Medical Device Manufacturing Operations Engineer Role
The role of Medical Device Manufacturing Operations Engineer involves leading and supporting the development, optimisation, and validation of manufacturing processes for next-generation medical devices.
This includes partnering with cross-functional teams to support New Product Introduction (NPI) and design transfer into manufacturing, as well as developing and documenting manufacturing processes, work instructions, and test procedures to ensure consistent product quality and compliance.
* Lead the development, optimisation, and validation of manufacturing processes for new and existing medical device products.
* Collaborate with R&D, Quality, and Supply Chain teams to support NPI and design transfer into manufacturing.
* Develop and document manufacturing processes, work instructions, and test procedures to ensure robust, compliant, and efficient production processes.
* Plan and execute process validation activities (IQ/OQ/PQ) and associated documentation.
* Identify and implement process improvements to enhance yield, reduce cost, and increase efficiency.
* Support the introduction of new equipment, tooling, and fixtures, including qualification and calibration activities.
* Drive root cause analysis and CAPA initiatives to resolve manufacturing or quality issues.
* Ensure all operations comply with relevant QMS requirements, ISO 13485, and FDA 21 CFR Part 820 regulations.
* Collaborate 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 an SME for assigned processes.
* Mentor and provide technical guidance to junior team members or technicians as required.
To be successful in this role, you will need a Bachelor's Degree in Engineering (Manufacturing, Mechanical, Biomedical, or related discipline) and at least 3 years' experience in a medical device manufacturing or operations engineering role.
A strong understanding of manufacturing process controls, root cause analysis, and risk management is essential, as well as hands-on experience with process validation, equipment qualification, and documentation within a regulated environment.