Quality Engineer Qualcomm Incorporated

David D. Duff

**** ****** ***** *** ***** CA ****4 858-***-**** *****.****@*****.***

Summary

B. S. Mechanical Engineering. CQE. Post Market Surveillance and PSUR. ISO 13485 Lead Auditor. Supplier Quality Audit training by ASQ. Daily usage of SAP, Agile, and HIS BOM-Intelligence. Knowledge of Silicon Expert and Windchill. ISO 13485 2016 by NSF. XRF Receiving Inspector and XRF SME sign-off. QA and Operations process improvements to improve communication and resolve problems. PWB design and fabrication Pick and Place equipment, SMT, selective solder, cable assemblies. Experience in sheet metal fabrication, N/C machine, injection molding. SPC analysis and interpretation, Root Cause Analysis, FMEA, 5 Whys, 8Ds.

Professional Experience

Intuitive Surgical May 2022-Present

Supplier Quality Engineer

Contingent Worker – Full Remote

Regulatory submission for new product with South Korea

Variance/Non-Conformance resolution for ION suppliers

SCAR resolution for electronic supplier, 16 assemblies

Regulatory application for new product. MSDS and material composition documentation

First Human Use trials. Data collection and preparation. Receiving Inspection records demonstrate stable supply chain.

Training in Intuitive Surgical procedures

Abbott Vascular October 2021-March 2022

Supplier Quality Engineer

Contract thru Manpower

Equipment Validation Reports

Non-Conformance of injection molded and extruded parts

Maintenance Change Orders

Supplier Change Notices

Supplier qualification and maintenance.

Supplier evaluation and change notice.

Supplier non-conformance and SCAR preparation.

Supplier Quality Assurance training.

Becton Dickinson Carefusion October 2020-February 2021

Supplier Quality Engineer

Contract thru Manpower

510(k) Premarket Notification of infusion products. Performing 510k tests of common sanitizers on current product. Observing for surface degradation and for ingress of solution into keypad and buttons.

Supplier Quality Agreement CAPA. Screening of current ASL for completed quality agreement and for completed supplier risk classification form.

Supplier Risk Classification CAPA. Screening of current ASL for properly assigned class E suppliers. In particular reviewed for completed justification statement that a supplier quality agreement not warranted.

Test Measurement Verification for injection molded body including Gauge R&R and ANOVA analysis

Supplier Quality Assurance training. Becton Dickinson training for supplier quality agreement, supplier risk classification assignment, SCAR creation and processing, CAPA creation and processing, plus more…..

Cobham Advanced Electronics Solutions December 2019-February 2020

Supplier Quality Engineer

SCAR creation for supplier providing laser scribe process in aluminum housing. Review of problem material found by production QA and investigation with supplier.

SCAR analysis: Dimensional analysis of press-fit feedthru into aluminum chassis. Identified ASME-Y-14.5 GDT analysis error, positional tolerance was actually inherent interference in the original design. Found tolerance stack-up combination where acceptable dimensions allowed for unacceptable assembly issues.

SCAR Resolution: Connector and flex-assembly were incorrectly identified as having inadequate solder fill in PTH per IPC 610. Holes were vias and not used with PTH component. Duplication of SCARs. Vendor corrective action was found to be acceptable.

Data base clean up allowed SAP to accurately track each item currently held in MRB through to resolution. Eliminated use of Excel spreadsheet for the same person. In process.

XRF Inspection SME: Review of XRF results following receiving inspection. Trainer for XRF operation by hourly staff.

XRF Process Standard: Identified duplication of effort in two sequential steps and the simplification, reduction of effort, that could produce time saving. In process.

Supplier audit schedule organization for 2020 for Hi-Rel programs.

Qualcomm Supplier Audit: Supplier development, auditor, review team for Volex U.S. and Guadalajara, Mexico. Reviewed supplier capability, production capacity, technology, and documentation methodology.

Cobham Advanced Electronics Solutions June 2017-December 2019

Components Engineer

XRF Receiving Inspector & XRF SME representative: XRF Inspection at Incoming Receiving to identify tin-lead content. XRF SME sign-off for all electronics received.

QA Process Improvements: Identified irregularities in QA processes, process improvement to identify/communicate hot items, waffle pack handling improvements, identify attrition rates, dry box repairs for MRB.

DMS Coordinator: Comparable to CAPA Administrator. Administer online DMS Tool. Enter new items to track, identify affected assemblies, identify responsible stakeholders from Purchasing, Program Management, Engineering. Track progress toward completion.

PCN Manager: Created & developed PCN tracking system. Receive PCNs from multiple sources, research immediate options, identify and categorize severity of change, assign initial action required.

IPC 610 Certification Spring 2018

CQE & ISO 13485 Training January 2016-June 2016

CQE Training includes: QMS methodology, Process Control and Continuous Improvement, Statistical Tools and Applications, SPC and Trend Analysis, Probability, FMEA, DoE, Risk Management.

ISO 13485 2016: 2003 to 2016 correspondence and comparison, MDSAP (Medical Device Single Audit Program), GHTF N19 NC grading.

Supplier Quality audit training, scheduling, the audit plan, formal report and follow up.

