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Medical Product Safety Engineer/Subject Matter Expert

Company: Eurofins USA
Location: Union City
Posted on: January 12, 2021

Job Description:

Eurofins Scientific is an international life sciences company which provides a unique range of analytical testing services to clients across multiple industries. The Group believes it is the world leader in food, environment and pharmaceutical products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and for supporting clinical studies. In addition, Eurofins is one of the key emerging players in specialty clinical diagnostic testing in Europe and the USA.Group's key figures (as of March 2019) are approx. 3.8 billion Euros turnover, over 800 laboratories across 47 countries and about 45,000 staff.Job DescriptionCore Responsibilities:* Develop world-class testing and certification within the electrical medical product industry.* Identify and obtain the required test equipment.* Identify and acquire necessary test fixtures.* Recommend and oversee facility changes such as buildouts or additional space needed to accommodate testing.* Mentor/train other staff.* Attain appropriate accreditations.* Recommend and participate in relevant industry events, forums, shows, technical committees, and the like as necessary.* Quote projects, assist with and/or review quotes prepared by others.* Perform evaluations, testing, and reporting.* Assist others with evaluations, testing, and reporting.* Peer review the work of other engineers.* Continuously develop new capabilities while maintaining existing capabilities.* Serve as a customer technical contact in support of other engineers assigned to relevant projects.* Other duties as assigned by management.Additional Duties as a Product Safety Engineer:- Serve as customer technical contact.- Interpret standards and apply the requirements to products under investigation.- Create and implement test procedures.- Conduct tests in accordance with standards and procedures, record results.- Ensure that test equipment is calibrated or tested and operates properly.- Interface with and update the Lab Director and/or Technical Manager.- Supervise technicians in training, qualified technicians, assistant to project engineer, and other project engineers.- Conduct training of subordinate personnel--and monitors training conducted by other personnel.- Review files and reports prepared by project engineers.- Monitors multiple projects underway.- Prepare certification reports and related documents.- Assists department management with quoting.- Assist Sales with closing new work.- Other duties as assigned by management.Qualifications* BSEE or other technical degree and relevant experience.* Five or more years of experience performing product safety evaluation and testing on medical projects using US, Canadian and international standards.* Five or more years providing technical management of a team performing product safety evaluations and testing on medical electrical equipment.* Experience developing personnel and laboratory technical capability, setting up a lab, and obtaining accreditations for medical safety standards.* Strong knowledge of the certification schemes common for electrical medical products as well as broad knowledge of the standards that apply to these products.Additional InformationPosition is full-time, Monday-Friday, 9--a.m.-5--p.m., with overtime as needed. What we Offer:* Excellent full-time benefits including comprehensive medical coverage, dental, and vision options* Life and disability insurance* 401(k) with company match* Paid vacation and holidaysEurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.

Keywords: Eurofins USA, Union City , Medical Product Safety Engineer/Subject Matter Expert, Other , Union City, California

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