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 escalation 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 escalation 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
Project Manager in England employer: Forge Talent Group
At Forge Talent Group, we pride ourselves on fostering a dynamic work environment that encourages innovation and continuous improvement. As a Senior Quality Engineer, you will benefit from our commitment to employee growth through tailored training programmes and mentorship opportunities, all while collaborating with a passionate team dedicated to excellence in quality management. Located in a vibrant area, our company offers a supportive culture that values your contributions and promotes a healthy work-life balance.
