Manufacturing Engineering Manager

**New South Wales - Sydney**

**Not Specified**

**Permanent**

Manufacturing
- Job Reference
- 266980/001

**Manufacturing Engineering Manager**

***

**Sydney**

**Salary negotiable**

**Permanent, full time**

Cutting-edge, Australian-based medical device company, based in Sydney, is looking for a Manufacturing Engineering Manager to join the team, working on pioneering devices. This is a unique opportunity to work for one of the most innovative and progressive companies in Australia and to make a genuine impact on patient care.

**About the Company**

A global medical device company with offices in Europe, Australia and the U.S, which is transforming the industry through a portfolio of therapies, driven by ground-breaking technologies. Their culture is collaborative, with a commitment to disrupting the market via innovation, people and technology.

**Role and **Responsibilities**

Your role will be to support all production areas, through implementation of day-to-day production and process improvements, as well as supporting production operations with engineering and technical services, to ensure manufacturing objectives are met on time, within budget and in a safe, quality-controlled environment.

Your responsibilities will include:

- Establish and sustain production lines and processes - selecting appropriate equipment, testing, installation, maintenance, calibration, validation, documentation and operator training
- Ensure the timely and successful transfer and ramp up of products from product development into full production
- Develop and implement manufacturing and production engineering practices as well as plan, organise, implement, and review engineering structure and activities
- Assist in the analysis and documentation of production requirements for products
- Implement and support QA functions
- Ensure process validation and implementation of changes are performed in line with the QMS and regulatory requirements
- Build, manage and develop a high performing Manufacturing Engineering team
- Look for process improvement opportunities
- Support manufacturing and supply chain operations
- Establish and improve standard operating procedures (SOP's) and DMRs
- Lead the development, implementation and sustaining of a total asset management (TAM) program
- Promote communication, respect, teamwork, performance and professionalism
- Identify and recommend technical training requirements for the team

**Your Skills and Experience**

You will have a bachelor's degree or higher in Manufacturing Engineering, Mechanical Engineering, Biomedical Engineering or related discipline, plus:

- Formal training in systems, process, or manufacturing engineering
- At least 6 years of experience in a manufacturing engineering environment
- Experience in a regulated (FDA, TGA, TUV) environment - desirable
- Experience in a formal quality assured environment such as ISO 9001 or ISO 13485
- Experience in medical device design and development - desirable
- Experience in working within Production Management system (e.g. Lean, Six Sigma)
- Ability to produce reports & presentations to a professional standard
- Proven competencies in problem solving, decision making, design transfer, manufacturing / business process development and personal influence
- Experience in engineering people resource management

**Benefits**
- Work with talented colleagues who are passionate about innovation and transforming patient lives
- High tech, creative and collaborative environment

**N.B. You must hold full, unrestricted and ongoing rights to work in Australia to be eligible for this role and be fully vaccinated against Covid-19.