Position Overview / Purpose:
To maintain efficient and productive production support to the production areas through implementation and management of day-to-day production and process improvements. Provide Engineering support to Production in order that the production targets are met and to implement improvements in the production areas.

Accountabilities:
Accountability 1: Production support
? Provide the first point of contact for production on yield, quality and throughput issues.
? Provide solutions to identified production problems with particular reference to the day-to-day running of the line.
? Analyse production rejects as required to reclaim where possible, identify, and rectify root causes of rejects.
? Ensure MRN’s, Concessions and Change Notes are processed in a timely manner.
? Provide reports on activities as requested.
? Create plans to coordinate activities; mentor peer and less senior engineers and technicians (when required) to progress plan

Accountability 2: Project Work
? Identify and understand requirements.
? Identify process solutions to meet requirements
? Create plans to coordinate activities and mentoring other engineers and technicians when required to progress plan.
? Execute projects to maximise production efficiencies on existing production processes to include the selection of appropriate equipment.
? Execute projects to review and improve production “indirect” processes e.g. paperwork, bar-coding etc.
? Create appropriate process documentation which ensures:
o Minimal iterations are required
o Good manufacturability
o Process validation is passed

Accountability 3: Point of contact for other departments
? Assist the maintenance and calibration group where necessary to ensure timely repair and calibration of equipment.
? Liaise with other appropriate support groups (e.g. D&D, Procurement) to resolve issues e.g. Manufacturability.
? Monitor progress of improvement plans and provide feedback to interested parties.
? Communicate clearly and concisely verbally and in writing
? Interact with staff in other departments
? Interact with outside suppliers

Accountability 4: Compliance to regulations
? Work with production and engineering to ensure work instructions result in the manufacture of compliant product.
? Ensure that Good Manufacturing Practice (GMP) is followed.
? Ensure all documentation is to quality system.
? Prepare V&V Plans
? Prepare V&V Protocols and Reports
? Ensure safety and efficacy of devices through rigorous testing.

Accountability 5: Strategic improvement
? Assist in the development of strategic improvements for production including factory layout.
? Review product, process and equipment designs from other departments to ensure they meet production requirements with regard to execution time, maintainability, OH&S, reliability and are adequately documented.

Accountability 6: OHS
? Immediately reporting all incidents, accidents, hazards or unsafe work conditions to management
? Participation in incident investigations as required
? Understanding the company’s emergency evacuation procedures
? Performing all work duties in a manner that ensures the health and safety of all employees
Key Incumbent requirements:

? Tertiary qualifications in Engineering. Prefer Mechanical, Manufacturing, Aeronautical, Biomedical or Mechatronics.
? 10 years+ experience in a similar production role within a highly regulated industry
? Experience in working within a Quality Management system
? Experience in working within Production Management system (e.g. LEAN)
? Proven competencies in problem solving, design, manufacturing / business process development and personal influence

Ideal
? Experience with project management tools
? Medical device industry experience and an understanding of GMP
? Process knowledge and experience