This person will be the Lead Manufacturing Representative for the Medical Device department onsite. This role is specifically for a new project to support a Global MedTech company with an exciting new product. It will also be responsible for supporting and coordinating the activities of a small manufacturing cell.
- Set up a new Manufacturing Process.
- Clean Room manufacturing process set up.
- Manage the successful scale up and commercialisation of this new process ensuring that target yield, capacity, throughput time and productivity are achieved.
- Design, procure and construct production lines considering flow optimisation, throughput time, product movement, layout and space.
- Set up Preventive Maintenance and Calibration routines.
- Lead the knowledge transfer of this new manufacturing process and provide training to product builders and technicians.
- Provide ongoing day to day support to Production; continually seek to drive improvement in operation performance while also maintaining highest levels of regulatory conformance. Effectively trouble shoot issues implementing “robust permanent fix” solutions.
- Establish and maintain appropriate Manufacturing documentation including, Equipment documentation, pFMEAs, Bills of Materials, Part Numbers, Manufacturing procedures and Logs.
- Support setting up of Product, Component ordering, Consumables, and Material necessary for validation and production.
- Draft IQ/OQ/PQ protocols. Develop and execute required validations in line with regulatory requirements to include Equipment, Process & Product validations.
- Demonstrated expertise and detailed knowledge of the medical device industry.
- Experienced in Product Transfers and Manufacturing process set-up and scale-up.
- Equipment Procurement and Validation experience.
- Proven technical expertise and competence across all aspects of Manufacturing Engineering function including lean.
- Has prepared SOPs, conducted IQ/OQ/PQs and/or validations previously in a regulated environment.
- Understanding of working within ISO 13485 environment.