Engr 3

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Job description

This role will primarily be responsible for remediating Risk Management Files for medical devices to ensure compliance with ISO 14971:2019. The effort will consist of development of new and/or updating existing risk management deliverables and hazard analyses which currently comply to ISO 14971:2007. The role will require collaboration with cross-functional teams to establish accurate hazards identification and measurements using established procedures and criteria.
Responsibilities:
•Facilitate appropriate collaboration and completion of risk management deliverables including, but not limited to:
oPreliminary Hazards List
oRisk Management Plan
oSystem Hazards Analysis
oRisk Management Report
•Review and collaborate on other risk management deliverables including, but not limited to:
oHealth Hazard Analysis
oFault Tree Analysis
oFailure Modes and Effects Analysis
oBenefit Risk Analysis
•Conduct hazards analysis using available historical, test and market data related to the product.
•Provide timely updates to the business regarding remediation effort.
Qualification/Skill Set:
•Strong cross-functional collaboration skills needed.
•ISO 13485 and ISO 14971 experience a plus.
•Risk management experience (preferred).
•Experience in medical device and/or regulated industry (preferred).
•Technical experience with Pyxis or automated dispensing cabinets (preferred).
•Typically requires Bachelor's degree and/or 5+ years of applicable experience.