Product Safety Engineer

Pentangle Tech Services | P5 Group; Kalamazoo (MI); On-site; USD 110,000 - 160,000; Full time

Job summary

Pentangle Tech Services | P5 Group in Kalamazoo, MI is seeking a Senior Product Safety Engineer (Electrical) to lead electrical safety and regulatory compliance activities for advanced medical device products. You will work with cross-functional engineering teams to ensure products meet global safety standards throughout the product lifecycle—from concept to commercialization and sustaining engineering.

The role emphasizes leadership, hands-on design review, and coordination with Certification

Qualifications

• Bachelor's degree in Electrical Engineering, Biomedical Engineering, or related field.
• 6+ years of experience in Product Safety, Electrical Engineering, or Medical Device Engineering.
• Strong knowledge of electrical system design, power electronics, circuit protection, grounding, insulation, and fault analysis.
• Experience with electrical safety standards and regulatory compliance.
• Strong analytical, problem-solving, and communication skills.
• Experience working in regulated product development environments.

Responsibilities

• Lead electrical product safety engineering for medical device development projects.
• Develop and execute product safety plans and compliance strategies.
• Review electrical system designs, power distribution, grounding, insulation, and protection circuits to ensure safe product architecture.
• Collaborate with Electrical, Mechanical, Firmware, Systems, Quality, Regulatory, and Manufacturing teams.
• Conduct product safety design reviews and support risk management activities.
• Develop verification plans, test protocols, and compliance documentation.
• Coordinate electrical safety testing and work with certification laboratories.
• Investigate product safety issues and drive corrective actions.
• Mentor junior engineers and provide technical leadership on safety compliance.

Skills

Electrical design

Power electronics

Circuit protection

Grounding & insulation

Fault analysis

Regulatory compliance

Analytical thinking

Communication skills

Regulated environments

Education

Bachelor's in Electrical Engineering

Job description

Location: Kalamazoo, Michigan

Experience: 6+ Years

Industry: Medical Devices / MedTech

About the Role

Client is looking for a Senior Product Safety Engineer (Electrical) to lead electrical safety and regulatory compliance activities for advanced medical device products. You will work with cross-functional engineering teams to ensure products meet global safety standards throughout the entire product development lifecycle—from concept to commercialization and sustaining engineering

.

Key Responsibilities

• Lead electrical product safety engineering for medical device development projects


• Develop and execute product safety plans and compliance strategies


• Review electrical system designs, power distribution, grounding, insulation, and protection circuits to ensure safe product architecture


• Collaborate with Electrical, Mechanical, Firmware, Systems, Quality, Regulatory, and Manufacturing teams


• Conduct product safety design reviews and support risk management activities


• Develop verification plans, test protocols, and compliance documentation


• Coordinate electrical safety testing and work with certification laboratories


• Investigate product safety issues and drive corrective actions


• Mentor junior engineers and provide technical leadership on safety compliance

Required Qualifications

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


• 6+ years of experience in Product Safety, Electrical Engineering, or Medical Device Engineering


• Strong knowledge of electrical system design, power electronics, circuit protection, grounding, insulation, and fault analysis


• Experience with electrical safety standards and regulatory compliance


• Strong analytical, problem-solving, and communication skills


• Experience working in regulated product development environments

Preferred Qualifications

• Experience with electrically powered medical devices or healthcare technologies


• Knowledge of standards such as IEC 60601-1, IEC 60601-1-2, IEC 62304, IEC 62366, ISO 14971, and IEC 61010


• Experience with NRTL/CB Scheme certifications and global compliance testing


• Familiarity with EMC testing, leakage current, dielectric withstand testing, creepage & clearance analysis, and Design Controls


• Proven ability to lead cross-functional engineering teams and mentor junior engineers