Arden Hills, MN30+ days ago
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 successin a fast-paced, dynamic environment Good communication and analytical skills Requisition ID:607580 Minimum Salary:$82600 Maximum Salary: $156900 The anticipated compens tion listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) - see www.bscbenefitsconnect.com--will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. 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.