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Posted 115 months ago

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Sr Engineer, Process Development

Sunrise, FL, United StatesRemoteFull-time

AI Summary

Sr Engineer, Process Development designs, evaluates, and implements manufacturing processes for aortic stent grafts, leads design transfer and validation, and scales processes from small-scale to commercial production.

About this role

Sr Engineer, Process Development

Open Scientific provides contract staffing and direct hire recruitment services for the scientific, engineering, laboratory and manufacturing sectors.

Position Summary

Determine operations to product products and develop processes to ensure quality, cost and efficiency requirements. Lead and manage key process items to bring new products through the design phase into efficient manufacturing operations.

Key Accountabilities:

·Design, evaluate, implement and monitor processes and operating systems for the manufacture aortic stent grafts

·Develop and implement new mfg processes, execute process validations such as IQ, OQ, PQ protocols and reports

·Lead the design transfer phase including product development, validation planning, design for manufacturability and assembly, Design of Experiments, process capability analysis, etc.

·Conduct risk analysis including DFMEA, PFMEA and create/maintain necessary documentation.

·Support the conversion of small-scale processes into commercially viable large-scale operations.

·Monitor and improve the efficiency, output and safety of manufacturing processes through observations and measurements as well as by collecting and interpreting data from other technical and operating personnel.

·Other various responsibilities and projects, as necessary

Minimum Skills and Capabilities:

Minimum Knowledge & Experience required for the position:

Travel requirements: Minimal

Additional Information

All your information will be kept confidential according to EEO guidelines.

Skills

Aortic Stent GraftsDesign Of ExperimentsDFMEAIQ OQ PQ ProtocolsManufacturing Scale-upPFMEAProcess Capability AnalysisProcess Validation

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