Medical Device Safety Engineer I

CSA Group Testing & Certification Inc.; Irvine (CA); On-site; USD 71,000 - 93,000; Full time

Job summary

CSA Group is seeking an experienced Product Safety Engineer, Medical Devices in Irvine, CA to lead certification projects and ensure compliance with national and international standards. You will review devices, prepare reports, and collaborate with lab teams and clients to deliver timely, cost-efficient certifications.

The role requires a Bachelor's in Electrical or Biomedical Engineering with 2+ years of experience (or equivalent).

Qualifications

• Bachelor’s in Electrical or Biomedical Engineering with 2+ years of experience, or an Associate Degree with 3+ years’ experience.
• Thorough knowledge of Standards and testing procedures; familiarity with CSA, UL and IEC 60601/61010 is a plus.
• Strong communication, documentation, and project management skills.

Responsibilities

• Independently manage certification projects ensuring compliance with safety requirements and deadlines.
• Evaluate products against national/international standards; review technical documents.
• Prepare and sign Certification Reports and Certificates of Compliance.
• Collaborate with Lab Technician to plan tests and determine sample requirements.

Skills

Read drawings

Microsoft Office

Interpersonal skills

Project management

Detail oriented

Team collaboration

Education

Bachelor's Degree in Electrical or Biomedical Engineering

Associate Degree / Diploma in Electrical Engineering Technology

Tools

Electrical lab equipment

Job description

CSA Group is seeking an experienced Product Safety Engineer, Medical Devices in Irvine, CA to lead certification projects and ensure compliance with national and international standards. You will review devices, prepare reports, and collaborate with lab teams and clients to deliver timely, cost-efficient certifications.

The role requires a Bachelor's in Electrical or Biomedical Engineering with 2+ years of experience (or equivalent).