Senior Manufacturing Engineer

Summary 

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.

Responsibilities 

  • 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.

Requirements 

  • 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.

 

 

+ Apply

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