SUMMARY:

A highly experienced and proven Mechanical Engineer with a detailed approach to product quality, design, manufacturing, and development in the medical device, computer, aerospace, and automotive industries. Principal strengths include product/process/equipment V&V, design and development, design review, equipment specification, root - cause investigation and product/process improvement. Exceptional problem solving, interpersonal, and communications skills

EXPERTISE IN:

• Product & Process Dev't
• Verification/Validation
• Project Management
• Documentation & CAD
• Systems Improvement
• Troubleshooting
• Equipment Procurement
• Technical Support
• Supplier Interaction

TECHNICAL SKILLS:

Technical: Minitab 16 & JMP statistical analysis / Six Sigma-Green Belt / CAD: SolidWorks & CATIA / Statistical Process Control (SPC) and Data Analysis / Design of Experiments (DOE) / Failure Mode and Effects Analysis (FMEA) / Design for Manufacturability (DFM) / Electrical Safety & Lockout/Tagout / Hydraulic Valves and Controls / Fundamentals of Gear Design / Ergonomics / ASME Y14.5M Geometric Dimensioning and Tolerancing

PROFESSIONAL EXPERIENCE:

Confidential - Carlsbad, CA

Sr. Quality Engineer

Responsibilities:

• Responsible for Quality Engineering support in the creation and development of Class II implantable spinal medical device products in compliance with 21 CFR Part 820 and ISO 13485.
• Performed Verification/Validation (V&V) for surgical implants and instrumentation sets. Wrote protocols and reports for FDA filing including: Sterilization, Cleaning, and Shipping.
• Reviewed and approved test protocols and reports for process operational and performance qualifications (OQ/PQ) and product Design Validation/Verification.
• Quality Engineering representative on New Product Development teams.
• Performed CAPA root-cause analysis, investigation and resolution planning.
• Created, reviewed, edited, and approved Change Orders to support R&D, Manufacturing, Regulatory Affairs, and Quality improvements using Agile software.
• Wrote or reviewed, improved, and approved Operating Procedures.
• Authored Quality Inspection Plans used by Quality Control.
• Performed risk analysis assessments using the FMEA approach.

Confidential - Temecula, CA

Sr. Quality Engineer/Sr. Mechanical Engineer, R&D - Medical Devices

Responsibilities:

• Performed medical device product verification/validation (V&V). Wrote, performed, and appproved protocols and reports for FDA filing including product operational and performance qualifications (OQ/PQ), Sterile/Nonsterile, Design Validation.
• Developed test fixtures and methods, validated test methods including Deployment Force, Tensile Testing, and HIAC Particle Counting. Performed statistical analyses to support protocol reports. Performed risk analyses.
• Supported manufacturing line transfer from Ireland to Temecula. Reviewed and documented line operations in Ireland prior to transfer. After transfer, reviewed and approved equipment qualification protocols and reports (IQ/OQ).
• Performed root-cause/failure analyses and identified solutions: Investigated customer complaints regarding stent delivery system deployment force/accuracy and device detachment. Performed design analyses and manufacturing process characterizations and developed functional tests to understand device performance and bond failures. Authored reports and presentations with recommended improvements to both Design and Manufacturing groups.
• Wrote, reviewed, and approved Change Orders to improve manufacturing processes and quality procedures.
• Developed, designed, and evaluated mechanical components, assemblies, processes and/or equipment.
• Conducted feasibility studies to verify capability and functionality.
• Supervised support personnel and coordinated project activities.
• Reviewed and coordinated supplier activities to support development.

