Eurofins

Senior Product Safety Project Medical Engineer

Cary, NC, US

In-personFull time roleSenior Level

About 1 month ago

About the Job

Reports to: Director of East Coast Safety or Engineering Manager along with Chief Engineer, Medical

Department: Medical Safety Business

Tasks/Responsibilities:

Serve as a customer technical contact.
Interpret medical standards and apply the requirements to products under investigation; including but not limited to IEC/EN/AAMI/CSA 60601-1, ISO 14971, IEC 60601-1-6.
Create and implement test plans; conduct the required tests in accordance with the applicable standard(s), procedures and ensure results are documented.
Ensure that test equipment is calibrated or tested and operates properly.
Interface with and update the lab manager.
Review files and reports prepared by other project engineers; including but not limited to peer reviews.
Conduct preliminary design reviews.
Monitor multiple projects.
Prepare certification reports and related documents (e.g., approval letters, test report forms, etc.).
Assists department with quoting medical projects.
Assist Sales with closing new work.

About the Company

Eurofins

Luxembourg, Luxembourg

5000 +

<div class="org-about-module__description"> <div id="ember58" class="ember-view organization-about-module__content-consistant-cards-description"><span class="lt-line-clamp__raw-line">Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and the environment safer, healthier and more sustainable. From the food you eat to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. Eurofins is a global leader in food, environmental, pharmaceutical and cosmetic product 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, CDMO, advanced material sciences and in the support of clinical studies. Since 1987, Eurofins has grown from one laboratory in Nantes, France to ca. 62,000 staff across a network of independent companies in 62 countries, operating over 900 laboratories. Performing over 450 million tests every year, Eurofins offers a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products, as well as providing innovative clinical diagnostic testing services, as one of the leading global emerging players in specialised clinical diagnostics testing. Ever since its IPO on the French stock exchange in 1997, Eurofins has been one of the fastest growing listed European companies.</span></div> </div> <div class="org-about-module__content-improvement"> <div class="org-about-module__content-box"> </div> </div>

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