SUMMARY:

• Sr. Manufacturing Operations and Engineering Manager with a solid background in Medical Devices, Consumer Electronics, Confidential /Main - frame CEM, Automatic Test Equipment ( Confidential ).
• Natural leadership and business acumen: skilled in Design Control (R&D), CM, Project Management, TQM and Regulatory Compliance in conjunction with New Product Commercialization while ensuring best practices in capacity, budgeting and cGMP.
• Create reliable processes, resulting in recognition for the ability to rapidly improve productivity and profitability.
• An equal blend of business expert and hands-on manufacturing operations & QA Engineering leader who inspires and fosters team commitment, pride, and trust while anticipating and meeting the needs of both internal and external customers.
• Creative, innovative, and forward-thinking; adept at handling complex business development challenges with thoughtful, clearly-defined strategies.
• Technical and project management of outsourcing strategy for FAB/ Confidential and main-frame chassis manufacturing, full integration & testing, contract negotiation, out-of-box quality, SCM (Supply Chain Management) and final integration of electro-mechanical assemblies with world-class contract electronic manufacturers (CEMs), including multiple CEMs in China, Japan, Korea, India and USA.
• Very high proficiency in utilizing design control tools (i.e. FEMA, DOE, Risk-Management, and SPC) and TQM/QMS (i.e. Six Sigma, LEAN, 8D/5S, PDCA/SDCA, Muda, TPM, Zero-Defects, and Kaizen).
• Strong working experience with complex hardware (PCB/ Confidential & Power-System), electro-mechanical mainframe, cable-harness and software (Diagnostics/Calibration/Test-Programs) design & validation testing for Mixed-Signals, VLSI, Power Management, RF, High-Voltage Instruments and Medical Instrument both in R&D and volume production environments.
• Established routine generations of multiple status reports for tracking of KPIs of production first pass-yield, OEE (for capital equipment’s and test-fixtures), on-time shipments, CAPAs, CARs, labor’s efficiencies and utilization factors, in respect to company’s goals and best practices in industry.
• Strong working and academic knowledge of IT Development Environment, ERP/MRP (SAP, Expandable, Epicor, ASK) developments & applications, Requirements Management Tools, CRM (Clarify), PLM (Product Lifecycle Management), Software Development Life-Cycle (SDL) and Scrum.
• Received several Awards throughout career for innovation and job performance.

KEY QUALIFICATIONS / SKILLS:

New Product Commercialization (NPC) Project Management ISO9001 ISO13485 21CFR820 ISO14971 IPC620/610 Agile PLM Agile - Scrum High Volume Manufacturing (HVM) Internal/External Audits ERP/MRP TQM Lean Manufacturing Good Manufacturing Practice (cGMP) Design Control Engineering Change Management process Supply Chain Management Capability Maturity Model (CMM) Risk-Management CE DHF 510K PMN/PMA EU-Directives Process Validation Six-Sigma Technical Files/DMR CAPA NCMR SCAR pFMEA DFT/DFM DOE/Flow Gauge R&R 8D/5S Kaizen SPC

PROFESSIONAL EXPERIENCE:

Confidential, San Francisco, CA

Sr. Operations and Engineering Manager

Responsibilities:

• Management of the entire manufacturing operations and engineering of the start-up company that is bringing digital discovery to art with the revolutionary platform designed to help browse, collect, and display museum-quality art in home.

Confidential, Milpitas, CA

Sr. Engineering, Facility, Project Manager

Responsibilities:

• Managed 10 engineers, 3 supervisors and over 45 technicians/assemblers along with budgeting and maintenance of over $30M capital equipment(s) aimed at state of the art Confidential assemblies and Box-building in addition to quick turn NPI, as well as, managing the entire facility of multiple sites.
• Leaded projects for Confidential ’s from a wide-range of industries including military/aerospace, medical and industrial.

Confidential, San Francisco, CA

Sr. Quality Assurance Engineering Manager

Responsibilities:

• Managing QA Engineering and RA for Life Science Instruments.
• Liaise with multiple product development groups throughout the product-realization process to product-launch (i.e. Instrument, Software, IFC-Interface-Fluidic-Circuit and Reagent Transition from R&D to manufacturing).
• Established and implemented processes Products’ End-of-Life.

Confidential, San Jose, CA

Managing Director, Manufacturing and Production Operations

Responsibilities:

• Established optimum resource & equipment utilization, capacity efficiency, and process improvement, resulting in “achievement to targeted in the reduction of backlog from 25% to 4%” in three months.
• Implemented the quality system, lean-manufacturing for high technology cable harness assemblies, mechanical main-frame, electro-mechanical chassis in compliance with ISO9008/ISO13485 regulatory requirements for HVM (High-Volume-Manufacturing) along with Full Documentation, DOE, ECO, PCO, NCMR and customer returned via revised RMA process, resulted in 15% overall cost reduction.

Confidential, Mountain View, CA

Sr. Manufacturing Engineering Manager

Responsibilities:

• Design and author of assembly & test procedures, component selections, design documentation for system/PCA (i.e. schematics, BOM, assembly drawing) and mechanical components (i.e. PS, mechanical-chassis, Confidential -parts, fabrications, cable harness).
• Work within a Lean Six-Sigma/DFSS framework to periodically contribute to business/department-centric process improvement initiatives (emphasis on cycle-time/cost-reduction, design for robustness/reliability and removal of non-value-added steps)
• Technical manufacturing interface with CM for design and release of Confidential, mechanical/electro-mechanical components, including Confidential, cable harness, injection molding, material procurements and quality system

Confidential, Fremont, CA

Senior Lean Manufacturing Operations, IT and Quality Manager

Responsibilities:

• Enabled manufacturability, growth, profitability and competitive advantages for series of new Automatic Burn-in Test Systems ( Confidential ) beyond targeted goal within few months.
• Provided implementation-focused, high-impact solutions to a variety of company’s internal processes - Including qualification of new ERP Database (Expandable) to replace the old MRP system (Man-man/ASK) within six weeks.
• Reduced defective Confidential field returns by the factor of 20 percent within six months and established new MRB methodologies for ECO, field installation, and customer acceptance criteria.

Confidential, San Jose, CA

VP, Manufacturing and Engineering

Responsibilities:

• Collaborate with research & scientific community membership in vetting ‘ next-gen ” concepts and technology enablers targeting future products and innovations.
• Established the cross-departmental Confidential team to manage product introductions, improving the “achievement to targeted release date” from 50% to 80% in only six months.
• Realized a 25% reduction in manufacturing costs by successfully transitioning the in-house manufacturing of Confidential instruments ( Confidential ), servers, cables and components to contract manufacturing.
• Technical management of manufacturing/production of Mixed-Signal Confidential (s) for testing technically complex medical devices and capital equipment acquisitions (up to 20 million per year), in support of medical device manufacturers (i.e. Guidant, Siemens, Micro-Semi, Maxim, Supertex), as used for Implantable Pacemaker, Automated & Custom Medical Test-Equipments/Modules in compliance with regulatory departments and standards