We are looking to recruit an experienced manufacturing Project Manager to join our client's team on a permanent basis.
The Project Manager is responsible for the controlled execution of medical device tooling and NPI programmes from customer handover through tooling development, process development, validation, and release to serial production. The role ensures projects are delivered on time, to cost, and to defined quality and regulatory requirements in compliance with ISO 13485.
KEY JOB RESPONSIBILITIES
- Project Planning & Execution
- Manage assigned projects from handover through serial production release
- Develop and maintain project plans, milestones, and timelines
- Ensure adherence to approved NPI phase-gate processes
- Cross-Functional Coordination
- Coordinate tooling, process development, metrology, quality, operations, and supply chain
- Facilitate project meetings and technical reviews
- Risk Management & Control
- Maintain project risk registers
- Identify, assess, and elevate technical, quality, and schedule risks
- Tooling & Process Development Oversight
- Coordinate tooling design reviews, manufacture, trials, and steel tuning
- Support process development and optimisation activities
- Validation & Production Release Support
- Coordinate IQ/OQ/PQ or PPQ activities
- Support FAI and capability studies
- Ensure validation approvals prior to production release
- Change Control & Configuration Management
- Ensure all project changes are formally assessed and approved
- Maintain configuration control of drawings and specifications
- Customer Communication & Reporting
- Act as primary customer contact for assigned programmes
- Provide regular project updates and milestone reporting
- Documentation & Record Control
- Maintain complete and accurate project documentation
- Ensure objective evidence is available for audits
- Issue Resolution & Escalation
- Drive issue resolution and escalating when required
- Audit & Compliance Support
- Support internal, customer, and regulatory audits
COMPETENCE, SKILLS & EXPERIENCE
Essential
- Medical device project management experience
- ISO 13485 knowledge
- Injection moulding or tooling exposure
- Strong planning and communication skills
Desirable
- Engineering or manufacturing qualification
#J-18808-Ljbffr