Design Assurance Engineer II – Medical Devices

About the role

Boston Scientific is seeking a Design Assurance Engineer II to support medical device product development from concept through commercialization. The role focuses on product sustaining activities, complaint reduction, and post‑market projects while ensuring compliance with quality system regulations.

Key responsibilities

• Collaborate with cross‑functional teams to solve complex engineering problems using analysis, experimentation, and statistical methods.
• Apply systematic problem‑solving methodologies such as 5 Whys, Is‑Is Not, and DMAIC to prioritize and resolve quality issues.
• Support design control activities including design change analysis, design inputs/outputs, test methods, design reviews, verification & validation, and labeling.
• Create and maintain safety risk‑management artifacts (Hazard Analysis, Fault Tree Analysis, Task and Use Error Analysis, DFMEA, Risk Management Plan/Report).
• Coordinate complaint reduction, NCEP/CAPA initiatives, and post‑market projects with cross‑functional teams.
• Present product performance data to management, committees, and design teams and contribute to management and complaint review reports.
• Assist with internal and external regulatory audits and develop test‑method validation protocols and reports.

Required profile

• Experience in medical‑device product development and sustaining activities.
• Intermediate knowledge of Design Controls and risk‑management processes.
• Strong analytical and communication skills to lead cross‑functional initiatives.
• Ability to interpret field data and link it to risk‑management outcomes.

Required skills

• Design Controls
• Risk Management (Hazard Analysis, Fault Tree Analysis, DFMEA)
• CAPA and NCEP systems
• Statistical analysis and problem‑solving methodologies (5 Whys, DMAIC)
• Test method validation

What we offer

• Access to latest tools, training, and career development resources.
• Collaborative environment with diverse, high‑performing teams.