Our client, a medical device company in Galway are currently looking to recruit a Senior Process Engineer for their site.
Works cross-functionally to lead the development of robust, capable, cost effective & safe manufacturing processes, equipment, materials and products and ensures efficient and effective transfer of new products & processes into commercial production.
- Drive innovation & change by providing scientific understanding and technical engineering skills on products/processes to meet business goals and objectives - utilizes strong working knowledge and application of all the regulations governing the quality systems to coach, lead and enhance the productivity of engineering teams. Build collaborative relationships through strong teamwork across the organization.
- Provide strong technical direction on Product & Process issues within IC division. Experience in one or more of the following areas a distinct advantage - Drug Eluting Stents and / or TAVI product & process technologies.
- Experience in New Product Development, including knowledge of the PDP Process and Regulatory submissions.
- Requires a strong, comprehensive product knowledge & understanding; clinical relevance - design ? product specifications ? prints ? test methods ? process development and their impact / linkages.
- Liaises with other relevant functions with regard to ongoing development of current product, processes and systems and future development needs.
- Project planning, in detail, in support of major projects, product/process development & changes ? ability to effectively manage multiple projects in parallel.
- Champion/lead cost reduction efforts (DFM & COG's) demonstrating a strong knowledge and application of Lean methodologies, and process improvement tools in identification and elimination of "waste" process steps and development of efficient, cost effective equipment and processes.
- Continuous improvement focus, facilitates the use of Six Sigma & Problem solving tools among a team of engineers and technicians in the characterization, optimization and troubleshooting of process equipment and technology performance.
- Provides Technical Leadership to Engineers and technicians, in the selection, design, optimisation, validation and troubleshooting, of key processes & product technologies.
- Leads the development and execution of experimentation and testing to enable characterisation, optimization and troubleshooting of key processes and equipment and summarises, analyses and draws conclusions from test results leading to effective technical resolution.
- Requires a strong knowledge of Fixturing/Equipment design and liaises with Equipment Engineering or external equipment/tooling or material vendors in the selection, design & development of new (or upgrades to existing) equipment, tooling and materials.
- Co-ordinates 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.
- Demonstrates strong knowledge and application of Process and equipment validation techniques, PFMEA?s, and associated regulatory requirements and applies this knowledge in the efficient & timely validation of equipment and processes.
- Leads the writing and release of process validation documentation including FMEA's, Validation Plans, protocols and reports.
- Leads execution and documentation of validation builds, co-ordinates testing of validation units and the compilation, analysis and reporting of the validation results.
- Supervision of one or more Engineers or Technicians, managing their technical development and facilitating their daily and project tasks.
- Demonstrates a primary commitment to patient safety and product quality.
- Ensures all direct reports are aware of their commitment to patient safety and product quality, are current with their training requirements and that they understand and comply with all other regulations governing their work.
- Understands and complies with all the regulations governing the quality systems.
- Travel to other sites / vendors as part of Technology development & transfer activities.
- Honours Degree - HETAC Level 8
- 5+ years post graduate experience
- 5+ years of demonstrated process development/manufacturing/improvement activities - use of Six Sigma/Lean methodologies, Process Validation
- Demonstrated cross functional teamwork in technically demanding environment
For further information on this Senior Process Engineer role in Galway please contact Deirdre Finnerty on 091730022 / email@example.com
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