- Reference: GJ43527
- Job Type: Contract
- Location: Galway
- Category: Engineering, Technical & Manufacturing
As Project Leader you will project-manage and support all aspects of new product/process transfers from R&D in to manufacturing. Reporting to the Operations Manager, you will lead/co-ordinate activities such as process characterization, process validation and process development activities associated with new product/process transfers. New product and process introductions an come from R&D at facility in Japan and from within the company.
- To effectively lead the project management of new product/process transfers from R&D to Manufacturing.
- To deliver projects to agreed standards and objectives.
- To liaise where necessary with Product R&D ( Japan, USA, etc ) during the development of new products.
- To liaise where neceassary with the Automation group during the development of new equipment in order to ensure input is provided on manufacturing related factors such as, throughput requirements, ergonomics, preventative maintenance, calibration.
- To advance process development and process characterization activities using DOE techniques to ensure robust operating process parameters are established and a strong understanding of the equipment capabilities is gained
- To support the development of risk assessments (PFMEA’s) early in the equipment development cycle to ensure all potential risks are identified.
- To support process validation (IQ, OQ, PQ) associated with the new process/equipment introductions.
- Work with the Automation group to ensure equipment drawings, manuals, spare parts, etc. are in place and controlled under Quality System change control procedures
- To work with manufacturing Engineers/ Technicians to ensure transfer of knowledge from the Automation group for all new equipment.
- To evaluate current equipment/processes for sources of variation and sub-optimal capability and implement adequate process controls.
- To identify and implement process related continuous improvement activities to improve product quality and increase Overall Equipment Effectiveness.
- To demonstrate strong leadership and a clear identifiable work ethos within the team.
- To engage with the appropriate personnel in the identification and resolution of Corrective/Preventative actions to address Quality, Technical, and Manufacturing issues (Audit Actions, NCR’s, CAPA’s, etc.).
- To act in a responsible manner regarding Environment, Health & Safety.
Skills, Experience, Qualifications:
- Degree in Mechanical Engineering /Manufacturing Engineering.
- IPMI Certified Project Management Diploma
- 5 years Experience in a medical device industry for manual and semi-automatic processes.
- 10 years Experience with equipment transfer/introduction and/or NPI.
- Process development and process characterization experience utilizing statistical techniques including DOE.
- Process validation experience (IQ/OQ/PQ etc.)
- Experience in process/equipment risk assessments using Risk Management tools such as PFMEA.
- Lean/Six Sigma experience. Data driven analysis with emphasis on statistical techniques.
- Self-confident with drive to identify process and equipment issues and implement robust solutions in a timely manner.
- Excellent analytical and problem solving skills, root cause analysis and risk assessments with a strong attention to detail.
- Ability to work on own initiative.
- Good interpersonal and communication skills with proven leadership abilities.
For a confidential discussion and more information on the role/company please contact christopher.otoole on 091-706713 or email email@example.com
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