Responsibilities:

Evaluate and develop manufacturing processes, design and conduct research programs; apply knowledge of product design, fabrication, assembly, tooling and materials; conferring with equipment vendors; soliciting observations from operators. Responsible for manufacturing process of high-pressure catheter balloons using pleat and fold processes, testing via vacuum leak and high-pressure testing. Responsible for installation and qualification of all manufacturing equipment including injection molding equipment and balloon catheter pleat/fold equipment. Plan, document and execute process development and process validations including IQ/OQ/PQ, drafting protocol/reports, risk management (PFMEA), and statistical data analysis. Improve manufacturing efficiency by analyzing and planning workflow, space requirements and equipment layouts using statistical methods. Design and implement manufacturing fixtures and equipment. Support Manufacturing Supervisor by providing manufacturing decision-making information; calculating production, labor and material costs; reviews production schedules; estimates future requirements.

Requirements:

Bachelor's degree in Biomedical, Mechanical or Industrial engineering, or equivalent, plus. 5+ years of experience as a Manufacturing Process Engineer, preferably in Medical Devices. Experience using statistical analysis methods for process development and control, Minitab experience preferred. Proven experience in chemical and process engineering. Working knowledge of process engineering software such as SolidWork. Experience in Lean Manufacturing Six Sigma certification. Experience in

ISO 13485/ISO 9000. IQ/OQ/PQ

experience.