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Product Safety Engineer III - Medical Devices (Irvine), Irvine
Client: CSA Group
Location: Irvine, United Kingdom
Job Category: Other
EU work permit required: Yes
Job Reference: b7576f0acc08
Job Views: 13
Posted: 12.08.2025
Expiry Date: 26.09.2025
Job Description:
Employment Type: Permanent
Hours: Full-time
We are forming a world-class team at CSA Group, a global leader in standards development, testing, inspection, and certification since 1919. Our mission is to make the world a safer, better, and more sustainable place through our standards and services.
We are seeking an experienced Product Safety Engineer, Medical Devices to join our Irvine, CA office. This role offers growth potential for a systematic, detail-oriented individual capable of managing multiple projects and understanding the big picture, reporting directly to the Product Group Managers.
As medical technology evolves, so does the need for safety standards and risk management in product design and certification. The Product Safety Engineer will oversee the safety certification of innovative medical products based on CSA Group and other recognized standards.
Responsibilities:
1. Manage multiple certification projects independently, ensuring compliance with safety standards, within time and budget constraints.
2. Review product compliance against national/international standards and previous decisions.
3. Demonstrate technical expertise in certification processes and review work of others.
4. Evaluate complex, unique, or unusual product types accurately.
5. Maintain high productivity and manage multiple projects efficiently.
6. Review test data, reports, and authorize Certification Marks; prepare Certification Reports and Certificates of Compliance.
7. Conduct construction evaluations to ensure compliance with standards.
8. Collaborate with Lab Technicians to plan testing and sample requirements.
Education:
Bachelor's Degree in Engineering with 6+ years of relevant experience, or Degree/Diploma in Engineering Technology with 8+ years of experience.
Experience:
Thorough knowledge of standards, testing procedures, and certification options, especially CSA, UL, and IEC standards 60601 and 61010.
Skills:
* Strong interpersonal, communication, organizational, and project management skills.
* Ability to work independently and in teams, interpret engineering drawings, and use lab equipment and MS Office.
* Detail-oriented with the ability to manage complex projects and think innovatively.
* Ability to work across diverse teams and cultural boundaries, aligning with CSA Group’s mission and values.
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