Contributing Engineering Manager/Staff Engineer
Del Mar, CA
A creative, highly dependable, team oriented professional with 23 years of advanced product design and concurrent process development expertise. A hands on builder and leader of teams in research, development, sustaining and manufacturing engineering for systems requiring the balanced application of hardware, electro-mechanical, pneumatic, and software capabilities. Has a successful project track record that, over time, has increased in scope, complexity, and responsibility. Applies a player-coach management approach; able to communicate persuasively, engagingly and clearly at all levels within an organization.
Authorized to work in the US for any employer
June 2014 to Present
• Designed, tested and patented and released a unique chucking device that supports and retains a rotating door latch on a door capture mechanism for a tube set on an intravenous (IV) large volume infusion pump. As the program manager and technical subject matter expert; generated project deliverables employing R&D, Supplier and Production Quality Engineering; Sourcing; Purchasing; Service; Clinical; Risk Management; and Marketing personnel; adhering to strict Quality Management System (QMS) requirements.
• Created and implemented an R&D SAP documentation process concurrent to releasing manufacture tooling and test fixtures; capturing physical configurations, performance specifications and application instructions that meet corporate QMS and FDA audit standards; ensuring uniform fabrication of new hardware and predictable performance.
• Designed, built, qualified, and released a robust, general use, electro-pneumatic-mechanical robot that accurately simulates the dynamic forces imparted by a human hand to the mechanical pump closure mechanism of an IV infusion pump. Platform durability enables the execution +0.5 million continuous, failure free, open and close cycles eliminating maintenance related test downtime.
• Designed and developed electro-magnetic shielded enclosure concepts that enable the use of IV infusion pumps in MRI environments. Consolidated voice of customer (VoC), usability, Pugh matrix studies (DFSS), systems requirement and risk analysis data into an optimal product configuration; collaborating with product/clinical marketing, engineering, risk/hazards and 3rd party vendors.
January 2012 to January 2013
• Hired, developed, and lead a 11-member team of Process and Quality Engineers tasked to install, commission, document, and validate a $90.0M, 150.0K sq.-ft., 140.0MWatt, production facility; fabricating large, high precision, “aluminum-glass-semiconductor” composite modules used to generate solar power.
• Organized team structure around 17 partitioned process equipment groups. Assigned ownership of equipment groups to individual engineers, creating “single-point” process group experts. This team structure ensured clear communication, maximized trouble shooting effectiveness and accelerated fault resolution plan execution, during “line-down” events.
• Executed successful factory commissioning review based on six-sigma quality principles utilizing process capability (Cpk) indices derived from throughput rate and quality data as the success criteria for each process equipment group.
February 2011 to August 2011
• Hands on leader of engineering group tasked with executing new product development and sustaining engineering programs that included third party OEM equipment integration.
• Partnered with technical marketing to develop and deliver a product road map and timeline. Executed near term incremental improvements to existing products and long term new product development that included material and assembly labor cost reductions.
• Redesigned an automated Microtiter screen maker used for Protein Crystallographic studies; configured to combine up to 26 different reagents using standard micro plates. New platform configuration enabled a 20% reduction in material and assembly labor costs, reduced weight by 45% (200 lbs.) and improved usability.
2007 to 2010
• Hiring, developed, and lead a 13-member engineering team tasked with creating a “next-generation” acute care life support ventilator product.
• Developed a detailed 510(k) ventilator product specification and managed program design and development phase release milestones based on FDA regulatory requirements relating to; data record keeping; verification and validation (V&V) testing; adhering to corporate ISO13485 and ISO14971 quality standards. Worked closely with product/clinical marketing to align technical capability specifications with customer requirements.
• Created and built a new prototype medical ventilator device comprised of five major interconnected subsystems; 1) multi-mount chassis/enclosure; 2) rotatable and detachable GUI; 3) modular electro-mechanical-pneumatic gas network; 4) power distribution and scalable battery backup system, and 5) on board self-contained DC air compressor enabling ventilator operation during emergency power outage. This platform was a highly modular Pneumatic, Mechanical, Electronic and Software controlled system.
• Managed $1.0M personnel and infrastructure budget supporting R&D machine shop, 3D prototype printing; 3D CAD/CAM and PLM software supporting multi-site user system for technical document vaulting and cross division access and sharing.
• Managed a $15M tooling and material budget to build a prototype ventilator product platform comprising machined, plastic/aluminum injected molded, sheet metal and OEM components and subassemblies.
• Surveyed, evaluated, negotiated, developed and activated new vendors to address unique engineering hardware design and manufacturing process challenges, enabling project deadlines to be achieved.
2004 to 2007
• Hired, developed and lead a diverse team of 10 technical experts composed of top notch Sr. Mechanical, Sr. Electrical, Firmware, Software, Draftsman/Design and Technician personnel tasked with sustaining and enhancing complex automated robotic magnetic tape data storage library product lines for Hewlett Packard.
