Technical Lead
Job Specification
We are seeking an experienced engineering professional for a 6‑month contract position beginning in March. This role is designed for a senior-level individual who brings extensive expertise in process validation, process development, and new product introduction (NPI) within a highly regulated manufacturing environment. The successful candidate will play a key leadership role in supporting the transition of new medical devices into full-scale commercial production.
A core part of the role involves providing technical leadership and direction to junior and mid‑level engineers, ensuring that validation activities are executed to a high standard while maintaining appropriate documentation and compliance with all relevant quality and regulatory requirements. The engineer will oversee process characterisation, validation strategy development, execution of IQ/OQ/PQ protocols, and the resolution of issues arising during engineering and production builds. The position will focus heavily on driving manufacturing readiness, optimising processes, and supporting the ramp‑up of production to meet commercial demand.
The ideal candidate will have specific experience in the development or introduction of catheter-based medical devices, including hands‑on involvement with complex assemblies, materials, and process technologies relevant to catheter manufacturing. Practical experience addressing yield improvements, process capability challenges, and scaling constraints will be essential. Familiarity with design transfer and collaboration with cross‑functional teams-including R&D, Quality, Operations, and Supplier Engineering-is also expected.
Candidates who have previously worked at companies such as Boston Scientific in a Process Development capacity or at Stryker in an Advanced Operations (AO) role will be particularly well aligned with the requirements of this position, as these environments closely mirror the type of product development and process scale‑up experience needed.
This role requires a minimum of 10 years' industry experience, with a proven track record of successfully leading or significantly contributing to the introduction of new medical devices into manufacturing. Strong communication skills, the ability to mentor less experienced engineers, and a hands‑on, solutions‑focused mindset are essential for success.