The Manufacturing Engineer is responsible for performing a variety of technical and support roles to the production / manufacturing department.
• 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.
Competencies and Attributes
• Demonstrates 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.
Clodagh Nerney | Tel: +353 (0) 1 507 9254