Manufacturing Engineer

Manufacturing Process Engineer

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.