Senior Product Safety Engineer (Electrical) – Medical Devices

Job Title:
Senior Product Safety Engineer (Electrical) – Medical Devices

Job Summary:

Seeking a Senior Product Safety Engineer with 6+ years of experience in electrical product safety for medical devices. The ideal candidate will lead safety engineering, compliance, risk management, and verification activities throughout the product development lifecycle.

Responsibilities:

• Lead electrical product safety and compliance activities.
• Develop Product Safety Plans and verification strategies.
• Support risk management (ISO 14971) and Design Controls.
• Collaborate with cross-functional engineering teams.
• Conduct safety reviews, testing, and certification activities.
• Support regulatory compliance and product commercialization.

Required Skills:

• Bachelor's in Electrical or Biomedical Engineering.
• 6+ years in Product Safety or Medical Device Engineering.
• Strong knowledge of electrical system design and safety.
• Experience with:
• IEC 60601-1
• IEC 60601-1-2
• ISO 14971
• IEC 62304
• IEC 62366
• Experience with EMC, electrical safety testing, and compliance documentation.

Preferred:

• Medical device or regulated healthcare product experience.
• Experience with NRTL/CB Scheme certifications.
• Strong leadership and communication skills.