Design Assurance Engineer III - Electrophysiology

About The Role

Design Assurance Engineer III supporting new product development and sustaining activities for cardiac mapping and ablation systems within the EP division. This role involves oversight of safety, quality, and compliance of products to deliver the highest quality product to the customer.

Hybrid: employees required to be in the local office three days per week.

• Work cross‑functionally with R&D, project management, manufacturing, regulatory, clinical and marketing to ensure project success.
• Lead or support the determination and implementation of Design Controls based on Risk Management, Customer Needs, and Manufacturing Input.
• Maintain product risk management documentation (e.g., Hazard Analysis & FMEAs).
• Lead or support the development of and coordinate the execution and documentation of Design Validation and Verification activities.
• Apply systematic problem‑solving methodologies to identify, prioritize, communicate, and resolve quality issues.
• Lead and support the execution and investigation of CAPAs, NCEP, complaints, failure mode investigations, and related activities.
• Demonstrate knowledge of validation and statistical techniques to comply with regulatory requirements and internal standards.
• Navigate gray space by applying risk‑based criteria to prioritize project work.
• Support the cross‑functional team throughout the product life cycle, especially regarding design control and risk management deliverables.

• Minimum bachelor’s degree in Materials, Mechanical, Electrical, Chemical, Biotechnology, Electromechanical or related field of study.
• Minimum 4 years of experience in Quality Assurance and/or Design Assurance, Sustaining, R&D, Manufacturing or related medical device experience.
• Understanding of ISO 13485, ISO 14971, and Quality System Regulations with a focus on Design Controls and Risk Analysis.
• Experience navigating design, manufacturing and/or supplier variations.

• Strong understanding of NCEP/CAPA processes.
• Previous experience creating and maintaining risk documentation such as FMEAs and HAs.
• Experience working with Stature or FMEA MED‑8 software.
• Self‑motivated with a passion for solving problems and a bias for action.
• Ability to manage multiple priorities and work with ambiguity.
• Strong verbal and written communication skills.
• Proficiency in collaborating with interdisciplinary teams.
• Familiarity with EP environment.

Minimum Salary: $81,100. Maximum Salary: $156,000. Compensation includes variable components such as bonuses and long‑term incentives, depending on role and eligibility.

Boston Scientific Corporation is an equal‑opportunity employer. The company takes steps to ensure recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, veteran status, age, mental or physical disability, or any other protected class.