Descrição da vaga
Manufacturing Engineer – Experienced Manufacturing Engineer required for leading multinational medical device manufacture in the west of Ireland.
- 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.
- 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.