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Kelly Services Biocompatibility Senior Engineer in Mansfield, Massachusetts

Industry leading Pharmaceutical Company located in Mansfield, MA is currently hiring a Biocompatibility Senior Engineer to join our team.

Advancement opportunities available for career minded individuals.

Immediate Benefits available:

Medical, Dental, Vision, 401K, Vacation, Sick Time, and Holiday Pay

Job Title: Biocompatibility Senior Engineer

1st Shift: 9AM-5PM

Pay Rate: $40-$50 dependent upon experience

Location: Mansfield, MA

The Biocompatibility Senior Engineer will be responsible for Biocompatibility, Extractable & Leachable (E&L) and Biocompatibility Testing report activities, which includes classification of the product category, interpretation of the applicable regulatory guidance and standards for each product category.

Job Description:

  • Provide Biocompatibility assessment for vast majority of products falling into the category of Medical Devices

  • Define applicable Biocompatibility tests to evaluate product compliance to ISO10993 standard

  • Assure product biocompatibility to comply with EUMDR regulations

  • Work with outside laboratory on Biocompatibility test definitions and arrangements

  • Write final Biocompatibility assessment reports

Qualifications:

  • BS or MS degree in Biology/Chemistry or equivalent is preferred

  • Min 5-year experience working in Medical Device industry is a must

  • Knowledge of ISO10993 is a must

  • Experience working with test laboratories for Biocompatibility product assessment

  • Experience working with product development engineering to identify appropriate representative of product families

  • Excellent writing and communication skills

  • Experience supporting regulatory submissions in the scope of Biocompatibility

Please submit an up to date resume for immediate consideration.

Thank You

Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.

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