principal
- H-1B history
- 46 approvals (FY2023)
About this role
Additional Locations: Cartago 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. About the role Boston Scientific is seeking an experienced and highly motivated Principal Quality Engineer to join the Electrophysiology Complaint Investigation Site (EP CIS) organization in Cartago, Costa Rica. This role will serve as a technical leader within the Post-Market Quality Assurance organization, providing expertise in complaint investigations, product performance assessment, signal detection, root cause analysis, and continuous improvement activities across the EP portfolio. The Principal Engineer will act as a key subject matter expert, partnering with global cross-functional teams to evaluate complex product performance issues, drive technical investigations, strengthen organizational capabilities, and support the continued expansion of EP CIS operations in Costa Rica. This position offers significant visibility across divisional leadership, Research & Development, Regulatory Affairs, Manufacturing, Clinical, and Quality organizations. The role aligns with the strategic growth and capability expansion plans for EP CIS and Cartago-based investigation activities. Key Responsibilities Technical Leadership · Serve as a technical expert for complex complaint investigations involving Electrophysiology products manufactured at the Cartago site. · Lead investigations requiring advanced engineering analysis, manufacturing knowledge, clinical understanding, and cross-functional collaboration. · Guide technical assessment of emerging product performance signals and trends. · Support development of robust root cause hypotheses and investigation strategies. · Drive adoption of advanced analytical approaches to improve investigation effectiveness and consistency. · Provide technical direction for challenging or high-visibility quality issues. Product Performance & Risk Management · Analyze complaint, adverse event, and product performance data to identify actionable trends and emerging risks. · Support escalation and resolution of significant product performance concerns. · Lead or support activities associated with NCEPs, CAPAs, health hazard evaluations, and other quality system processes. · Partner with Risk Management teams to evaluate the impact of post-market findings on product risk profiles. · Support development and presentation of product performance insights to leadership teams. Organizational Capability Development · Mentor engineers, investigators, and technical personnel across the CIS organization. · Contribute to development of technical training materials and competency-building programs. · Support strategic initiatives designed to expand CIS capabilities within Cartago. · Serve as a technical resource for onboarding and development of new team members. · Help establish Cartago as a center of excellence for an interconnected post-market quality system. Cross-Functional Collaboration · Partner closely with R&D, Manufacturing, Clinical, Regulatory, Medical Safety, and Product Quality teams. · Influence technical decision-making through data-driven recommendations. · Support design and process engineering teams with post-market insights to drive continuous product improvement. · Participate in cross-site initiatives supporting global EP quality objectives with occasional short-term travel within or outside of Costa Rica · Collaborate with global counterparts to standardize best practices and technical approaches.