Product Certification Safety EE Lake Forest, CA **Onsite** Contract $60/hr - $75/hr Our client, located in South Orange County, is oine of the largest medcical device makers within the optical surgery space. They are urgently seeing a Labortory Product Safety Engineer to work handson in their Labs on the medical devices. They continue to grow their departments and add new engineers monthly. **This is a hybrid 4x a week onsite position, so they would need to be local to the south orange county area or norther San Diego.** **Role Requirements:** 1. Minimum Education and Experience: BS + 4+ years in medical device products safety compliance, and/or fully accredited test labs such as UL, CSA, Intertek or Element, etc. 1. Working knowledge of IEC 60601-1 3rd Ed (3.1 and 3.2) of medical electrical equipment standards and including particulars & collateral standards. 2. 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. **The Offer:** + 65-75 /hr pay rate DOE + W2 Employee Benefits + potential for full-time offer after the contract is over. Motion Recruitment partners **You will receive the following benefits:** + Medical Insurance - Four medical plans to choose from for you and your family + Dental & Orthodontia Benefits + Vision Benefits + Health Savings Account (HSA) + Health and Dependent Care Flexible Spending Accounts + Voluntary Life Insurance, Long-Term & Short-Term Disability Insurance + Hospital Indemnity Insurance + 401(k) including match with pre and post-tax options + Paid Sick Time Leave + Legal and Identity Protection Plans + Pre-tax Commuter Benefit + 529 College Saver Plan Motion Recruitment Partners (MRP) is an Equal Opportunity Employer. All applicants must be currently authorized to work on a full-time basis in the country for which they are applying, and no sponsorship is currently available. Employment is subject to the successful completion of a pre-employment screening. Accommodation will be provided in all parts of the hiring process as required under MRP’s Employment Accommodation policy. Applicants need to make their needs known in advance. **Posted by:** Kevin Morley **Specialization:** + Product Security