Lead Medical Device Product Safety Engineer

CSA America Testing & Certification LLC; Cleveland (OH); On-site; USD 100,000 - 123,000; Full time

Job summary

CSA Group is seeking an experienced Product Safety Engineer, Medical Devices to join our Irvine, CA office. You will lead certification projects, review complex product types against CSA/UL/IEC standards, and collaborate with lab teams to plan testing and documentation.

Strong engineering background and risk management are essential. The role offers growth, exposure to global medical device standards, and a pathway to advanced certification services for manufacturers.

Qualifications

• Bachelor's Degree in Engineering with 6+ years of job related experience; or Degree / Diploma in Engineering Technology with 8+ years' experience.
• Thorough knowledge of Standards and testing procedures.
• Knowledge of CSA, UL and IEC Standards - 61010 and 60601.
• Thorough knowledge of CSA certification options, programs and services applicable to a variety of equipment.

Responsibilities

• Independently manage certification projects concurrently ensuring compliance with all applicable safety requirements achieving completion within time frames and cost deadlines.
• Evaluate products against requirements of the national / international standards and precedent decisions.
• Demonstrate technical competency to review the work of others.
• Demonstrate technical competency in their respective certification programs.
• Able to accurately perform evaluation and review of complex, unique or unusual product types.
• Demonstrates the ability to consistently manage multiple projects concurrently while maintaining on-time and on-budget performance.
• Reviews test data, reports and authorizes application of Certification Marks.
• Prepares and / or signs Certification Reports and Certificates of Compliance.
• Conduct construction evaluation, ensuring the unit complies with the construction section of the standard; identifies rationale for compliance or non-compliance.
• Collaborate with Lab Technician to create a work order which test are required and; the order of the tests and the number of samples required.

Skills

Interpersonal skills

Customer service

Organizational skills

Time management

Project management

Reading engineering drawings

Microsoft Office

Analytical thinking

Education

Bachelor's Degree in Engineering

Tools

Microsoft Office

Job description

CSA Group is seeking an experienced Product Safety Engineer, Medical Devices to join our Irvine, CA office. You will lead certification projects, review complex product types against CSA/UL/IEC standards, and collaborate with lab teams to plan testing and documentation.

Strong engineering background and risk management are essential. The role offers growth, exposure to global medical device standards, and a pathway to advanced certification services for manufacturers.