Medical Device Risk/Validation Engineer

Denver, CO

Industry: Medical Device Job Number: 147389

 

Medical Device Risk/Validation Engineer

Environment:

Our client is a large medical device manufacture of Class II devices. They were acquired over a year ago by another company and are undergoing remediation of their risk management classifications. They need an engineer to support work around PFMEA, EFMEA, Product Hazard Analysis, etc.

Principle Duties and Responsibilities:

This person will be supporting R&D integration efforts, including the remediation of Risk Files of legacy products. Activities include creating of Risk Management Matrix, converting from legacy FMEA template’ s to new FMEA templates, assess risks to new risk classifications, identify gaps in  previous verification and validation activities and then address gaps as needed.

This person will need to:

Create Risk Management Matrix for legacy products, using the PHA’ s, DFMEA, UFMEA and complaint history. 
• Convert legacy UFMEA, DFMEA and PFMEA into new templates, developing language that is more patient focused. 
• Reassess Risk Classifications using new templates and identify where Risk Classifications have increased.
• Identify gaps in verification, validation or component qualification testing occur due to a change in Risk Classification and develop and execute a plan to close gap. 
• Collaborate with Development Engineering and Design Assurance Engineering stakeholders to develop strategies and review work. 
• Tracks and reports progress and will communicate any identified risks or delays to projects. 

THis person may work with Process Validation and Design Verification- both report writing and execution of testing and requalification. 

Required:
  • Must have experience in applying Risk Management using a life cycle approach. 
  • Write design verification reports
    • Working knowledge of 21 CFR 820, ISO 13485, and ISO 14971. 
    • Experience creating FMEA’ s, writing test protocols and reports and developing engineering justifications. 
    • Experience with MS Word and MS Excel. 

Job Type: Contract 

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