Product design owner

A leading global provider of innovative medical technologies focused on hemodynamic monitoring and fluid management solutions.

The company delivers advanced diagnostic and monitoring tools designed to improve patient outcomes in critical care settings. Its products are widely used by healthcare professionals to support precise and timely clinical decision-making.

The organization emphasizes innovation, quality, and collaboration with medical practitioners to address complex healthcare challenges worldwide.

Key Responsibilities:

• 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

Requirements-

• 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