About this Role

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.

Your responsibilities

• 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) 

Preferred Qualifications:

• 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