Senior Quality Engineer – Post‑Market Electrophysiology

About the role

Boston Scientific is seeking a Senior Quality Engineer to lead post‑market quality activities for its Electrophysiology portfolio at the Cartago site in Costa Rica. The role serves as a technical authority on complaint investigations, product performance assessment, and continuous improvement, partnering with global R&D, manufacturing, regulatory, and clinical teams.

Key responsibilities

• Lead complex complaint investigations, applying advanced engineering analysis, manufacturing knowledge, and clinical insight.
• Analyze adverse event and product performance data to identify trends, risks, and actionable insights.
• Develop and drive root‑cause hypotheses, investigation strategies, and CAPA execution.
• Mentor engineers and investigators, creating technical training and competency programs.
• Collaborate with cross‑functional teams to influence design and process improvements based on post‑market findings.
• Identify and implement automation, digital tools, and data‑driven solutions to enhance investigation efficiency.

Required profile

• Bachelor’s degree in Engineering, Science, or a related technical discipline.
• Minimum 6 years of experience in engineering, quality, product performance, or post‑market support within the medical device industry.
• Proven technical leadership and project‑management skills in product sustainment and manufacturing environments.
• Strong critical‑thinking, problem‑solving, and communication abilities.
• Experience presenting technical information to senior leadership and influencing cross‑functional decisions.

Required skills

• Advanced engineering analysis
• Manufacturing knowledge
• Clinical understanding of electrophysiology procedures
• Data analysis and root‑cause analysis
• Risk management and regulatory compliance
• Trackwise complaint management system
• Medical device quality systems (ISO 13485, FDA QSR)