Process Development Engineer
We are seeking a highly skilled Process Development Engineer to join our team at Recruit Island.
The successful candidate will be responsible for managing projects and the identification, specification, introduction, management and validation of new equipment, processes, products and technologies.
This role requires a science-based approach to develop processes, process improvements and technology improvements.
Main Responsibilities:
* Develop and validate new processes including running trials/feasibility studies for new product/product iterations and new technology to demonstrate capability and achieve key project deliverables (Cpk, cycle times, lead-time, GM% etc.)
* Design and implement new methodologies, materials, machines, processes or products to bring concept to market, including essential product and process documentation
* Work with equipment and material vendors to mutually understand their and our technical process challenges, to improve capability and eliminate cost
* Prepare project plans that specify project phases, tasks, task interdependencies, durations, resource assignments, and costs
* Write and review new customer development proposals for development projects
* Lead improvement initiatives as assigned including investigations, trouble shooting, driving effective determination of root cause and championing a structured approach to problem solving using lean tools and 6 sigma principals
* Complete validation plans, FMEAs, validation protocols, validation reports, control plans and test method validations supported with appropriate statistical tools in accordance with quality system and the requirements of ISO13485, The Medical Device Regulation and FDA Quality System Regulations
Skills and Qualifications:
* Degree in a relevant engineering, science or an equivalent discipline
* 3+ year's work experience in industry, Medical device or manufacturing experience is essential
* A practical level-headed individual with strong technical ability
* Ability to work hands-on, with a solid engineering background, engaging cross-functional groups, equipment and material vendors to resolve technical issues
* Project management skills, setting realistic objectives