Hi Friends,


I hope you are doing great,



I have an urgent requirement from one of my esteem client, I will
appreciate if you can have an eye on the below requirement and send me your
consultant updated profile ASAP.



*Job Title: Biocompability Engineer*

*Location: Maple Grove, MN / Morrisville, NC*

*Duration: Long Term Contract *



*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
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 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 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.



*Skill Matrix:*

*Technical / Soft Skills*

*Expertise Level (Expert / Good / Knowledge)*


* Years of Experience *

MDR regulations





Engineering Design





Quality Management







Thanks & Regards,

Sai Kiran Nandrolu

Sr. Recruiter

W: (972) 393-2255

E:  [email protected]

A:  1701 Legacy Dr, Suite#1000, Frisco, Texas - 75034

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