NPI Engineering Team Lead – Medical Devices

About this role

We are seek an NPI Engineering Team Lead – Medical Devices to join our Engineering Team in Ballytivnan. In this role,you will lead a team of engineers and technicians responsible for introducing new medical device products, technologies, equipment, materials, and manufacturing processes. You will work closely with Operations, Quality, Maintenance, EHS, suppliers, and cross-functional project teams to deliver projects from concept through design, commissioning, validation, and handover to production.

Key Responsibilities Lead and develop the NPI engineering team, supporting capability building and technical development. Manage new product introduction projects to meet quality, budget, schedule, and compliance requirements. Provide technical leadership in injection moulding, automated assembly, tooling, equipment, and process development. Support equipment and process trials, troubleshooting, qualification, and validation activities.

Introduce and optimise manufacturing technologies, automation, and ancillary equipment. Partner with Operations to improve yield, downtime, equipment performance, and production delivery. Work with equipment suppliers and cross-functional teams to resolve technical issues. Support knowledge transfer, training, continuous improvement, and Maintenance Excellence initiatives. Ensure documentation and activities comply with cGMP, ISO, FDA, EHS, and site requirements.

Level 7 qualification or higher in Engineering or a related technical discipline. At least three years’ experience in a high-precision manufacturing environment. At least two years’ experience in regulated manufacturing. Strong experience in injection moulding, including process setup, development, debugging, and validation. Experience with medical device components, automated assembly, tooling, and equipment introduction.

Knowledge of thermoplastics, cleanroom manufacturing, and validation documentation. Proven ability to lead teams and work effectively with cross-functional stakeholders. Strong problem-solving, communication, organisational, and decision-making skills. Commitment to quality, compliance, safety, and Right First Time principles. Desirable: Experience with PLC programming, Lean or SMED methodologies, statistical analysis, Microsoft Project, and Maintenance Excellence programmes.