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Details
Senior Product/Process Development Engineer
Reference: | JCAO2212 | Location: |
Dublin |
Qualification: | Degree | Experience: | 4-5 Years |
Job Type: | Permanent | Salary: | Not Disclosed |
May be suitable for:
Snr R and D Engineer
Medical Devices – Senior Product/Process Development Engineer
Our client a medical device company who are developing a novel drug delivery system are currently seeking a Senior Engineer to join their team. to support product and process development activities from completion of concept feasibility to commercialisation. This is a great opportunity for an engineer looking to step into Senior Role from Engineer level
Role/Responsibilities:
- · Development of Class III medical devices/processes, including the following o Drive product/process design and development to develop processes and supporting documentation for the neurological product portfolio
- Work on elements of product lifecycle from design verification through to commercialisation o Drive ongoing product and process improvements
- Development and validation of test and inspection methods (TMV/MSA) o Draft and execute equipment and process validation activities
- Applying lean principles, design/develop and introduce manufacturing processes for new products to meet the demands of productivity and quality (considering automation)
- To lead technical investigations and provide resolutions to a variety of technical problems with effective root cause analysis and implementation of effective corrective action
- Development of prototype devices based on outputs from the concept feasibility team
- Maintain high quality and compliance standards in line with the Renishaw QMS
- Generation and maintenance of manufacturing documentation (Manufacturing strategies, Process Flows, pFMEA, DMR, DHR)
- Support Production Builds for both Pre-Clinical and Clinical Trial including process verification activities after submission of clinical trial application.
- Maintain equipment in line with PM schedules
- Generation of IP
- Ensure all Health, Safety and Environmental requirements are fulfilled
Skills/Experience:
- Third level degree in Mechanical, Manufacturing or Production Eng or similar discipline
- Min. 4 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 medical device quality & regulatory systems and medical device directive (ISO13485, MDD and FDA CFR 820).
- Experience of manufacturing processes within a clean-room environment
- Experience of risk assessment, particularly pFMEA
- Attention to detail and Quality Focus
- Strong communication skills Although not essential, it is desirable if applicants have the following: Knowledge of anatomy and physiology
- Experience of Lean manufacturing methodologies, DFM and 6-sigma desirable
- Ability to create new ideas and provide innovative solutions.
For further information please contact [email protected] or call in confidence 086 0204322
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Life Science Recruitment | Tel:+353 1 685 4848 | Fax: +353 (0)1 443 05 24 | Email: [email protected] | Copyright © 2021 Life Science Recruitment Ltd
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