Process Engineer Resume Laguna Niguel, CA - Hire IT People

SUMMARY

To obtain a challenging Engineer position utilizing my manufacturing, process development, analytical, and communication skills.
Medical Device Experience: Utilizing analytical and organizational skills to develop product and manufacturing process to meet customer requirements and optimize production yield.
Experience wif Commercial line - readiness and line validation, new product development and production readiness, and project management.
Computer Skills: Design: AutoCAD, Solidworks, and Pro/E. Data analysis in Minitab.

PROFESSIONAL EXPERIENCE

Process Engineer

Confidential, Laguna Niguel, CA

Responsibilities:

Develop customized medical balloons wif different specifications, requirements, and materials:
Support high-profile customers for product development, process validation, and high-volume production for product launch.
Develop balloons wif diameter from 2mm to 30mm, and length from 10mm to 300mm for different applications.
Develop balloons wif different materials: Vestimad, Grilamid, Pebax, PET, and Polyurethane.
Validate balloon forming process (OQ/PQ) and utilize Minitab for statistical analysis to ensure process capability.
Provide support as balloon development subject matter expert in resolving Nonconformance Reports (NCR), Customer Complaints, and CAPA utilizing Root Cause Analysis tools: 6M Method, Design of Experiments (DOE), and Fishbone diagram.
Collaborate wif extrusion team on improving tubing performance for balloon development.
Project management experience in coordinating wif customer, supply chain, sales, and suppliers on resolving technical issues, scheduling, prioritizing tasks, assist quoting new development, and working wif suppliers on improving material quality.
Conduct design review and create necessary Engineering Change, Temporary Deviation Notice, Inspection procedures, and complete Design History File (DHF) to ensure production readiness.
Manage in purchasing new equipment for catheter project including quotes, material selection, cost analysis, and tooling design.
Create and execute Installation Qualification (IQ) document, calibration procedure, Equipment Operating Procedure (EOP), and Preventive Maintenance (PM) document for new equipment.
Develop new processes on catheter assembly: laser marking, stent crimping, pad printing, and hole-punching.
Implement Lean Manufacturing activities by introducing 5S practice and Kanban system at work environment.

Manufacturing Engineer

Confidential, Temecula, CA

Responsibilities:

Teh following responsibilities contributes to teh commercial launch of a new Drug-eluting stent (DES) catheter:
Provided training for 75 operators on new production lines.
Supported lines wif 90%+ yield consistently.
Supported commercial line-readiness on equipment, tools, documents, and confirmation study on equipment and process.
Performed line validation protocol and validation report, and conform wif quality requirement per ISO13485.
Optimized manufacturing performance utilizing analytical skills and analytical tools (Root-cause analysis, A3, 6M, Fish-Bone diagram, Design-of-Experiments) to troubleshooting process, material, and procedural related problems.
Evaluated operators' suggestion in manufacturing process and provided necessary document or process change.
Performed NCMR investigation for non-conformance and executed immediate corrections.

Sustaining Engineer

Confidential, Hemet, CA

Responsibilities:

Optimized Production processes wif vendor, R&D department, and Manufacturing personnel.
Managed inventory by creating new part numbers, Bill of Materials (BOM), Routing, and Product Configurator wif JD Edwards.

Mechanical Engineer

Confidential, Placentia, CA

Responsibilities:

Designed mechanical enclosure and electrical parts in customized LCD displays for manufacturing and assembling.
Prepared product specification, drawings, Bill Of Materials (BOM), and quoting and purchasing documentation.

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Process Engineer Resume

Laguna Niguel, CA

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