Confidential - San Diego, CA

Sr. Mechanical Engineer

Responsibilities:

• Managed major sustaining engineering projects, which included developing schedules, drawing packages, design analysis, specifications, qualification test plans, cost savings, bills of materials and engineering change notices.
• Used SolidWorks 3D CAD package to prepare solid models and manufacturing drawings and Oracle and SAP enterprise systems for BOMs.
• Responsible for introducing a high-reliability, replacement electrical connnector for a critical customer application by creating specifications, soliciting competitive bids, managing suppliers, and conducting a qualification test plan. The connector improved the customer experience with a 23X reduction in communication faults and generated a cost savings in excess of $10M due to its lower unit cost (-66%) and retrofitability on existing PCBAs.
• Redesigned a large electromechanical PCBA to improve latch function, eliminate mechanical interferences causing damage to circuit components, fix discrepancies between hardware and documentation, and remove unnecessary components.
• Determined and eliminated the root-cause of field failures of a critical product latch system by designing a new latch with different material and less mass.

Confidential, San Diego, CA

Sr. Manufacturing Engineer

Responsibilities:

• Managed, developed, and controlled configuration of new, fully automated, equipment for drug discovery and high-volume screening applications.
• Drove, led, owned, and implemented product improvements by interfacing with design engineering and assembly technicians.
• Developed drawing trees, directed drafters and technical writers to publish controlled documentation that defined product manufacturing plans and assembly methods.
• Defined and administered Manufacturing Requirements Planning (MRP). Inputted plans and product definition to an Oracle database for Bills of Material and procurement of automation components and materials. Presented weekly progress and status to upper management.

Confidential, San Diego, CA

Manufacturing Development Engineer

Responsibilities:

• Developed and owned new machine modules from inception to maturity for fully automated, high-volume plastic printer cartridge manufacturing and assembly lines in a large, multiple shift production environment.
• Developed equipment procurement specifications; conducted supplier interaction; and provided design reviews, debugging, performed startup, and delivered mature processes.
• Some modules were replicated 15x for international manufacturing.
• Provided technical support and troubleshooting, direction and of technicians and operators. Managed process improvements, database mining and statistical analysis, line performance metric reporting. Directed technical writers to publish controlled documentation of operating, maintenance, and troubleshooting manuals. Supplied safe and ergonomic designs. Reduced cycle time and downtime. Improved production yields.
• Qualified processes and developed products using Design of Experiments methodology.
• Teamed with R&D and Materials engineers to assure product designs were compatible with manufacturing processes.
• Developed processes: mechanical assembly, simple machine vision inspection, ultrasonic plastic welding, packaging, helium mass spectrometer and pressure decay leak detection, adhesive thermal cure, custom spring forming, and bowlfeeders.

Confidential - Seattle, WA

Mechanical Design Engineer

Responsibilities:

• Member of the design team for an entirely new commercial airliner.
• Designed mechanical power transmission components for wing flap actuation.
• Components included gimbals, U-joints, shafts, housings, bearings, seals, castings and forgings.
• Modeled, designed and integrated components and assemblies utilizing CATIA 3D CAD.
• Directed drafters to produce machine component drawings.
• Interfaced with the Structures, Stress, Purchasing, and Material Groups.
• Employed a new bearing surface coating process to permit the use of titanium material for a critical weight savings.
• Improved the life and reliability of ballscrew actuators by initiating the investigation and use of two new materials.
• Generated design requirements, performed design analyses, and reviewed system and component tests to certify aircraft hydraulic systems.
• Performed computerized thermal analyses of the 767’s hydraulic system to optimize thermal performance and define design requirements for a military application.

Confidential - Detroit, MI

Automotive Product Development Engineer

Responsibilities:

• Designed, developed, purchased components, and built test equipment for automated measurement of steering and suspension parameters and component performance.
• Also, instrumented, tested and evaluated steering and suspension parameters and component performance.
• Designed and built systems to measure steering torque, translation and rotation at the tire/road interface. bench test hydraulic power steering gear and pump performance. measure vehicle ride and roll parameters.
• Planned and conducted transaxle performance and durability tests, analyzed results and made design recommendations, supervised mechanics.
• Initiated a dynamometer test program to collect gear and bearing life vs. load data and made reliability predictions.
• Planned and managed two successful transaxle test programs for new high-torque vehicle applications.