Product Safety Engineer

Evaluate product designs to uncover safety concerns and potential hazards Apply advanced risk assessment tools, including FMEA and FTA Perform comprehensive reviews to ensure product safety is thoroughly addressed Identify and document risks affecting reliability and compliance Use systematic methodologies to analyze and mitigate potential safety issues in hospital patient monitoring products Ensure safety and compliance documentation is thorough, accurate, and aligned with regulatory standards and internal policies Work independently and influence cross-functional stakeholders Requirements 2+ years of experience with a Bachelor’s OR some experience with a Master’s in DFMEA’s, product quality, and risk management analysis and documentation activities in the medical device industry 5+ years strongly preferred Strong knowledge of relevant regulations and standards, including ISO 13485, ISO 14971, IEC 62304, and IEC 82304 Strong knowledge of FMEAs and risk management-related activities Knowledge of Design for Quality (DFQ) Knowledge of root cause analysis methods Ability to perform minimum Physical, Cognitive and Environmental job requirements with or without accommodation Excellent communication skills and ability to influence cross-functional stakeholders using technical expertise and risk management best practices US work authorization required; candidates requiring sponsorship are not considered Must reside in or within commuting distance to Cambridge, MA; Murrysville, PA; or Orlando, FL Core Competencies Demonstrates expertise in risk management analysis and documentation within the medical device industry, with a strong focus on safety compliance and regulatory standards. Proficient in applying advanced risk assessment tools and methodologies to ensure product reliability and safety. Highest-signal resume keywords Risk Management Analysis FMEA ISO 13485 IEC 62304 Design For Quality Hard Skills Risk Assessment FMEA Root Cause Analysis Product Quality Evaluation Safety Compliance Documentation Soft Skills Excellent Communication Influencing Stakeholders Industry Keywords Medical Device Industry ISO 14971 IEC 82304 Regulatory Standards Systematic Methodologies #J-18808-Ljbffr