Job Title: Senior Product Safety Engineer (Electrical)

Location: Kalamazoo, Michigan

Duration: Long Term

Client : Stryker

Position Summar yG8Way Services is seeking an experienced Senior Product Safety Engineer to provide technical leadership for the development, assessment, and compliance of advanced medical device systems. This role is heavily focused on electrical product safety engineering and will support the design, verification, validation, and regulatory compliance of complex electrically powered medical technologies throughout the product lifecycle. The idóneo candidate is an expert in electrical product safety standards, system-level risk management, and compliance testing who can collaborate across multidisciplinary engineering teams to ensure products meet global safety and regulatory requirements.

This individual will provide technical guidance from early architecture through commercialization, sustaining engineering, and product enhancements while helping clients navigate complex safety challenges within highly regulated MedTech environments

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Key Responsibiliti**

- esLead electrical product safety activities across the full product development lifecycle, from concept through commercialization and sustaining engineerin
- g.Develop and execute Product Safety Plans aligned with project objectives, regulatory requirements, and applicable international safety standard
- s.Evaluate electrical system architectures, power distribution, isolation strategies, protective circuitry, and fault conditions to ensure safe and compliant design
- s.Partner with electrical, firmware, mechanical, systems, quality, regulatory, verification, and manufacturing engineering teams to integrate product safety requirements into product design




- s.Perform product safety design reviews and provide technical recommendations to reduce risk while maintaining product performance and usabilit
- y.Develop product safety verification strategies, test protocols, and compliance documentation supporting internal verification and external certification activitie
- s.Provide technical oversight for electrical safety testing, including coordination of laboratory activities and resolution of compliance issues identified during verificatio
- n.Support system-level risk management activities, ensuring hazards are identified, evaluated, mitigated, and documented in accordance with applicable medical device standard
- s.Collaborate with external certification agencies and test laboratories to achieve product certifications and maintain compliance throughout the product lifecycl
- e.Investigate complex product safety issues, perform root cause analysis, and develop effective corrective actions for field, manufacturing, or design-related concern
- s.Provide technical leadership and mentorship to engineers while promoting best practices in electrical product safety and regulatory complianc
- e.Support technology evaluations, design trade studies, and continuous improvement initiatives that advance future product safety capabilitie

s.Required Qualificatio
- nsBachelor's degree in Electrical Engineering, Biomedical Engineering,



or a related engineering disciplin
- e.6+ years of experience in electrical product development, product safety engineering, or medical device engineerin
- g.Strong understanding of electrical system design, power electronics, embedded hardware, circuit protection, grounding, insulation, and fault analysi
- s.Experience interpreting and applying international electrical safety standards throughout product developmen
- t.Experience developing product safety documentation, compliance strategies, and engineering test plan
- s.Strong analytical, problem-solving, and technical communication skill
- s.Ability to work effectively within cross-functional engineering teams in a regulated product development environmen

t.Preferred Qualificatio
- nsExperience supporting electrically powered medical devices, electromechanical systems, or other regulated healthcare technologie
- s.Working knowledge of applicable medical device standards, includin
- g:o IEC 60601
- -1o IEC 60601-1
- -2o IEC 623
- 04o IEC 623
- 66o ISO 149
- 71o IEC 61010 (where applicabl
- e)Experience working with Nationally Recognized Testing Laboratories (NRTLs), CB Scheme certification, or other global product certification organization
- s.Familiarity with EMC, electrical safety, leakage current testing, dielectric withstand testing, insulation coordination, creepage and clearance analysis, and environmental testin
- g.Experience supporting Design Controls, Design Verification, Design Validation, Risk Management Files, and Technical Documentatio
- n.Demonstrated ability to provide technical leadership on complex engineering programs while mentoring junior engineers and influencing cross-functional team

s.

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