• Developed, directed, and executed product enhancement projects based on three basic principles of engineering design based product cost reduction, reliability improvement, and performance enhancement. Direct application of these three principals to core product configurations and manufacturing operations shifted first-pass-yields from 60% to 95+% while minimizing labor and tooling costs.
• Identified and directed critical product platform design enhancements encompassing firmware stabilization; linear, rotary and structural mechanics; and more repeatable alignment, mounting, datum and measurement schemes aimed at reducing fixture overhead cost and maintenance.
• Identified, surveyed and developed new vendors used to fabricate high pressure aluminum and plastic injection mold components. Addressed issues relating to manufacturing capacity, material certification, paint and finish, Gage R&R, metrology, packaging, and first article inspection.
• Conducted Lean Manufacturing line support efforts to maximum uptime and real time fault recovery requiring; failure analysis; action and recovery plan execution; and implementing permanent fault resolution strategies using design reviews and the engineering-change-order (ECO) process.
2003 to 2004
• Developed and executed testing program to characterize excimer laser platform’s thermal performance aimed at increasing operating range specifications and reducing cost of ownership.
1999 to 2003
• Designed and built a complex metal-organic gas delivery system composed of sequenced valves, metering devices (MFCs), heated gas lines, liquid sensors, and safety interlocks. Three prototype platforms were sold that generated a one-time quarterly corporate revenue increase of $14M. Successful execution of this project resulted in the promotion to Sr. Mechanical Engineer.
• Created a precision 5-axis articulating mechanism that controls a semiconductor wafer’s orientation +/- 0.001” parallel to a fixed reference plane, under high vacuum, beating a +/- 0.005” tolerance specification. Mechanism reduced system setup time by 90% and reduced cost by 50%. Due to its stability, accuracy and ease of use this mechanism has been successfully operating for 10 years.
1995 to 1999
• Designed test programs and fixtures, derived from FMECA analysis, to test failure modes of complex electro-mechanical systems; high voltage network and microwave plasma generators; and precision gas delivery systems used for flow metering and dispensing. Continued growth in project size, complexity and responsibilities enabled me to be promoted to Sr. Reliability Engineer.
• Applied statistical methods (Weibull, Taguchi) to analyze accumulated test data to identify product weaknesses; validate product functional specifications; and guide corrective actions before product release.
• Successfully executed a 2-year reliability test program to characterize a new dual chamber wafer processing platform (the Producer), fulfilling the Product Development Process (PDP) reliability milestone; enabling on-time product release to market and securing a $1 billion market share.
1993 to 1995
• Successfully delivered to the FAA and trained government end users, a $0.5M project, programming enhancements to a Global Aircraft Emissions Forecast (GAEF) dynamic simulation software package.
1992 to 1993
• Created a legacy computer simulation program for Daimler-Benz, AG used to analyze the electro-mechanical performance of electric vehicles and guide their development.
Master of Science in Mechanical Engineering
Bachelor of Science in Mechanical Engineering
1989 to Present
License No. XE076421
SolidWorks Professional – Mechanical Design CSWP
May 2014 to Present
Certification ID: C-L6PP96N5AY
Cornell ENGR2000X: A Hands-on Introduction to (ANSYS)
Cert. ID: 872a389c6c9440b78f845c970a24facf
Apparatus Having Platforms Positioned for Precise Centering of Semiconductor Wafers during Processing (#US 6,793,766 B2)
Substrate Support Lift Mechanism (#US 7,871,470 B2)
Medical Ventilator (#US D643,535 S)
Hardware Design Expertise:
Complex component/assemblies; Surface modeling; Material compatibility and selection; O-ring sealed systems (high vacuum/pressurize systems); Fluid/Gas delivery systems, Pneumatic/Electro/Mechanical mechanisms; Compound gear drives; PLC/step/servo motor control; Structural design; Thermal systems; Radio frequency (RF)/Microwave (µWave) power network testing.
3D Modeling and Analysis:
SolidWorks; Pro-E Wildfire; ANSYS; CETOL 6-Sigma; Minitab; Weibull
Product Lifecycle Management (PLM) database Expertise:
SolidWorks Integrate Management/Teamcenter, SAP, SolidWorks Enterprise PDM, Pro-E Interlink, AGILE
Business Software Expertise:
Microsoft Word; Excel; Power Point; Project; Visio
– Standard Fabrication: Machining; Sheet Metal (bend/die/emboss); Welding.
– Molding/Casting: Plastic Injection; Aluminum Vacuum; High Pressure Die Casting; Liquid Injection (LIM); Reaction Inject Molding (RIM) molding.
– 3D Printing/Prototyping: Stratasys 3D Printing systems (*.SAT file); Stereo lithography (SLA).
Technical Standards and Quality Management Systems (QMS):
– ASME […] Geometric Dimensioning and Tolerance.
– IEC […] Medical Electrical Equipment; Basic Safety and Essential Performance.
– ISO […] 14971 Medical Devices/Medical Devices Risk Management.
– ISO 9001 Semiconductor Equipment and Life Science Automation