Senior Design Assurance Engineer - Electrophysiology

Boston Scientific is seeking a Senior Design Assurance Engineer - Electrophysiology to join their team. The successful candidate will be responsible for ensuring design control rigor, robust risk management, and objective evidence supporting safe and effective products from concept through commercialization. The role requires a bachelor's degree in engineering or a related field, 5+ years of experience in design assurance or quality assurance, and working knowledge of ISO 13485 and ISO 14971.

Requirements

• Bachelor’s degree in Engineering or related technical discipline
• 5+ years of experience in Design Assurance, Quality Assurance, R&D, Manufacturing Engineering, or related work in medical devices or other regulated industries
• Working knowledge and demonstrated application of design controls and risk management best practices
• Working knowledge of ISO 13485, ISO 14971, and applicable Quality System Regulations (FDA QSR or equivalent)
• Proven ability to operate effectively in cross-functional teams and communicate clearly in written and verbal formats

Benefits

• Relocation assistance
• Variable compensation governed by the Sales Incentive Compensation Plan
• Core and optional benefits offered at BSC (reviewable at www.bscbenefitsconnect.com)