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Medical Device Regulations Engineer

Company: Yoh
Location: Lewisville
Posted on: January 10, 2022

Job Description:

Medical Devices Regulations Engineer (MDR Engineer)
100% Remote

The individual in this position will support creation and update of documentation that supports product Design History Files in order to reach compliance with the European Union's Medical Device Regulation (MDR). Documents that are included in the range originate from various cross-functional departments including Project Management, Product Development, Design Quality, Manufacturing Engineering, Supply Chain and Regulatory Affairs. The individual must have a general understanding of product development processes (e.g., Development, Risk Management, Verification and Validation) and Design Controls required in the Medical Device Industry. Prior experience documentation including Failure Modes and Effects Analysis (FMEAs), Trace Matrices, User Needs, Design Requirements, and Design Verification and Validation activities are important for the successful candidate.

RESPONSIBILITIES (essential functions of position):
Creation and update of plan documents for design, risk management, verification and validation.
Review and update of Hazard Analyses.
Review and update of User Needs, Design Requirements, and the associated Traceability Matrices.
Review of testing performed and standards to verify design requirements have been met.
Review of testing performed to validate user needs have been met.
Identification of new testing, or justification for not testing, where appropriate.
Creation and update of test protocols and reports.
Review of contact materials to identify substances of potential concern (CMR/ED).
Creation and update of summary reports for risk management, verification, and validation.
Review lab tests to confirm protocol criteria have been met.
Review of process validations to confirm manufacturing capabilities have been appropriately established.

Demonstrate they possess an Associate's Degree or higher degree in relevant engineering or technical field.
Perform at a level representative of a minimum of two years of formal medical device engineering experience.
Listen intently to what other people are saying, taking time to understand the points being made, asking questions when appropriate, and allowing others to speak without interrupting them.
Communicate information and ideas through speaking and writing so that others will understand.
Act professionally and respectfully toward colleagues.
Professionally communicate by means of email and video conferencing.
Utilize computer skills using Microsoft Office Suite programs
Analyze complex problems, interpret functional needs, and develop integrated solutions.


Keywords: Yoh, Lewisville , Medical Device Regulations Engineer, Healthcare , Lewisville, Texas

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