Engineering Manager

3 weeks ago


Sydney, Australia Core Talent Full time

02 Feb 2023
- NSW, North Ryde, Sydney, Australia
- Full-time
- + Super
- Engineering

The Business

This Client is a world wide medical device company that has offices based in Europe, Austrilia and U.S. They are looking to add to their dynamic team with a Manufacturing Engineeirng Manager. Built on 10 years of production they are growing on a daily basis.

Responsibilites
- Sustain all production lines and processes in a qualified state, including appropriate equipment selection, installation, maintenance & calibration, validation, documentation and training.
- Ensure the timely and successful transfer and ramp up of products from product development into full production through establishing efficient, stable and repeatable manufacturing processes in collaboration with the product development teams and suppliers.
- Development and implementation of manufacturing and production engineering practices as well as plan, organise, implement, and review engineering structure and activities.
- Manage and review changes in BOMs, system build standards, and ensure correct part numbering and structure accuracy.
- Assist in the analysis and documentation of production requirements for all products.
- Implement and support QA functions
- Ensure process validation and implementation of changes are performed in line with Quality
- Management System and regulatory requirements.
- Ensure high levels of documentation standards are maintained for all documents prepared by
- Manufacturing Engineering team.
- Build, manage and develop a high performing Manufacturing Engineering team who are committed to product quality and improving efficiencies (yields).

**Requirements**:

- A Bachelor's degree or higher in Manufacturing Engineering, Mechanical Engineering, Biomedical Engineering or related discipline
- Formal training in systems, process, or manufacturing engineering
- At least 8 years of experience in a manufacturing engineering environment
- At least 3 years of experience in regulated (FDA, TGA, TUV) environment
- Proven ability to coach, develop, engage and effectively manage the performance of engineering teams
- Working knowledge of regulatory requirements and experience with working in a quality-controlled environment
- Experience in working within Production Management system (e.g., Lean, Six Sigma)
- Ability to produce reports and presentations to a professional standard



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