About the company/role: Our client is a leader in the field of medical devices specializing in infection prevention. The Lead NPI Engineer will be responsible for process development and validation within the NPI function.
Responsibilities include:- Lead and manage NPI Engineering work-packages in the process development and validation space Coordination of NPI resources and train staff
- Mentor NPI engineers in process development and validation
- Work closely with the R&D team to ensure product functional and performance requirements are clear
- Develop and maintain detailed COGS modelling for assigned products & facilitate and input into strategic sourcing decisions.
- Develop manufacturing processes (environment, facilities, equipment, tools, test methods, work instructions)
- Conduct process validation and verification
- Development and establishment of BOM and routing
- Provide design for manufacture (DFM) & design for inspection (DFI) feedback to the cross-functional design team
- Develop & embed supporting processes to ensure standardisation of approach
- Identify design and process issues, identify root cause, and implement solutions
- Identify, develop and implement continuous improvement initiatives
Skills & Experience:- Degree in Engineering required
- Extensive experience in the medical device or pharmaceutical industry
- Previous experience in leading engineers
- Demonstrated experience in process validation and development - design of validations from first principles for new products or technologies.
- Excellent written and verbal communication skills
Apply!If you think this could be the role for you, then please apply now! Please send us a cover letter AND a detailed resume in WORD format (PDFs can be corrupted / not processed). Or, if you have any questions, please contact Nikita on 02 8071 4290.
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