Project Manager - Medical Device


Manages Others
Experience Required
Degree Required
Employment Type
Work Schedule
Full-Time Permanent

Job Description

Project management:
• Experience in creating project plan, resource plan and project risk management
• Collaborate with project leadership on identification and allocation of activities between internal and external resources and assign work accordingly
• Collaborate with project stakeholders identification EU-MDR deliverables
• Understand MDR impacts to assigned product portfolio and communicate to team members accordingly
• Coordinate priorities with other EU MDR work streams to feed into the overall success of the EU MDR program
• Tracks progress of product development in the context of the program
• Has a combination of global and regional accountability
• Responsible for conducting a Gap assessment as per current risk management documentation & trace matrices against new EU MDR Standards
• Excellent Communication & Interpersonal skills in coordinating, project planning, scheduling, tracking and interaction with cross-functional teams,
• Responsible for overall delivery of the project

Technical experience:
• Hands on experience in Manufacturing engineering / process engineering for medical devices / similar mechanical component
• Hands on experience in Equipment qualification / Process validation / Test methods validation / Risk management
• Hands on experience in change control process (ECO process) to introduce new changes to the existing manufacturing processes
• Hands on experience in documentation such as protocols, manufacturing controls plan & test reports
• Hands on experience in creating risk management document such as pFMEA
• Expert in Process validation / Cleanroom Packaging process / Cleanliness / Foundry process / mechanical manufacturing process
• Good knowledge in CTQ, Control Plan & Validation Plan Documentation
Job Requirements
Additional preferences
• Knowledge on exp. in Process transfer / new product introduction
• Experience in GAP Assessment and reports
• Knowledge in ISO13485 / EUMDR / 21CFR regulations
• Knowledge in root cause analysis using any suitable quality tools

High Staff Recruitment

Europe Other Countries