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Job Title: Senior Product Safety Engineer (Electrical)

Location: Kalamazoo, MI

Job Type: Full-Time

Position Summar

yWe are seeking an experienced Senior Product Safety Engineer (Electrical) to provide technical leadership in the development, assessment, and regulatory compliance of advanced electrically powered medical device systems. This role is responsible for ensuring product safety throughout the entire product lifecycle—from concept development through commercialization and sustaining engineering

.The ideal candidate will have deep expertise in electrical product safety, system-level risk management, international safety standards, and compliance testing. This individual will collaborate with cross-functional engineering teams to ensure products meet global regulatory and safety requirements while driving technical excellence across complex MedTech programs

.Key Responsibilitie

• sLead electrical product safety activities throughout the complete product development lifecycle
• .Develop and execute Product Safety Plans aligned with project goals, regulatory requirements, and international safety standards
• .Evaluate electrical system architectures, power distribution, isolation methods, grounding, protective circuitry, and fault conditions to ensure safe product designs
• .Partner with Electrical, Firmware, Mechanical, Systems, Quality, Regulatory, Verification, Validation, and Manufacturing Engineering teams to integrate product safety requirements into product development
• .Conduct product safety design reviews and recommend design improvements that minimize risk while maintaining product performance and usability
• .Develop product safety verification strategies, compliance documentation, engineering test plans, and certification support documents
• .Provide technical oversight for electrical safety testing, including coordination with internal and external laboratories
• .Support system-level risk management activities by identifying, assessing, mitigating, and documenting hazards in accordance with applicable medical device standards
• .Collaborate with certification agencies and testing laboratories to achieve and maintain global product certifications
• .Investigate product safety issues, perform root cause analysis, and implement corrective actions for design, manufacturing, and field-related concerns
• .Mentor junior engineers and provide technical leadership while promoting best practices in product safety engineering
• .Support technology evaluations, design trade studies, and continuous improvement initiatives focused on product safety

.Required Qualification

• sBachelor's degree in Electrical Engineering, Biomedical Engineering, or a related engineering discipline
• .6+ years of experience in electrical product development, product safety engineering, or medical device engineering
• .Strong knowledge of electrical system design, embedded hardware, power electronics, grounding, insulation, circuit protection, and fault analysis
• .Experience interpreting and applying international electrical safety standards during product development
• .Experience preparing product safety documentation, compliance strategies, engineering verification plans, and test protocols
• .Excellent analytical, problem-solving, and communication skills
• .Ability to work effectively within cross-functional teams in a highly regulated engineering environment

.Preferred Qualification

• sExperience supporting electrically powered medical devices, electromechanical systems, or regulated healthcare technologies
• .Working knowledge of the following standards
• :IEC 60601-
• 1IEC 60601-1-
• 2IEC 6230
• 4IEC 6236
• 6ISO 1497
• 1IEC 61010 (where applicable
• )Experience working with Nationally Recognized Testing Laboratories (NRTLs), CB Scheme certification, and global product certification organizations
• .Familiarity with
• :Electromagnetic Compatibility (EMC
• )Electrical Safety Testin
• gLeakage Current Testin
• gDielectric Withstand Testin
• gCreepage & Clearance Analysi
• sInsulation Coordinatio
• nEnvironmental Testin
• gExperience supporting Design Controls, Design Verification (DV), Design Validation (DVal), Risk Management Files, and Technical Documentation
• .Demonstrated ability to lead complex engineering programs, mentor engineering teams, and influence cross-functional stakeholders

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