An F200 pharma company needed an experienced principal risk management engineer to assess current processes and develop improvements to mitigate risk during development and manufacturing of medical devices and combination products. The engagement would also include continued advancement in risk assessment methods and tools, as well as alignment with standard device development practices and regulations. Looking for a consultant experienced in device design analysis, metrics generation, and risk reporting, the Director of Systems Engineering and Risk Management turned to Business Talent Group.
BTG delivered a former F200 healthcare and device quality engineer with deep experience in device design controls and risk analysis methods such as FMEA. The consultant was able to work cross-functionally with teams including clinical and patient safety to facilitate strong communication and further drive system safety into product design. She delivered regular risk management plans and production control evaluations, risk-benefit reports, and end-user hazard analyses, allowing the company to stay ahead of the curve on medical device safety and design.