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Process Development Engineer

Reference:JCACDY-252105
Location: Dublin
Qualification:Degree
Experience:3-4 Years
Job Type:Permanent
Salary:Not Disclosed
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Process Development Engineer

In support of its ongoing medical device development programme, our client currently requires a Process Development Engineer, to support product and process development activities

Role/Responsibilities

• Development of Class III medical devices and associated manufacturing processes, entailing:
o Device development based on outputs from product/process improvement feedback
o Process development to facilitate manufacture of product, including implementing appropriate process controls
o Development and validation of test and inspection methods
o Requalification of devices and processes to support change implementation
o Training of operators on developed processes
• Development of project documentation, with focus on detail and quality
o Product specifications
o Detailed product/tooling drawings
• Generation and maintenance of manufacturing documentation (Manufacturing strategies, Process Flows, DMR, DHR)
• Development and updates of Risk Management documentation through entire product lifecycle
• Planning and execution of verification and validation activities, including
o Procurement of capital equipment
o Assisting in the generation of Validation Master Plans
o Generating verification / validation protocols and reports
o Execution of Equipment Validations (IQs/OQs) and subsequently Design Verification and Process Validation (OQ / PQs)
• Assist in managing vendor quality and providing technical support
• Support Regulatory Affairs with submissions

Skills/Experience:

• Third level degree in Mechanical, Manufacturing or Production Eng or similar discipline
• Min. 3 years experience in product / process development, ideally in Class II / III medical devices
• Design Skills involving 3D modelling
• Experience designing jigs and fixtures and developing automated processes
• Knowledge of materials and processing techniques (polymers, metals, ceramics), including rapid prototyping
• Knowledge of manufacturing processes within a clean-room environment
• Attention to detail and Quality Focus
• Strong communication skills



James Cassidy | Tel: +353 (0) 1 5079250





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