What are the responsibilities and job description for the Product Safety Engineer position at Themesoft Inc.?
Role: Product Safety Engineer
Location: Lake Forest, CA (onsite)
Duration: FullTime Job
Client: Wipro
Job Description
· 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,
Karthick Ramasamy
Lead Technical Recruiter
karthick.r@themesoft.com
