Operations Engineer II - Medical Device Start-up
Our ideal candidate will play a pivotal role in establishing, optimising and scaling manufacturing operations for cutting-edge medical devices.
Key Responsibilities:
* Lead and support the development, optimisation and validation of new and existing manufacturing processes for medical device products.
* Collaborate with R&D, Quality and Supply Chain to support New Product Introduction (NPI) and design transfer into manufacturing.
* Develop and document manufacturing procedures, work instructions and test protocols to ensure consistent product quality and compliance.
As an Operations Engineer II, you will be responsible for:
Process Development and Validation:
* Plan and execute process validation activities (IQ/OQ/PQ) and associated documentation.
* Identify and implement process improvements to enhance yield, reduce costs and increase efficiency.
Collaboration and Communication:
* Cultivate strong relationships with internal and external partners, including suppliers and contract manufacturers, to ensure effective scale-up and production readiness.
* Support manufacturing during audits and inspections as a subject matter expert for assigned processes.