Software Developer/ Engineer/ Architect
Process Development Engineer
- Previous new product development and/or manufacturing experience in medical / pharmaceutical industries a distinct advantage; in particular 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.
- Demonstrates strong technical expertise on process/product technologies to support selection, design, optimisation, validation and troubleshooting of, and can mentor engineers and technicians in problem resolution on, those technologies.
- Continuous improvement focus, demonstrating strong knowledge of Six Sigma methodologies and applies these tools in the characterization, optimization and troubleshooting of process equipment and technology performance
- Demonstrates 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.
- 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.
- 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.
- Bachelors (HETAC level 8) in relevant discipline.
- Minimum of 3 years experience in a medical device or other related environment.
- Proven experience in process improvements.
