Sr. Quality Engineer

Additional Locations: 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.

About the role

Boston Scientific is seeking an experienced and highly motivated Senior 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 Senior 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.

Continuous Improvement

• Identify opportunities to improve trending and complaint investigation processes.
• Support implementation of automation, digital tools, and data-driven solutions within EP CIS.
• Lead improvement projects focused on investigation quality, cycle time reduction, and organizational effectiveness.
• Champion a culture of continuous improvement and operational excellence.

Quality & Compliance

• Maintain a strong commitment to patient safety and product quality.
• Ensure compliance with applicable Quality System Regulations, internal procedures, and global requirements.
• Support internal audits, inspections, and regulatory inquiries as required.
• Promote adherence to Boston Scientific quality policies and values.

Required qualifications:

• Bachelor'sDegree in Engineering, Science, or related technical discipline
• 6+ years of relevantwork experience of relevant engineering, quality, product performance, complaint investigation, or post-market experience
• Proven technical leadership and project management skills in product sustainment, post market support and/or manufacturing
• Demonstrates critical thinking and problem-solving capabilities
• Excellent data analysis, written and verbal communication skills
• Proven ability to collaborate and influence across leadership and cross-functional teams

• Experience presenting technical information to senior leadership

Preferredqualifications:

• Degree in Mechanical or Biomedical Engineering, Medicine or Medical Science
• Understanding and working knowledge of Medical Device Quality Systems and Regulatory Requirements
• Clinical knowledge of cardiology procedures
• Experience in the medical device industry
• Experience mentoring technical personnel and developing organizational capabilities
• Complaints investigations and experience with Trackwise

Requisition ID: 634200

Boston Scientific transforms lives through innovative medical technologies that improve the health of patients around the world. As a global medical technology leader for more than 45 years, we advance science for life by providing a broad range of high-performance solutions that address unmet patient needs and reduce the cost of healthcare. Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological, neurological and urological diseases and conditions. Learn more at www.bostonscientific.com and follow us on LinkedIn.