Technical Product Lead (Medical Devices)
- פתח תקווה
- משרה קבועה
- משרה מלאה
- Lead all technical aspects of the product in the field, including adoption of new or updated standards, customer requirements, repair needs, and new market demands
- Manage and execute updates and changes to the Design History File (DHF)
- Manage risk management elements and related documentation within the DHF, including the Risk Management File (RMF)
- Conduct risk reviews of the RMF and manage RMF changes
- Develop mechanisms for documenting and communicating changes in product risk
- Communicate product risk changes to relevant stakeholders
- Escalate new risks or hazardous situations for clinical/medical team assessment and approval
- Select relevant risks or hazardous conditions for specific treatments or products
- Manage engineering change orders (ECOs) and product families related to risk changes
- Support sales, service, and marketing teams on technical issues related to the DHF
- B.Sc. in Electrical/Mechanical engineering or equivalent is a must.
- Minimum 3 years of experience in a regulated industry, medical device filed is preferred. Product environment - mandatory
- Experience with Risk management processes
- Experience in owning a process from A to Z
- Experience with NPI
- Experience in working in a multinational env. - advantage
- Past engineering experience in at least two areas of the following - Electronics Hardware development, Embedded SW, Mechanical design
- Strong knowledge of manufacturing operations and cGMPs
Mploy