| Safety Engineers-----Lake Forest, CA (Onsite)-----Long Term Contract at Lake Forest, California, USA |
| Email: [email protected] |
| From: Shekhar Bhadauria, TEK Inspirations LLC [email protected] Reply to: [email protected] Hi, We have an urgent opening with Safety Engineers and I have sent you job description, please go through it and let me know your comfort with it and also send me your updated resume ASAP Title: Safety Engineers Location: Lake Forest, CA (Onsite) Type: Long Term Contract Job Description: 1. Minimum Education and Experience: BS + 2 years in medical device products safety compliance, and/or fully accredited test labs such as UL, CSA, Intertek or Element, etc. 2. Working knowledge of IEC 60601-1 3rd Ed (3.1 and 3.2) of medical electrical equipment standards and including particulars & collateral standards. 3. Proven experience in successfully being able to work with cross functional teams Core responsibilities: Perform Safety certification test assessments throughout the development lifecycle including early stages to provide the necessary inputs to R&D to drive product development. Support development including planning, communicate periodic status and known risks (with proposed solutions) on the projects to R&D core teams Capable of performing safety testing and of Alcon products in the Alcon 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 Communicate with internal/external labs, technicians, and design engineers to accomplish timely/valuable results at optimal cost (from Quote request to final deliverables). 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). Experience with Safety testing of electrical equipment and certification for global market access. Experience with Product Safety testing requirements and procedures. Experience with use and maintenance of commonly used safety equipment, and calibration procedures. Working knowledge of ISO 14971 Risk Management for Medical Devices in medical device products safety compliance, and/or fully accredited test labs. Keywords: rlang information technology golang California Delaware Safety Engineers-----Lake Forest, CA (Onsite)-----Long Term Contract [email protected] |
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| Tue May 07 18:31:00 UTC 2024 |