What are the responsibilities and job description for the Product Safety Engineer position at GTECH LLC?
Hello Connections,
We have an urgent job requirement from our prime client. If you have relevant experience, Please share the resume at abhardwaj@greattechglobal.com
Role: Product Safety Engineer
Location: Lake Forest, CA
Job Type: Full-time
Role Requirements:
- BS (preferably in EE or similar major) 4 years in medical device products safety compliance evaluations, and/or fully accredited test labs such as UL, CSA, Intertek or Element, etc.
- Expert knowledge of IEC 60601-1 3rd Ed (3.1 and 3.2) of medical electrical equipment standards and including particulars & collateral standards. Proven experience in application to EM medical devices.
- Perform Safety certification test assessments throughout the development lifecycle including early stages to provide the necessary inputs to R&D to drive product development.
- Capable of performing safety testing in safety Lab and external labs.
- Prepare documentation to execute safety certification activities – Isolation Diagrams, perform Dielectric and Leakage current testing, Construction evaluation using IEC generated test reports forms.
- Collaborate with teams to ensure full execution of identified required testing and review activities needed to ensure product compliance including de-risking product launches through pre-verification test rehearsals.
- Document and execute all V&V tests compliant to medical device QSR, ISO 13485. Prepare clearly written, accurate, highly detailed Safety verification test plans and test reports.
- Effectively communicate complex concepts in formal/informal presentations and in technical reports; proven technical writing skills is required (assessed during interview).
- Working knowledge of ISO 14971 Risk Management for Medical Devices in medical device products safety compliance, and/or fully accredited test labs.
- Strong familiarity with EMC test planning and procedures per IEC 60601-1-2 and associated test practice
Thanks and Regards,
GTECH LLC
Ashutosh Bharadwaj | Senior Technical recruiter
