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Manufacturing Engineer
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Engineer, Manufacturing
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Manufacturing Engineer - Hopkins, United States - Katalyst HealthCares & Life Sciences
Description
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.
Plan, document and execute process development and process validations including IQ/OQ/PQ, drafting protocol/reports, risk management (PFMEA), and statistical data analysis.
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.
Requiremnets:
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.
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