Sound understanding of key regulations and best practices for medical device risk management and human factors (e.g. 14971, IEC 62366, AAMI HE75, FDA Applying Human Factors and Usability Engineering to Medical Devices, FDA Combination Products Guidances)
Ability to analyze and synthesize qualitative and quantitative usable data.
Ability to prioritize and multi-task in a fast-paced, collaborative work environment.
Experience supporting human factors /usability engineering Risk in medical device, combination products, biotech industry.
Day to Day Responsibilities:
Provide Use-related risk management support across multiple programs.
Support Hazard identification, risk analysis, complaint investigations of internal products, collection and synthesis of data for design inputs, FDA responses, task analysis, Identification of critical tasks, and product validation for combination and non-combination products.
Conduct risk sessions using DAI process.
Identify Risk and provide solutions.
Primary responsibility for creating and maintaining usability risk analyses for combination and non-combination products working closely with Device Engineering, Device Quality, extended Risk team, Global Safety, Regulatory, and Human Factors / Usability Engineers.
? Supporting documentation review and development, including but not limited to hazard analysis, use risk analyses, task analyses, use specifications, safety assurance cases, uFMEAs, root cause analysis, traceability of risk mitigations and controls, and Human Factors Engineering reports to support regulatory filings.
?Work with complaints team to analyze on-market product complaints using risk-based decision making, and update usability risk assessment and escalate usability-related issues as necessary
Sound understanding of key regulations and best practices for medical device risk management and human factors (e.g. 14971, IEC 62366, AAMI HE75, FDA Applying Human Factors and Usability Engineering to Medical Devices, FDA Combination Products Guidances) and advise management regarding potential improvements to internal Risk Management processes related to usability engineering
"This posting is for Contingent Worker, not an FTE