Ametek Programmable Power December 2013-July 2014

Components Engineer/Receiving Inspector

Led firmware upgrade for Ethernet port. Interface to Lantronix tech support, identified options to guide Ametek firmware upgrade for software engineers

Receiving Inspector - Performed receiving inspection duties for QA for all off the shelf components.

Responsible for ROHS/REACH compliance conversion, document standardization, and document revision. Conflict minerals and social responsibility. Interface between engineering teams in San Diego and Bangalore, India.

Supplier development and first article review with Purchasing and QA, second source development. Printed circuit boards, cable assemblies, transformers.

Continuous improvement process. Created preferred manufacturer index for power products, caps, logic devices. Resource for engineering, purchasing, manufacturing departments.

Supplier development for resistive touch display for next generation product. Identified 30mmx80mm resistive color display by Three Five Corp. along with alternate suppliers. Reviewed competitor’s specifications and obtained samples for engineering review.

Negotiated change notice agreements with supplier. Created/released rework procedure to recover discrepant sheet metal fabrication and return to deliverable product

Developed NDAs with new supplier and Ametek business and legal staff.

Greenlee Textron Incorporated October 2011-August 2013

Components Engineer/Supply Chain Engineer - Contract

Developed ROHS compliance strategy to ensure compliance. Includes documentation and sourcing guidelines.

Continuous improvement technique. Created corporate component database. Consolidated parts lists (BOM) from multiple divisions into single database with basic parameter lookup. Consolidated buying power and eliminated duplicates. Quick reference list for Engineering and Operations.

Sourced electronic components including IC’s, passives, memory, audio, switches. Evaluated new suppliers and products for compatibility to Greenlee designs requirements.

Developed custom SMT battery terminal and antenna to convert thru-hole design to SMT, full pick and place. Developed and spec’d tape/reel packaging requirements.

Developed custom PWB carrier for SMT assembly line, supports and aligns SMT antenna from pick ‘n place through reflow. Doubles as assembly aid for manual rework.

Qualcomm Incorporated April 1996-January 2011

Senior Components Engineer

Chemicals and Qualcomm proprietary reagents for Failure Analysis lab, CDMA chipset business unit. Supported procurement and inventory of custom and off-the-shelf chemicals and reagents.

Responsible for ROHS compliance conversion, document conversion.

Supplier development, auditor, review team for Volex U.S. and Guadalajara, Mexico. Reviewed supplier capability, production capacity, technology, and documentation methodology.

Developed strategy with purchasing for risk reduction (mitigation), second source development. Identify component obsolescence trends and negotiate strategy with suppliers to prevent shortages and production delays.

Developed and presented training to engineers and support staff. Responsible for training on preferred commercial and proprietary fasteners to Engineering Support Services engineers and support personnel. Ensured compliance to Qualcomm preferred standards.

Created corrective action plan to address failure in cell phone speaker. Identified defect, negotiated change notice with manufacturer. Identified proper RMA path with Asian supplier and communicated unique procedure with Qualcomm purchasing staff.

Supported ASIC failure analysis & investigative lab and their chemical & reagent usage.

Familiar with packaging materials and practices.

Sourced electro-mechanical products, vibe motors, camera modules and sockets, sensors for cell phones providing increased functionality to meet customer requirements.

Continuous improvement. Authored corporate wide documentation standard for generic fasteners to reduce cost and simplify sourcing.

Awarded patent for conformable proximity sensor which protects tractor-trailer vehicles end-to-end equipped with Qualcomm OmniTRACS system.

Ryan Aeronautical February 1992-May 1994

Mechanical Design Engineer Avionics Dept. - UAV

Designed electronic enclosures for avionics systems and coordinated the manufacture of prototypes.

Identified design flaws of avionics systems and recommended new installation methods that reduced assembly time.

Designed modular chassis for Unmanned Air Vehicle avionics system increasing the flexibility of system functionality and reducing cost.

General Dynamics Convair Division January 1986-January 1991

Mechanical Design Engineer Cruise Missile Avionics Dept.

Designed mechanical enclosures for avionics systems and coordinated the manufacture of prototypes.

Identified design flaw of Avionics system and recommended new installation methods that reduced assembly time.

Created standardized drafting standard for PWB drawings reducing the time needed to release documentation.

Assigned Temporary Duty with General Dynamics Land Systems Division, providing current electronics design practices for improved performance of vehicle electronics.

Represented Avionics Engineering Department during Customer Review of manufacturing problems, provided resolution for ongoing manufacturing flaws and reducing production rework.

Education

BSME Mechanical Engineering, Cleveland State University

Certified Quality Engineer June 2016, 93986

ISO 13485 Lead Auditor August 2021

Supplier Quality Management through ASQ March 2016

ISO 13485:2016 Medical Device Single Audit Program & Regulatory Training June 2016

IPC 610 Rev G 2018

Continuing Education & Training: Creating Effective Technical Presentations, Mentor CAD Design Layout Tools, ESD and Moisture Sensitivity Training, MMIC Design and Fabrication UC Irvine, MENTOR PWB design tools Qualcomm Incorporated, ITAR training Qualcomm Incorporated.

Patent: 7714719 Field Disturbance Sensor Utilizing Leaky or Radiating Coaxial Cable for a Conformable Antenna Pattern

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