Product Safety Engineer- Medical Device

Eurofins USA
Published
September 8, 2021
Location
Union City, CA
Category
Job Type

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 Organization 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 Organizations. The Group also has a rapidly developing presence in highly specialized 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 decentralized 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.

In 2020, Eurofins generated total revenues of EUR € 5.4 billion, and has been among the best performing stocks in Europe over the past 20 years.

Job Description

Core 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:

  1. Serve as customer technical contact.
  2. Interpret standards and apply the requirements to products under investigation.
  3. Create and implement test procedures.
  4. Conduct tests in accordance with standards and procedures, record results.
  5. Ensure that test equipment is calibrated or tested and operates properly.
  6. Interface with and update the Lab Director and/or Technical Manager.
  7. Supervise technicians in training, qualified technicians, assistant to project engineer, and other project engineers.
  8. Conduct training of subordinate personnel and monitors training conducted by other personnel.
  9. Review files and reports prepared by project engineers.
  10. Monitors multiple projects underway.
  11. Prepare certification reports and related documents.
  12. Assists department management with quoting.
  13. Assist Sales with closing new work.
  14. 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 Information

Position 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 holidays

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

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

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