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.
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
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.
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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