The successful candidate will have a proven track record of a performing complex technical work such as the design, manufacture and operation of structures, machines and systems under broad supervision and guidelines. Strong Problem Solving, Lean and Continuous Improvement knowledge and experience. Take a lead role in developing and implementing improvements in production.
- Can initiate own workload and ensures it is aligned to department and site goals.
- Leads complex projects with cross functional team.
- Continually assessing and reviewing day to day manufacturing issues / practises, consistently striving for improvement by analysing, developing and implementing manufacturing techniques and materials to provide robust improvements in compliance with FDA and regulatory requirements.
- Can prioritise issues as they arise.
- Completes technically challenging tasks and identifies appropriate resources when applicable.
- Uses established problem solving techniques to address challenging problems in production.
- Can compile and report KPI metrics for management review.
- Can effectively communicate line issues and offer solutions.
- Generates ECOs, protocols and prototypes under minimum direction.
- May supervise the work of others.
- Ensures all products and processes are developed in compliance with regulatory requirements.
- Performs other related duties and tasks as required.
- Educational experience of a Bachelor’s Degree in Engineering or technical field related to the department of assignment or industry with five years previous related experience, a Master’s Degree with three years previous related experience, or a Ph.D. A minimum of a Bachelor’s Degree is required for this position.
- Ability to apply analytical skills and scientific technical principles in problem solving and development.
- Demonstrated computer skills preferably spreadsheets, word processing, database and other applicable software programs
- Strong interpersonal and organizational skills and the ability to work effectively as a team member.
- Good working knowledge of medical device materials and processes.
- Knowledge of extrusion and chemical processing is an advantage.
- Experience dealing with Marketing, Clinical and Regulatory personnel and enhancing feedback to device concepts.
- Demonstrated analytical problem solving abilities.
- Good working knowledge of medical device quality & regulatory systems and medical device directives.
- Demonstrated experience of applying Lean tools / Six Sigma techniques to improve business processes & performance with good working knowledge of applying 5S and TPM programs. Green Belt or Black Belt certification an advantage.
- Experience in packaging would be an advantage but not required