This is an exciting opportunity to gain excellent medical device experience in a new company that has recently been acquired.The Manufacturing Engineer is responsible for performing a variety of technical and support roles to the production / manufacturing department. Ideallyyou will have experience in drug coatings or medical device experience.
THere are approximately 70 people in the company and that number is to increase over the next 5 years.
This role involves working on 2 very high value projects. They need someone who can understand quality systems, how you setup a process. You will ideally have worked on the line and has made enhancements to the process aswell as process design and validation experience
- Set up a new Manufacturing Process.
- 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 “Lean” production lines taking into account flow optimisation, throughput time, product movement, layout and space.
- Specification, Procurement, Installation, and Validation of Manufacturing Equipment. This will include on site Factory Acceptance Testing of equipment.
- 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, TMVs, Bills of Materials, Part Numbers, Product routings, Manufacturing procedures and Logs.
- Set up and order Product, Components, 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.
- Generate and gain approval for project budgets and subsequently manage expense and capital expenditure in line with this budget.
- Partner with R&D, Quality and Operations to ensure that the transition of products through R&D, product approval and manufacturing scale up are smooth, timely and cost effective
- Engineering Degree or equivalent.
- A minimum of 3 years’ experience in a similar role
- Strong technical understanding of set up and maintenance of manufacturing processes, experience in validation, equipment design and Lean Manufacturing highly desirable.
Please contact Fiona Keane at 091 507 502 or 086 0279952 if you would like more information
- Demonstrated expertise and detailed knowledge of the medical device industry and in particular combination medical devices. Familiarity with Drug and other Coating techniques.
- 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.
- Effective knowledge of the regulatory environment in which the business operates.
- Proven written and oral communication skills and an ability to prepare competent business cases.
- An analytical approach to problem solving.
- Oral communication skills and capacity to represent the company to customer and representatives of regulatory bodies.
- Is creative, continually learning and exploring new ideas.
- High level of flexibility required with regard to role and prioritisation of activities
- A self-starter applies his/her own initiative in most situations.
- A good team player who works well in a small team environment.
- Capacity to maintain the highest levels of confidentiality internally and externally.
- Ability to stay connected to multiple projects simultaneously.