Senior Product Safety Engineer (Electrical)

Pentangle Tech Services | P5 Group; Kalamazoo (MI); On-site; USD 110,000 - 140,000; Full time

Job summary

Pentangle Tech Services | P5 Group in Kalamazoo, MI seeks a Senior Electrical Safety Engineer to lead product safety activities across the full development lifecycle.

You will develop safety plans, evaluate electrical architectures, and collaborate with cross-functional teams to ensure compliant designs for medical devices.

Responsibilities include facilitating regulatory certifications, documentation, and risk management aligned with IEC 60601 and related standards.

Qualifications

• Bachelor'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 understanding of electrical system design, power electronics, embedded hardware, circuit protection, grounding, insulation, and fault analysis.
• Experience interpreting and applying international electrical safety standards throughout product development.
• Experience developing product safety documentation, compliance strategies, and engineering test plans.

Responsibilities

• Lead electrical product safety activities across the full product development lifecycle, from concept through commercialization and sustaining engineering.
• Develop and execute Product Safety Plans aligned with project objectives, regulatory requirements, and applicable international safety standards.
• Evaluate electrical system architectures, power distribution, isolation strategies, protective circuitry, and fault conditions to ensure safe and compliant designs.
• Partner with cross-functional engineering teams to integrate product safety requirements into product designs.
• Perform product safety design reviews and provide technical recommendations to reduce risk while maintaining performance.
• Develop product safety verification strategies, test protocols, and compliance documentation for internal verification and external certification.
• Provide technical oversight for electrical safety testing and coordinate laboratory activities.
• Support system-level risk management, ensuring hazards are identified, evaluated, mitigated, and documented per medical device standards.
• Collaborate with external certification agencies and test laboratories to achieve product certifications.
• Investigate complex product safety issues, perform root cause analysis, and develop corrective actions.
• Provide technical leadership and mentorship to engineers while promoting best practices in electrical product safety and regulatory compliance.
• Support technology evaluations and continuous improvement initiatives that advance product safety capabilities.

Skills

Electrical system design

Power electronics

Embedded hardware

Regulatory compliance

Technical communication

Cross-functional collaboration

Education

Bachelor's degree in Electrical Engineering, Biomedical Engineering, or related field

Job description

Key Responsibilities

• Lead electrical product safety activities across the full product development lifecycle, from concept through commercialization and sustaining engineering.
• Develop and execute Product Safety Plans aligned with project objectives, regulatory requirements, and applicable international safety standards.
• Evaluate electrical system architectures, power distribution, isolation strategies, protective circuitry, and fault conditions to ensure safe and compliant designs.
• Partner with electrical, firmware, mechanical, systems, quality, regulatory, verification, and manufacturing engineering teams to integrate product safety requirements into product designs.
• Perform product safety design reviews and provide technical recommendations to reduce risk while maintaining product performance and usability.
• Develop product safety verification strategies, test protocols, and compliance documentation supporting internal verification and external certification activities.
• Provide technical oversight for electrical safety testing, including coordination of laboratory activities and resolution of compliance issues identified during verification.
• Support system-level risk management activities, ensuring hazards are identified, evaluated, mitigated, and documented in accordance with applicable medical device standards.
• Collaborate with external certification agencies and test laboratories to achieve product certifications and maintain compliance throughout the product lifecycle.
• Investigate complex product safety issues, perform root cause analysis, and develop effective corrective actions for field, manufacturing, or design-related concerns.
• Provide technical leadership and mentorship to engineers while promoting best practices in electrical product safety and regulatory compliance.
• Support technology evaluations, design trade studies, and continuous improvement initiatives that advance future product safety capabilities.

Required Qualifications

• Bachelor'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 understanding of electrical system design, power electronics, embedded hardware, circuit protection, grounding, insulation, and fault analysis.
• Experience interpreting and applying international electrical safety standards throughout product development.
• Experience developing product safety documentation, compliance strategies, and engineering test plans.
• Strong analytical, problem-solving, and technical communication skills.
• Ability to work effectively within cross-functional engineering teams in a regulated product development environment.

Preferred Qualifications

• Experience supporting electrically powered medical devices, electromechanical systems, or other regulated healthcare technologies.
• Working knowledge of applicable medical device standards, including:
  • IEC 60601-1
  • IEC 60601-1-2
  • IEC 62304
  • IEC 62366
  • ISO 14971
  • IEC 61010 (where applicable)
• Experience working with Nationally Recognized Testing Laboratories (NRTLs), CB Scheme certification, or other global product certification organizations.
• Familiarity with EMC, electrical safety, leakage current testing, dielectric withstand testing, insulation coordination, creepage and clearance analysis, and environmental testing.
• Experience supporting Design Controls, Design Verification, Design Validation, Risk Management Files, and Technical Documentation.
• Demonstrated ability to provide technical leadership on complex engineering programs while mentoring junior engineers and influencing cross-functional teams.