Hi Friends,

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: MDR Regulatory Engineer*

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

*Duration: Long Term Contract*



*Job Description:*

•    Creating / updating design documentation in preparation for new MDR
regulations/ Design history files (DHF)

•    Generate test protocols, analyze test data, and generate written
reports.

•    Verification and validation activities for new/replacement and
existing products and components.

•    Lead and participate in design and technical phase reviews.

•    Working knowledge of U.S. FDA Medical Device GMP and ISO requirements
for the design, validation, manufacturing processes, secondary operations
and assembly of medical components and devices preferred

•    Effective written and oral communication skills

•    Good organizational and planning skills; drives for results

•    Effective analytical/problem solving skills

•    Good interpersonal skills that include working well in a team
environment and the ability to lead others

•    Ability to exercise reasonably independent judgment and discretion
within a defined range of policies and practices

•    Ability to handle multiple tasks and to prioritize/schedule work to
meet business needs with routine supervision

•    Working knowledge of international requirements and quality systems

•    Intermediate knowledge of Microsoft Office suite - Word, Excel,
PowerPoint



*Education / Experience Requirements*

•    Bachelor of Science – Biomedical Engineering or equivalent technical
discipline

•    2-3 years of previous experience in development engineering,
sustaining engineering or project management in medical device preferred or
related fields (e.g. FDA regulated industry)

•    PMP certification or relevant experience managing complex projects
with a multi-functional team



Thanks & Regards,

Sai Kiran Nandrolu

Sr. Recruiter

W: (972) 393-2255

E:  saikiran.nandr...@w3global.com

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

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