Job Description :
Job Title: Biocompability Engineer Location: MN 55369, NC 27560 Duration: 18 to 24 months Job Description: Job Description ? Create a technical document that outlines the applicability of testing on file and/or outlines gaps to address? Work with other functions to determine appropriate sample(s) to produce an efficient and effective remediation plan compliant to MDR 2017/745, ISO 10993, ISO 18562, and other standards or regulations as appropriate to the project. ? Perform gap assessments of products by evaluating device BOMs to determine the applicability of test data to materials of construction. Review of historical data may also include gap assessments for any historical testing that was conducted on an inactive part of ISO 10993. ? Maintain and execute the biocompatibility program/policy for Teleflex Medical to endure all products and processes comply with the regulatory standards. ? Provide input to creating strategies to assure compliance to regulatory standards regarding biocompatibility for Teleflex Medical products. ? Ensure company documentation related to biocompatibility are maintained and updated with most current regulations, standards, and industry practices. ? Provide other departmental support as requested by immediate supervisor. ? Adhere to and ensure the compliance of Teleflex?s Code of Conduct, all Company policies, rules, procedures and housekeeping standards Education / Experience Requirements ? Minimum of a B.S. Degree in B.S. in Biology, Chemistry, Toxicology, Microbiology, or other related field. ? Minimum of 2 years of experience creating medical device biocompatibility evaluations and/or managing biocompatibility projects.

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