Process Engineer II

Responsible for providing mechanical engineering support in the creation and the development of new medical device products (invasive and non-invasive). Researches, develops, designs, and evaluates mechanical and electro-mechanical materials, components, assemblies, processes and/or equipment. Conducts feasibility studies to verify capability and functionality. Develops new concepts from initial design to market release. Maintains detailed documentation throughout all phases of development. Working as part of the Process Development group this person will aid design of new equipment for new products & manufacturing. Applies technical knowledge to innovate, design, and develop processes, procedures, tooling and/or automation. Executes the functional deliverables associated with the PDP/TDP and Quality Systems. Plans, organizes, and conducts all aspects of technical reviews. Ensures proper documentation is completed to meet quality systems requirements. (e.g., BOM's,FMEA's, etc.). Reviews or coordinates vendor activities to support development. Demonstrates knowledge and application of Lean methodologies, and process improvement tools in identification and elimination of "waste" process steps and development of efficient, cost effective equipment and processes. Demonstrates knowledge and application of Process and equipment validation techniques (IQ, OQ, PQ), FMEA, and associated regulatory requirements and applies this knowledge in the efficient & timely validation of equipment and processes. Co-ordinates execution and documentation of validation builds, co-ordinates testing of validation units and the compilation, analysis and reporting of the validation results. Demonstrates a primary commitment to patient safety and product quality. Understands and complies with all the regulations governing the quality systems. Hons bachelors degree engineering degree qualification 3+ yrs engineering experience in a GMP environment