Tekhawks

Title: Product Safety Engineer

Location: Kalamazoo, MI (Onsite)
Duration: 12+ months

Position Overview

We are seeking a Senior Product Safety Engineer to lead electrical product safety and regulatory compliance activities for advanced medical devices. This role is responsible for ensuring products meet global safety standards throughout the entire product lifecycle—from concept and design through verification, validation, commercialization, and sustaining engineering. The ideal candidate has strong experience with electrical safety, risk management, compliance testing, and medical device regulations while providing technical leadership across cross-functional engineering teams.

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 development.
• Strong knowledge of electrical system design, power electronics, embedded hardware, grounding, insulation, and fault analysis.
• Experience supporting medical device development in a regulated environment.
• Experience developing product safety documentation, compliance strategies, and engineering test plans.
• Working knowledge of IEC 60601-1, IEC 60601-1-2, ISO 14971, IEC 62304, and IEC 62366.
• Experience with Design Controls, Risk Management, Design Verification (DV), and Design Validation (PV).
• Strong analytical, troubleshooting, and communication skills.
• Ability to lead cross-functional engineering efforts and mentor junior engineers.

Good to Have

• Experience with electrically powered medical devices or electromechanical systems.
• Experience working with NRTLs, CB Scheme, or global certification agencies.
• Knowledge of EMC, leakage current testing, dielectric withstand testing, creepage and clearance analysis, and environmental testing.
• Familiarity with FDA and international medical device regulatory requirements.
• Experience supporting commercialization and sustaining engineering activities.

Skills

• Product Safety Engineering
• Medical Devices
• Electrical Safety
• IEC 60601-1
• IEC 60601-1-2
• ISO 14971
• IEC 62304
• IEC 62366
• Risk Management
• Design Controls
• Design Verification (DV)
• Design Validation (PV)
• Regulatory Compliance
• EMC Testing
• Embedded Hardware
• Power Electronics
• Fault Analysis
• Root Cause Analysis
• Technical Leadership
• Cross-Functional Collaboration