- Demonstrates basic technical expertise on process/product technologies to support design, optimisation, validation and troubleshooting of those technologies.
- Under supervisory direction, provides input to Equipment engineering or external equipment/tooling or material vendors in the selection, design & development of new (or upgrades to existing) equipment, tooling and materials.
- Demonstrates good working knowledge of DFSS/DMAIC tools and, with mentor assistance, applies these tools in the characterization, optimization and troubleshoooting of process equipment and technology performance.
- Supports the development and execution of experimentation and testing to enable characterisation, optimization and troubleshooting of processes and equipment. and summarises, analyses and draws conclusions from test results leading to effective technical resolution.
- Supports 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.
- With mentor assistance demonstrates good working knowledge and application of Lean methodologies, and process improvement tools to assist in identification and elimination of “waste” process steps and development of efficient, cost effective equipment and processes.
- With mentor assistance demonstrates good working knowledge and application of Process and equipment validation techniques, PFMEA’s, and associated regulatory requirements and applies this knowledge in the support of efficient & timely validation of equipment and processes.
- Under supervision supports the writing and release of process validation documentation including FMEA’s, Validation Plans, protocols and reports.
- Under supervision, supports execution and documentation of validation builds, co-ordinates testing of validation units and compiles, analyses and reports on the validation results.
- With mentor assistance ensures compliance with all the regulations governing the quality systems.
- Level 8 honours degree in a relevant field.
- 2+ years of experience in Medical Devices would be desirable.
The successful candidate must be a self-starter with the ability to work on own initiative, while possessing strong team player characteristics.