Empowering people, creating technology.
Responsibilities:
Duties/Accountabilities (incl. Deputation):
Job Summary: The Process Assembly Engineer is responsible for ensuring the smooth operation of production processes, identifying and implementing improvements, and maintaining high-quality standards.
This involves, but is not limited to:
* Problem solving and troubleshooting on non-conforming materials, customer complaints, and incapable processes.
* Ensuring that processes are set up and monitored according to work instructions.
* Mentoring technicians and operators as required to drive improvements.
* Participation in the development of cell layouts, material travel, & handling, and overall work plan to provide effective synchronous lean manufacturing.
* Ensuring that non-conforming product and processes are evaluated and corrected as required in accordance with process controls and production procedures.
* Participation in plant corrective/preventive and continuous process improvement programs.
* Participation in internal quality audit and vendor audit programs.
* Support and participation in new cell developments/layout ensuring production engineering input is provided to R&D/NPI early in product lifecycles.
* Participation in internal validation program and ensuring that all new processes are supported during validation before transfer to production.
* Drive yield improvements across cells using structure A3 Root Cause Analysis methodology.
* Improve output and cell efficiencies using lean tools and methodology.
* Customer management in ensuring that supply of product is maintained, technical issues resolved, and change management effectively planned and controlled ensuring all customer needs met in compliance with VistaMed QMS.
* Identify and implement technical improvements where applicable.
* Adhere to plant safety requirements and health and safety requirements relating to your work, assuming responsibility for those aspects of the OH&S System over which you have control to ensure the health and safety of yourself and others.
* Be aware of the potential environmental impacts associated with your work and the implications of non-conformance.
* Contribute to enhanced energy performance by conservation of energy where possible.
Qualifications:
The minimum criteria for the job candidate are specified.
Required:
* Bachelor's Degree in Polymer Science, Biomedical or Mechanical Engineering.
* 5+ years' experience in a Process Assembly technician role in a medical device environment including clean room manufacture, validations, process controls, process improvements, lean manufacturing etc.
* Students (unqualified) will be assigned to a fully competent individual. Co-signing will be implemented by the student's Manager.
* An Associate position may exist for limited experience and will be assigned to an experienced Engineer.
* A Senior position may exist for a minimum of 4 years' experience.
Desirable:
* Lean Systems Green Belt (LSGB) Certified
* Six Sigma Green Belt (SSGB) Certified