Ensure on-time/on-budget introduction of new products. Ensure effective and regular communication between R&D, Procurement, Demand/Supply Planning, Operations, Regulatory, Marketing, Quality, Finance, and other internal functions as well as with the supply base. Responsible for establishing and maintaining a robust supply chain in support of new product introduction efforts including supplier selection and development, supply chain risk management, spend management, aggregate demand forecasting, and design and manufacturing transfers. Also responsible for identifying cost improvement projects, alternate sourcing efforts, and best utilization of existing approved supplier base.- Developed and implemented robust Supplier Selection and Supply Chain Risk Assessment processes.- Identify and qualify new sources of supply, including localization of suppliers close to MicroVention manufacturing sites in Aliso Viejo, California and Alajuela, Costa Rica.- Developed and maintained detailed NPI Sourcing project plans for 30+ projects. - Developed methodology to green light projects using NPV & MIRR and prioritization by comparing value to level of effort on an impact graph- Led R&D buyers in conducting RFQs/RFPs, issuing of Ariba/SAP PO’s, manage vendor deliveries, and other procurement activities.- Mentor team in the areas of supply chain strategy, commodity management, cost savings, alternate and sourcing implementation.- Developed and maintained the sourcing library that defines the capability of the supply base.- Lead efforts to conduct specification review between suppliers and R&D to assist in the development of clearly defined technical specifications.- Development of utilizing SAP for the inventory/production controls and monitoring of R&D preproduction materials.- Support development of a robust component qualification process to support a more efficient alternate sourcing strategy.- Support buyers in BOM and Part Master creation and maintenance process.

Manage team of SQEs supporting a range of new product development and research and technology projects in the Neurovascular (NV) and Cerebrospinal Fluid (CSF) businesseso Supplier Qualification/Development: • Quality Engineering: Process Characterization/DOE Studies, Test Method Validations (TMV), Measurement System Analysis (MSA); Process Validations (Installation/Operational/Performance Qualifications [IQ/OQ/PQ]); Process Capability analysis (Cpk, Ppk, Tolerance Intervals); design/process Failure Modes, Effects, and Criticality Analysis (dFMEA, pFMEA); Component Qualification, and production control plans for Class II/III Medical Devices (Neurovascular Embolization/Revascularization Stents, Neurovascular Embolization Coils/Liquid System, Support/Guide/Micro Catheters, CSF Shunts/Drainage Systems/Valves) • Program/Project management of a portfolio of NPD projects for SQE activities during the development cycle.o Mergers & Acquisitions: Key member of due diligence team providing input on Quality Management System (design controls, supplier controls), manufacturing process capability, and product qualification readiness of target company. Developed pre-deal close and post-deal close SQE requirements. Managed post-deal close integration activities, including design/manufacturing transfers.o Key Strategic New Product Development Project: Design transfer and manufacturing scale up.- Developed and implemented component (Production Part Approval Process [PPAP]) and finished medical device qualification processes at overseas robotic guidance platform site.- Led development of PPAP process at the Brain division (eight sites) and key member of developing PPAP at the global/corporate level.o Mentor engineers in Project Management, Lean Six Sigma, Quality Engineering, Manufacturing Technologies, and Design Engineering.

Ormco Operating Company: Sr. Supplier Development/Value Analysis Value Engineering Engineer (VAVE)- Performed Value Analysis Value Engineering (VAVE) on newly developed and existing Class I/II Orthodontic (ISO 13485) medical devices and manufacturing processes (stamping, machining, injection molding, laser welding). Led contract and price negotiations with key Suppliers. Personally responsible for delivering $750K-$2M in annual savings. - Utilized Lean Six Sigma & project management methodologies with existing suppliers, to qualify new suppliers, and to process improve internal processes to provide Ormco world-class products and/or services.- Performed Design Verification and Process Validation (IQ/OQ/PQ).- Review Supplier Performance/Ratings (Quality, Delivery, Cost, Innovation).- Lead contract and price negotiations with key Suppliers.- Mentored engineers in Lean Six Sigma, Design for Manufacturability, and Design Engineering.- Perform Risk Management and mitigation in accordance with ISO 14971.- Extensive international business travel to Mexico.

Managed team of Program/Project Managers that were responsible for the portfolio of Supply Chain projects. Led cross-functional teams to support the continuous improvement of Supply Chain processes, initiatives, and major utility infrastructure construction projects that had a significant corporate-wide business impact. • Led team in Corporate Transformation Initiative to implement SAP to automate procurement of goods and services ($4B worth of spend) to improve resource utilization and reduce spending - Provided review, approval, and implementation of Procurement SAP processes from Purchase Requisition through Supplier Payment (“REQ to Check”) on 75+ new or extensively revised policies/procedures/work instructions.• Utilized MS Project and Excel to develop project/resource plans to effectively track milestone dates and efficiently match the organization’s size to the workload• Established Post Award Contract Management process for Major Projects ($50M-$2B) group. Developed software tools using Excel and Access for monitoring spend (including Earned Value Analysis), deliverables, design/field/contract changes, issues/action items, risks and opportunities, and schedule.• Project Manager for Document Management/Retention software implementation that was rolled out enterprise wide. Enabled extensive transformation from paper processes to electronic processes, thereby reducing labor efforts.

