Job Description
Our client, a Medtech company based in Galway, now seeks a Process Engineer to develop robust, capable, cost effective & safe manufacturing processes, equipment, materials and products and will support efficient and effective transfer of new products & processes into commercial manufacture.
The successful candidate will work with R&D, Manufacturing and Equipment Engineering, pus external equipment/tooling and material vendors in the selection, design & development of new (or upgrades to existing) equipment, tooling and materials for NPD and NPI.
The ideal candidate will be experienced in new product development and manufacturing experience in high-tech industries; who is experienced in process and equipment validations, PRAs, and comply with associated regulatory requirements.
Responsibilities for Process Engineer, NPI:
Leads the development and execution of experimentation and testing to enable characterisation, optimization and troubleshooting of key processes and equipment.
Drive continuous improvement focus, applies lean or six sigma tools in the characterization, optimization and troubleshooting of process equipment and technology performance.
Leads Technicians, managing their technical development and facilitating their daily and project tasks.
Lead lean and process improvement tools in the elimination of "waste" process steps and development of efficient, cost effective equipment and processes.
Lead the introduction of new processes, equipment and materials including installation, calibration, EHS assessment debug, and all associated process and quality system documentation requirements including technical and process work instructions.
Completes or leads the writing and release of process validation documentation including FMEA's, Validation Plans, protocols and reports.
Requirements for Process Engineer, NPI:
Honours Degree (HETAC Level 8) in Engineering or Science.
4+ years post graduate experience in new product development and/or manufacturing experience in high-tech industries.
Ideally Project Management experience.
Strong data-analysis and process methodology expertise in process engineering role.
Proven experience in working in cross-functional project teams.
Proven experience in process and equipment validation techniques, PFMEA’s, and associated regulatory requirements and application to validation of equipment and processes.
Travel to other sites / vendors as part of Technology development & transfer activities.
Please contact Larry on 01-2302400 / larry@rftgroup.ie / http://www.rftgroup.ie/
The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors. www.rftgroup.ie
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