Project Manager

Description

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 escalate 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 escalate 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

Ad ID: 5419342134