Managed team of Engineers to support the pursuit, order capture, and new product (pilot controls and in-cabin entertainment systems) development process by providing leadership of recurring cost management planning and cost validation against the new product business case. Presented to senior leadership during project/design/phase gate reviews.• Built West Coast aerospace division’s (Electro-Mechanical Systems and Cabin Systems) operation for Design To Cost (DTC) capabilities. Utilized MS Project and Excel to develop DTC schedules and spend plans.• Applied Design for Manufacturability and Assembly (DFMA) process early in the development cycle to maximize production cost savings (identified approximately $20M in annual savings across all product lines) for technically challenging and complex Pilot Control Systems and Horizontal Stabilizer Trim Actuators.• Introduced and implemented should-cost software (Boothroyd Dewhurst – DFMA) tool that determined manufacturing costs for various processes (casting, machining, welding, sheet metal, etc.) to help negotiate lower Supplier pricing.• Cross-functional team member of Supplier selection team. Performed Supplier process reviews, on-site audits, and performed cost reduction (goal of 5% annually) product reviews.• Hired and recruited new employees, assigned tasks/projects, mentored and counseled staff. Managed discretionary/controllable budgets, and staffing forecasts.• Communicated DTC awareness, lessons learned, and capabilities at Lean Development Conferences conducted at West Coast sites.• Improved process efficiency through use of Lean (5S, Kaizen, Value Stream Mapping, Eliminating 7 Types of Waste).

Managed and directed Ride & Show staff (department of 25 with 10 direct reports) in the design, construction, and rehabilitation of amusement ride structures and vehicles with capital budgets of $500K to $20M. Managed portfolio of NPD projects for R&D and approved project/design/phase gate reviews.• Managed/reviewed/approved staff work product: finite element analysis (FEA) for stress (including fatigue), risk/hazard analysis, FMECA, Design of Experiments (DOE), dynamic & kinematic analysis, material selection in corrosive environments, heat treating, hydraulic/pneumatic analysis; developing conceptual design and production design/drawing packages (using 3D solid models with SolidWorks) of welded ride track and supporting structure, ride vehicle restraints (gears, bearings, linkages, shafting, fasteners), ride vehicle composite bodies, vehicles chassis, running gear (wheels, bearings, tow bars) and Americans with Disabilities Act compliant ride vehicles.•Led the Change Control Board (CCB) and developed effective relationships in order to coordinate design and procedural changes that affect configuration management of documents and products.•Created financial models (NPV/IRR) for capital planning to determine project justification and/or priority.•Utilizing MS Project and Excel to develop detailed resource/manpower plans and project schedules.• Co-lead that established the resort quality assurance program. This included development of the Quality Manual and Quality Management System, Confined Space Operation and Permitting, Compressed Gas Storage Operation, Pressure Vessel Operation and Permitting, Fall Protection, Equipment Calibration, Design Control, Inspection Procedures, Assembly Procedures, and Welding Processes (per AWS & ASME).•Hired and recruited new employees, assign tasks/projects, mentored and counseled staff.

Sole proprietor of an engineering consulting business, specializing in new product development, engineering analysis (stress, heat transfer, fluid flow), and design for manufacturability & quality. Extensive customer/client interface during project development and implementation. Performed marketing and sales as well as engineering functions.

Managed pharmaceutical manufacturing projects related to high volume plastic injection molded medical devices (ISO 13485, Class I/II) & equipment to ensure on time delivery, meeting budgetary goals, and FDA GMP/ISO 9002 compliance.- Designed class I/II medical device product/packaging (using AutoCAD/Mechanical Desktop). Conducted Design Verification and Process Validation (IQ/OQ/PQ) of products and machinery.- Wrote Statement of Work documents to provide Supplier direction. On-site review of Suppliers for compliance to specifications and process improvement implementation.- Applied Statistical Process Control (SPC), FMEA, DOE, and process capability studies to improve product quality and reduce manufacturing costs.- Environmental, Health, & Safety Facility Representative: * Responsible for maintaining and complying with Cal/OSHA Injury& Illness Prevention Program (Hazard Assessment, Hazard Communication, Accident/Exposure investigation). * Responsible for maintaining and complying with Cal/OSHA Lockout/Blockout Program.- Developed MS Project schedules to determine critical paths and bottlenecks.- Supervised over twenty manufacturing personnel during weekend shifts.- Conducted training seminars for over 100 employees concerning safety, OSHA and EPA regulations, Production, and Quality Control.- Performed NPV and IRR financial analysis for capital projects.

Paccar Inc., Huntington Park, CAProduct Design Engineer – Research & Development, Oilfield/Industrial Equipment“Cradle to grave” design of positive displacement hydraulic pump (Trico Triplex Pumps) assemblies used in oilfield production and industrial applications. • Led teams in cross-functional product development projects that were presented to Marketing Dept., Executive Staff, and customers• Utilized FEA, fatigue analysis, fluid flow analysis, solid modeling to develop design drawings, dFMEA, material selection, and heat transfer to design metallic high-pressure (up to 20,000 psi) pumps and related piping systems• Developed procedures for ISO 9001 and American Petroleum Institute (API) certification• Supervised junior engineers and drafters for product design using ASME Sec. VIII, ASME B31.3, and National Association of Corrosion Engineers MRO175.Puroflow Corp. (Donaldson Co.), Santa Monica, CAProject Engineer – Research & Development, Aerospace• New product development of pneumatic solenoid valves, hydraulic check valves, pneumatic/hydraulic relief valves, pneumatic/hydraulic flow control valves, water purification systems using ultraviolet light, and filters elements used in aerospace and industrial applications.• Performed FEA/fatigue analysis, fluid flow analysis, solid modeling to develop design drawings, component testing, field service engineering, wrote and orally presented new design proposals based on customer specifications.Boeing, Space Division, Downey, CAMember of the Technical Staff – Fuel Cell Systems Engineering, Aerospace• Conducted fluid flow and heat transfer analysis of cryogenic oxygen and hydrogen for the fuel cell power generation system on the Space Shuttle. • Performed monitoring of fuel cell system during Space Shuttle missions. • Participated in dFMEAs of fuel cell systems • Technical liaison for 3000 psi pneumatic control valve and fuel cell Suppliers.