Project Process Engineer

CPL

MAYO

RESPONSIBILITIES & DUTIES. Participate or liaise with the core team in evaluation of product concepts to determine potential manufacturing processes. Review proposed product designs for manufacturing. Work with equipment vendors to develop PoP equipment and process solutions. Lead manufacturing process evaluation and selection with reference to current manufacturing strategy and processes. Analysis of manufacturing cost and development of plan to achieve targeted gross margin. Development of User Requirements Specification to validation of processes for all required manufacturing equipment. Development and management of project schedules for manufacturing commercialization of selected product concept. Engagement of other Operations functions in critical decisions and developments. QUALIFICATIONS: Academic/Credentials/Certifications: Primary Degree in Engineering discipline (Mechanical/Manufacturing. Required experience: Minimum of 3 years post qualification experience in high speed manufacturing environment (ideally medical device), to include extensive experience with development, evaluation and validation of manufacturing processes. Experience in New Product Commercialization or New Product introduction and Gate stage processes is a distinct advantage. Proven track record in Design of Experiments and Proof of Principle concept testing and execution preferably within a regulated environment. Specialized skills/technical knowledge: Excel in Project Management skills. Application of DFM and DFx. Ability to Risk assess, DFMEA & PFMEA. Implementation of Lean/Sig Sigma (Mini Tab. Familiarity with process characterization & DoE techniques. Good working knowledge of statistical analysis tools. Expert in Problem solving.

1437 days ago