Boston Scientific
Senior Design Quality Engineer
Boston Scientific, Saint Paul, Minnesota, United States, 55112
Senior Design Quality Engineer
The Senior Design Quality Engineer will serve on a high-performing, cross-functional product development team to design world-class Ambulatory Cardiac Monitoring Systems (CDx) in the Arden Hills location. You will lead safety risk engineering activities including Hazard Analysis, Fault Tree Analysis, and Design Failure Modes and Effects Analysis (DFMEA). This high visibility position provides excellent growth potential. Your responsibilities will include: Owns, creates, maintains and/or supports safety risk management processes, including Hazard Analysis, Fault Tree Analysis, Risk Management Plan, Risk Management Report, and DFMEA Provides support to Design Quality Engineers on new product development and sustaining engineering projects 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 CDx products Develops and maintains the CDx risk management best practices including benchmarking with industry leaders, BSC product lines and as a member of the BSC Risk Management CoP. Required qualifications: Bachelor's degree in Electrical Engineering, Software Engineering, Systems Engineering, Mechanical Engineering, Biomedical Engineering, Material Science, or related discipline. 3+ years of experience in safety risk engineering, design assurance, post-market quality, or R&D. Experience developing or supporting complex, high-reliability systems in a regulated industry, including medical devices, pharmaceuticals, or aerospace. Demonstrated ability to work with cross functional team to solve complex engineering problems using analysis, experimentation, and statistics 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: Bachelor's degree and 5+ years or Master's degree with 3+ years of experience in safety risk engineering, design assurance, post-market quality, or R&D. Direct experience in risk management processes, including Hazard Analysis, Fault Tree Analysis, Risk Management Plan, Risk Management Report, and DFMEA. Experience developing Class II or III Medical Devices, including Electrical Medical Equipment (EME) or Active Implantable Medical Devices (AIMD) Experience working with Regulatory Affairs in product submissions Strong mechanical, electrical, software, or systems aptitude Experience using quality tools and methodologies for design optimization including DFMEA, Design of Experiments (DOE), Brainstorming, Root Cause Analysis, 5 Whys Good Documentation Practice skills Understanding of regulations applicable to medical device design controls and risk management, including FDA 21 CFR 820, ISO 13485, EN ISO 14971, IEC 62304, MDD, and EU MDR Professional Certifications, including American Society for Quality Certified Quality Engineer Team player with a record of success in a fast-paced, dynamic environment Good communication and analytical skills
The Senior Design Quality Engineer will serve on a high-performing, cross-functional product development team to design world-class Ambulatory Cardiac Monitoring Systems (CDx) in the Arden Hills location. You will lead safety risk engineering activities including Hazard Analysis, Fault Tree Analysis, and Design Failure Modes and Effects Analysis (DFMEA). This high visibility position provides excellent growth potential. Your responsibilities will include: Owns, creates, maintains and/or supports safety risk management processes, including Hazard Analysis, Fault Tree Analysis, Risk Management Plan, Risk Management Report, and DFMEA Provides support to Design Quality Engineers on new product development and sustaining engineering projects 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 CDx products Develops and maintains the CDx risk management best practices including benchmarking with industry leaders, BSC product lines and as a member of the BSC Risk Management CoP. Required qualifications: Bachelor's degree in Electrical Engineering, Software Engineering, Systems Engineering, Mechanical Engineering, Biomedical Engineering, Material Science, or related discipline. 3+ years of experience in safety risk engineering, design assurance, post-market quality, or R&D. Experience developing or supporting complex, high-reliability systems in a regulated industry, including medical devices, pharmaceuticals, or aerospace. Demonstrated ability to work with cross functional team to solve complex engineering problems using analysis, experimentation, and statistics 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: Bachelor's degree and 5+ years or Master's degree with 3+ years of experience in safety risk engineering, design assurance, post-market quality, or R&D. Direct experience in risk management processes, including Hazard Analysis, Fault Tree Analysis, Risk Management Plan, Risk Management Report, and DFMEA. Experience developing Class II or III Medical Devices, including Electrical Medical Equipment (EME) or Active Implantable Medical Devices (AIMD) Experience working with Regulatory Affairs in product submissions Strong mechanical, electrical, software, or systems aptitude Experience using quality tools and methodologies for design optimization including DFMEA, Design of Experiments (DOE), Brainstorming, Root Cause Analysis, 5 Whys Good Documentation Practice skills Understanding of regulations applicable to medical device design controls and risk management, including FDA 21 CFR 820, ISO 13485, EN ISO 14971, IEC 62304, MDD, and EU MDR Professional Certifications, including American Society for Quality Certified Quality Engineer Team player with a record of success in a fast-paced, dynamic environment Good communication and analytical skills