SUMMARY:
Reporting to a Business Unit Engineering Manager, the Project Engineer will have an excellent understanding of engineering principles, theories, concepts, practices, and techniques.
The Project Engineer will provide manufacturing support, implement process improvement initiatives, and lead projects across a range of product lines.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
1. Provide manufacturing support over a range of manufacturing processes.
2. Lead process improvement initiatives to reduce cost and improve manufacturing efficiency by using data analysis.
3. Manage projects and lead new product introduction projects introducing new processes as appropriate.
4. Carry out process and product validations.
5. Implement product, process, and material changes through validation, change control, and documentation updates.
6. Familiarize yourself with a variety of processes to allow you to work across a number of product lines.
7. Conform to the requirements of the quality and environmental management system.
8. Additional ad hoc duties and projects as assigned.
QUALIFICATIONS AND EXPERIENCE REQUIRED:
1. Level 8 or equivalent Degree in Engineering or similar discipline is desirable.
2. 3 years' experience in a medical device manufacturing engineering role is desirable.
3. Knowledge of medical device validation protocols and associated documentation.
4. Implementation experience of validation protocols.
5. Knowledge of AutoCAD and Solid Works is desirable.
6. Lean and Six Sigma knowledge.
7. Strong process engineering background.
8. New product introduction experience.
9. Strong team player, with the ability to work on own initiative.
10. Guided by the disciplines of due diligence and compliance in all aspects of work.
11. Ability to work with cross-functional teams, including quality, production, and supply chain.
12. Excellent interpersonal skills.
13. Ability to plan, organise, and prioritise own daily work routine to meet established schedule.
14. Good understanding of ISO 9001: 2008 and ISO 13485.
15. Excellent knowledge of MS Office.
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