Product Safety Engineer
Job in
Dallas, Dallas County, Texas, 75215, USA
Listed on 2026-06-27
Listing for:
Laiba technology
Full Time
position Listed on 2026-06-27
Job specializations:
-
Engineering
Quality Engineering, Medical Device Industry, Biomedical Engineer
Job Description & How to Apply Below
- Perform product safety testing and compliance activities for new and existing medical devices.
- Execute and support testing per UL/CSA/IEC 61010-1, 61010-2-101, and related standards.
- Participate in UL witness testing and manage interactions with UL and EU Notified Bodies.
- Conduct regulatory impact assessments and provide design recommendations to engineering teams.
- Create and maintain laser safety reports (IEC 60825-1, FDA/CDRH Form 3632).
- Support ISO 17025 compliance, quarterly UL audits, equipment calibration, and audit readiness.
- Develop and maintain internal safety test procedures and laboratory capabilities.
- Bachelor's degree in Engineering or a related discipline.
- 6+ years of experience in Product Safety, laboratory testing, field service, or medical device environments.
- Strong knowledge of Product Safety standards, testing methods, and regulatory requirements.
- Experience with EMC/Safety assessments and regulatory compliance activities.
- Excellent communication, documentation, and organizational skills.
- Bachelor's degree in Electrical, Mechanical, or Biomedical Engineering.
- 6+ years of Medical Device Product Safety Testing experience.
- Experience working with Abbott Diagnostics products is highly preferred.
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