My client, a Leader in automated manufacturing services, are looking to hire a Process Engineer. Your new role will give you the opportunity to work in the area of Medical devices, automation and new product introduction.
- Developing project charters, plans, schedules and implementing plans associated with, but not limited to, cost reduction, waste reduction, increased throughput and general operational improvement through the use of Six Sigma statistical methods.
- Design and specification of equipment and systems to current regulations and design standards.
- Determining and justifying capital projects. Specification of new equipment and components by working with capital project team to complete and route through a Corporate stage gate system.
- Writing, conducting, analysing, determining and reporting on new or modified equipment capabilities, qualifications (IQ/OQ/PQ), and validations.
- Support validation assessment and validation execution for Clean, Automated and Packaging processes.
- Assist in SAT/FAT as required.
- Troubleshooting daily production and process problems, communicating with plant management team, supervisors and operators regarding run problems, investigates root causes, recommends and implements corrective actions.
- Competent working knowledge of automation.
- Competent knowledge of the medical device industry and of 21 CFR, (820, 11), ISO13485
- Competent to effectively communicate manufacturing plans, proposals, results and negotiate options at management levels.
- Excellent report writing, analytical and problem solving skills as well as understanding of root cause analysis methods.
- Skilled user of engineering tools and software packages to design and automate manufacturing processes i.e. AutoCAD, SOLIDWORKS.
- Skilled in writing and execution of Validation protocols, IQ/OQ/PQ, FAT, SAT, CAPA, FMEA, SOP’s, Control Plans
- 5+ years’ manufacturing experience.
- Automation AND/OR Medical devise experience desirable.
- B.Sc. in Mechanical, Industrial or other Engineering Science and demonstrated multiple years of Validation experience
- Requirement for ISO13485 Medical Device and Automation experience
- Handling project assignments of large scope and complexity and able to prioritize and complete work in a timely manner.
For a confidential discussion and more information on the role please contact Christopher O Toole.