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Medical Safety Engineer

4 months ago


Irvine, United States Eurofins USA Consumer Product Testing Full time
Job DescriptionJob DescriptionCompany Description

Eurofins are a global leader in E&E testing, inspection and certification services.

With a network of over 900 laboratories in 62 countries and over 62,000 dedicated employees, Eurofins is one of the international leaders of the testing industry.

Eurofins E&E is an international network of laboratories offering expert and unbiased product safety and approvals services for electrical and electronics products. With accredited laboratories strategically located close to European, American and Asian production hubs, our comprehensive portfolio is available to both industrial and retail clients through a single point of contact.

At our labs, over 450 million tests are performed each year to a portfolio of over 200,000 analytical methods.

 

In over just 30 years, Eurofins has grown from one laboratory in Nantes, France to over 50,000 staff across a network of more than 900 independent companies in over 50 countries and operating more than 800 laboratories. 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 specialized clinical diagnostics testing.

 In 2021, Eurofins generated total revenues of EUR € 6.7 billion, and has been among the best performing stocks in Europe over the past 20 years.

Job Description

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.  

Employee Standards:

  • 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.
  • Arrive on time, properly dressed and prepared to work.
  • Perform all duties in a timely, accurate, honest and professional manner.
  • Communicate with customers professionally and in accordance with customer service standards while maintaining confidentiality.
  • Needs to be receptive to and accepting guidance from others.
  • Ability to deal with difficult people and problems.
  • Ability to multi-task and prioritize assignments.
  • Travel as needed.

 

Physical Demands:

  • Able to sit for long periods of time.
  • Able to lift up to 30 pounds.
  • Able to work with hand tools and small power tools.


Additional Information

  • This position is can be offered as a  9-12 month long internship with possibility of conversion or a full time position for those with a degree.
  • Internship will range between full time and part-time depending on availability
  • Pay rate: $16/hr for interns, $70-85K/yr for graduates that meet preferred qualifications. 

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