The Principal Quality Engineer will serve on a high-performing, cross-functional product development team to design and sustain world class Cardiac Rhythm Management (CRM) Systems. You will lead the safety risk engineering activity including Hazard Analysis, Fault Tree Analysis, and Design Failure Modes and Effects Analysis (DFMEA). This high visibility position provides excellent growth potential.
Owns, creates, maintains and/or supports safety risk management processes, including Hazard Analysis, Fault Tree Analysis, Risk Management Plan, Risk Management Report, and DFMEA
Highly cross-functional in nature, this role consults with product experts, R&D, post market quality, and medical safety functions for risk analysis across the life of Boston Scientific CRM products
May provide support to Design Quality Engineers on new product development and sustaining engineering projects
What we’re looking for in you Minimum Qualifications:
BS degree in Electrical Engineering, Software Engineering, Systems Engineering, Mechanical Engineering, Biomedical Engineering, Material Science, or related discipline
9+ years of experience in safety risk engineering, design assurance, post-market quality, or R&D
Experience developing and/or supporting complex, high-reliability systems in a regulated industry, including medical devices, pharmaceuticals, or aerospace.
Team player with a record of success in a fast-paced, dynamic environment
Demonstrated ability to solve complex engineering problems using analysis, experimentation, and statistics
Good communication and analytical skills
Familiarity with risk management processes, including Hazard Analysis, Fault Tree Analysis, Risk Management Plan, Risk Management Report, DFMEA, and Corrective and Preventive Actions (CAPA)
Direct experience in risk management processes, including Hazard Analysis, Fault Tree Analysis, Risk Management Plan, Risk Management Report, and DFMEA
Experience developing Class III Medical Devices, including Electrical Medical Equipment (EME) or Active Implantable Medical Devices (AIMD)
Strong mechanical, electrical, software, or systems aptitude
Experience using quality tools and methodologies for design optimization including DFMEA, Design of Experiments (DOE), Finite Element Analysis (FEA), Brainstorming, Root Cause Analysis, Ishikawa diagram, 5 Why’s
Understanding of regulations applicable to medical device design controls and risk management, including FDA 21 CFR 820, ISO 13485, EN ISO 14971, MDD, AIMD, and EU MDR
Professional Certifications, including American Society for Quality Certified Quality Engineer
Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world.
Our work is guided by core values that define Boston Scientific culture and empower our employees.
A career with Boston Scientific is more than just a job. It’s personal. As a leader in medical science we’re committed to solving the challenges that matter most – united by a deep caring for human life. If you’re a natural problem-solver with the imagination, courage and spirit to make a meaningful difference, there’s no better place to build your career.