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Senior Equipment Engineer, Operations Resume

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Fremont, CaliforniA

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SUMMARY:

  • 2 years of Project Management for production line duplication of medical devices.
  • 2 years of Equipment and Automated Systems - E&AS Development Stage Phases & Deliverables for medical devices.
  • 4 years of process engineering in biotechnology / life sciences for New Product Introduction - NPI / product development and back-end manufacturing.
  • 9+ years of combined mechanical design engineering in leak / flow test systems, sealed - vacuum design, semiconductor packaging, micro fuel cells, and medical devices.
  • Expert in mechanical design for intricate high precision tooling to a complete mechanical automation system including sheet metal design for enclosures and mechanical parts.
  • Expert in 3D and 2D CAD for mechanical design and ASME Y14.5-2009 standard GD&T drafting with an understanding of Design for Manufacturability - DFM and Design for Assembly - DFA.
  • Proficient in ISO 9001 and ISO 13485 on medical devices documentation - CR / ECO / ECN / CRB / Deviation / standard operating procedures / maintenance procedures / tool release to production and continuous process / tool improvements.
  • Proficient with a nano-liter liquid handling automation to refine and troubleshoot production processes. Also, established a documentation on tool qualification procedures, improved dispense recipes, operating procedures, troubleshoot guideline, tool release requirements, parts / maintenance procedures.
  • Various experiences of manufacturing processes: substrate singulation / dicing, water jet cutting, injection molding, UV adhesive dispense, UV curing, Plasma treatment, labeling, bagging, packaging, part assembling, QC testing, liquid handling automation, washing / cleaning.

TECHNICAL SKILLS:

  • SolidWorks CAD
  • Siemens Unigraphics UG NX CAD
  • AutoCAD
  • SolidWorks PDM
  • Winchill PDM
  • Agile PLM
  • EVT, DVT, PVT, DQ, IQ, OQ, PQ
  • Design of Experiments - DOE
  • Transfer Manufacturing
  • Contract Manufacturing - CM Project Management
  • Statistical Process Control - SPC
  • Non-Conformance Report - NCR
  • Supplier Corrective Action Report - SCAR
  • Good Manufacturing Practices - GMP
  • MES - Manufacturing Execution System
  • MAS 90 / 200 Accounting ERP

EXPERIENCE:

Confidential, Fremont, California

Senior Equipment Engineer, Operations

Responsibilities:

  • Increased Imaging Catheter production capacity by 30% from duplicating complete production lines.
  • Proficient in Project Management of initiating, planning & budgeting, executing - procurement, construction, installation, validation -, monitoring & controlling, closing.
  • Supported BSC Costa Rica to duplicate / setup a complete catheter manufacturing operation.
  • Led a cross functional team for a Capacity Project to duplicate production line equipment. This effort increased Imaging Catheter production capacity by 25%.
  • Designed, built, and validated tooling, fixtures, and equipment for new applications / process improvements of the production line.
  • Expert in Development Stage Phases & Deliverables of Equipment and Automated Systems - E&AS for Planning & Specification, Design & Construction, Installation & Testing.
  • Project example: Released Automated Plasma Treatment Equipment to reinforce adhesive bonding.

Confidential, Mountain View, California

Mechanical / Process Engineer

Responsibilities:

  • Team lead of back-end manufacturing operations for planar and sipper LabChips, Kinase Assay Kits, and various test chips.
  • Sustained and improved manufacturing processes of LabChips and liquid handling automation.
  • Designed, built, and validated tooling, fixtures, and equipment for process improvements of the production line.
  • Completed New Product Introduction - NPI, qualified and implemented new fixtures / process of the production line.
  • NPI example: Released production line for Fluorescence Calibration Chip.

Confidential, Livermore, California

Mechanical Engineer

Responsibilities:

  • Supported a cross functional team to design, build, and improve fuel cell components and integrated systems.

Confidential, Morgan Hill, California

Mechanical and Design Engineer

Responsibilities:

  • Designed and developed sub-assemblies of singulation automation systems to create a solution for machine design needs.
  • Designed complex custom high precision nest jig tooling for Confidential - BGA chips singulation / dicing.
  • Created system configuration build for singulation automation systems.
  • Diversified as a Sustaining Engineer to resolve issues directly related to production line or customers.
  • Example of issues: Eliminated corner strand/hair-like excess on dicing Intel's Chip On Film - COF / Tape Carrier Package - TCP Confidential - BGA chips.
  • Designed manual or fully automated leak test systems - sealed or vacuum including mechanical design, electrical and pneumatic layouts, and custom elastomer seals for various industries - automotive, medical, fire safety, etc.
  • Managed equipment construction including suppliers’ selection, parts selection and machining, and assembly.

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