Medical Device Manufacturing Engineer (Product Remediation)

Denver, CO

Job ID: 131504 Industry: Medical Device

Medical Device Manufacturing Engineer (Product Remediation)

Environment:

Our client is a large medical device manufacturer. They develop and manufacture a number of cardiac medical devices. They are looking to bring in a  manufacturing engineer to perform validation and product remediation activities.

Scope of Work:

The Manufacturing Engineers will work on an energetic and lively cross functional team with diverse strengths in the final stages of implementation for our process validation, execution of CAPA action plans, and design verification testing and reporting. 

Successful engineers on our team are intensely curious, able to dig deep for root cause, analyze objectively, draw logical conclusions and follow through quickly to deliver solutions. We seek detail oriented folks with good technical writing skills and a critical eye to quality who can help us ensure the documentation we produce is fully supported, accurate, and well written. We seek passionate people with a positive mental attitude who can interact with ease within and outside our team to develop and deliver win-win solutions. 

Knowledge of Master Validation Plans, Installation Qualification (IQ), Operation Qualification (OQ), and Performance Qualification (PQ), Software validation, test method validation, Gage R&R, and a clear understanding of FDA’ s QSR and cGMP, and a good grounding in statistics would be a big plus. 

Job Type: Contract

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