Senior Product Safety Project Medical Engineer - Eurofins

Company Description

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 our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, 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 the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services. Eurofins is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organisations. The Group also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products.

In over just 30 years, Eurofins has grown from one laboratory in Nantes, France to 55,000 staff across a decentralised and entrepreneurial network of 900 laboratories in over 50 countries. 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.

Job Description

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.

Qualifications

• Four-year engineering college degree - Biomedical or Electrical discipline preferred or three years progress towards four-year degree, or equivalent work experience.
• Prior experience performing certification for medical devices at another test, inspection and certification laboratory preferred but not required.
• Support department objectives and company goals.
• Be a team player.
• Sustain a positive, enthusiastic and professional attitude.
• Accommodate requests with a smile and "let me see what I can do" attitude.
• Adhere to manager directives.
• Maintain a professional appearance and demeanor.
• Candidate will be required to sign a non-compete agreement as part of the offer.

Additional Information

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 holidays
• Exempt/Salary position
• Monday-Friday 8:30am-5:00pm
• Will consider candidates who require sponsorship to work in the US.

Eurofins is aM/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.