Senior Product Safety Engineer, Medical Devices

CSA Group Testing & Certification Inc.; Irvine (CA); On-site; USD 92,000 - 120,000; Full time

Job summary

CSA Group Testing & Certification Inc. in Irvine, CA seeks a Product Safety Engineer, Medical Devices to lead safety certification projects for medical equipment.

You will apply CSA/UL/IEC standards, review complex products, and coordinate tests with lab staff to ensure regulatory compliance and timely delivery. The role requires a Bachelor's degree in Engineering with extensive experience in product certification, risk management, and strong documentation skills.

Qualifications

• Bachelor's degree in Engineering with 6+ years of related experience; or engineering tech with 8+ years.
• Thorough knowledge of CSA, UL and IEC Standards - 60601 and 61010.
• Experience in certification programs and risk management processes.
• Ability to review complex products and ensure compliance with safety standards.

Responsibilities

• Manage certification projects, ensuring compliance with safety requirements.
• Evaluate products against national/international standards and precedents.
• Review work of others and demonstrate technical competency in certification programs.
• Collaborate with lab staff to plan tests, samples, and test sequences.
• Prepare and sign Certification Reports and Certificates of Compliance.

Skills

Communication skills

Project management

Engineering drawings

Standards knowledge

Lab testing proficiency

Education

Bachelor's degree in Engineering

Tools

Microsoft Office

Lab equipment handling

Job description

CSA Group Testing & Certification Inc. in Irvine, CA seeks a Product Safety Engineer, Medical Devices to lead safety certification projects for medical equipment.

You will apply CSA/UL/IEC standards, review complex products, and coordinate tests with lab staff to ensure regulatory compliance and timely delivery. The role requires a Bachelor's degree in Engineering with extensive experience in product certification, risk management, and strong documentation skills.