Cache of job #13818131

Job Title

Manufacturing Engineer

Employer

ICDS Recruitment

Location

Galway

Description

Manufacturing Engineer - County Galway. Job Overview: The Manufacturing Engineer is responsible for performing a variety of technical and support roles to the production / manufacturing department. Key Responsibilities. • 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 troubleshoot 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. Qualifications and Experience Sought: • 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. • Will have 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. • Creative, continually learning and exploring new ideas. • High level of flexibility required with regard to role and prioritisation of activities. • A good team player who works well in a small team environment. • Ability to stay connected to multiple projects simultaneously. This job originally appeared on RecruitIreland.com.

Date Added

2353 days ago

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