Robert Guthrie Email & Phone Number

Lafayette, Colorado, United States

Responsible for high visibility weekly Field Corrective Action update reports summarizing status of product notice and returns from customers. Reports sent to Sales Team Reps, managers, and RVPs. Support executive team meetings.

Louisville, Colorado, United States

PDP & NPI Enabling Technologies

Boulder, Colorado, United States

Hired by quality manager to support commercially released ultrasonic dissection device, full suite of hardware generators and PCBAs, and PHP pad product lines.

Boulder, Colorado, United States

Hired by quality manager to PPAP qualify critical battery/charger plastics and springs for 2nd generation ultrasonic piezo driven disposable dissection device & first-generation cordless product and NPQA lead for monopolar smoke evac. pencil. Managed multiple supplier ship to stock qualification component programs for laparoscopic RF sealer/divider products.

Greater Memphis Area

Recruited by Quality Manager to be project lead for fast-track custom Class I & II thoracic/lumbar device implants and instruments requiring, verification/validation documentation to meet surgeon requirements and patient timelines.

Charlottesville, Virginia Area

• Brought aboard by the Operations VP to develop a Class III ready quality system.
• Overhauled the NCMR process to pin point accountability, traceability, and ERP data performance metrics reducing MRB aging time from weeks to days.
• Spearheaded supplier CAPA corrective/preventative actions and managed daily MRB with supply chain alignment, resulting in a reduction of critical component NCMRs and associated manufacturing downtime improvement.
• As senior quality representative on executive staff, participated on quarterly quality reviews and was point of contact for 3rd party regulatory company audits.

Goleta, CA

• Recruited by Quality Director to manage component validation for 3.5M plastic injection mold transfer project.
• Supervised and wrote first time IQ/OQ validation qualifications for company wide production optical measurement systems exceeding corporate CAPA audit compliance mandate criteria.
• Revamped critical component specifications and authored technical justification documentation required to update criteria necessary to meet new process standards enabling new project launch.
• Completed corporate compliance project ahead of schedule and delivered first injection mold IQ and OQ component validation results from contract suppliers meeting crucial executive project milestone.

Santa Barbara, California Area

Edited and verified Clinical Study Reports and their supporting SAP based statistical tables, listings, and graphs.

Wheat Ridge, CO

Family run business that started with E-PROMS for Hewlett-Packard and expanded in to custom wire/coaxial cable assemblies as well as battery backup systems. Performed complete facility inventory and subsequent refinement of maintenance, calibration, & lease programs. Defined employee performance grades and training schedules all to ISO standards.

Longmont, CO

Involved in the inception and development of a non-profit, all-volunteer LongNet spin off network group that has become the premier Longmont/Boulder networking group. Performed audio-visual set up and was member of the programs committee.

Boulder, CO

• Collaborated with Sustaining Engineer Manager and Senior Sustaining Engineer in a comprehensive review of the Design History Files (DHF).
• Generated device history file ‘gap analysis’ reports of flagship product pulse oximeters, isolating critical FDA missing documentation, and validation & verification action items.
• Led European Union hazardous material ‘RoHS no lead’ compliance project team (marketing, materials, & engineering) for 300+ million revenue pulse oximetry PCBA’s sold to major medical OEM’s; GE, Welch Allyn, Phillips.
• Delivered complete, accurate flagship oximeter gap analysis reports before target deadline & kick-started critical oximetry PCBA RoHS outsource conversion to meet key customer commitment.

Greater Salt Lake City Area

• Recruited by Electrical Engineering Manager to spearhead a global RoHS conversion for the X-ray mobile fluoroscopy C-arm division.
• Verified and validated C-arm system critical RoHS compliant LCD monitors on schedule, retaining 18 million dollar supplier contract and meeting vital division ship.
• Authored and supervised verification test criteria, based on Design Controls, for first RoHS compliant CPU PCBA’s, transformers, and power supplies.
• Provided on time, compliant, LCD V&V approval for company’s first post FDA consent decree revised product. Executed PCBA RoHS shock/vibe & HAST verification protocol before obsolescence requirement.

Longmont, CO

• Recruited by former Maxtor colleague, VP of Operations, to manage supplier sourcing, qualification, and performance metrics for a technology startup.
• Delivered improvements to components and supplier processes through feedback, failure analysis and RTV.
• Initiated and organized the electrical and mechanical RoHS qualification of first and second generation 1” form factor 1.5-8GB product that met Sony, Samsung, & Phillips RoHS limits.
• Created test procedure and supervised supplier’s metal permeability & electro-less nickel process for improvement of new form factor critical brass drop-shock inertial latch link.
• Optimized process, design, and component quality, resulting in product going from 87K DPPM to 20K. Secured RoHS certification well before 2006 deadline, ensuring OEM contract.

Longmont, CO

• Reported to Director of Head/Media Supplier Engineering, to provide expertise in head suspension and head assembly manufacturing and component quality management for high volume PC disk drive.
• Co-authored Head Stack Assembly (HSA) instability test report which led to 30% drive level failure reduction and reliable linear integration capture system reducing final product waste.
• Performed Head Gimbal Assembly (HGA) and HSA process engineering support for overseas manufacturing facilities in China, Thailand and Japan.
• Qualified 3rd party HGA and HSA manufacturer in Shenzhen, China, playing integral role reducing cost of HGA/HSA assemblies. Lived on site, in China, for three months.
• Participated on corporate project team that converted a hard copy component qualification documentation system to an online approved supplier list (ASL) process, creating efficiency and cost saving feed back.
• Instrumental in qualification of key sub-assembly supplier, attaining significant cost savings while boosting quality, recapturing lost market share.

Milpitas, CA

• Partnered with Test Development Engineering to support high-volume, high-performance 3 1/2" HDD product teams with comparative component and assembly performance analysis.
• Coordinated unique disk ware, drive settings, labeling, and packaging requirements of strategic OEM accounts; DEC, Dell, Olivetti, Acer, Gateway, and Samsung.
• Led task force in reducing test screen time by one quarter, saving a major OEM thousands of dollars by expediting product inventory purge.
• Worked with product team in Japan, delivering critical data analysis support for a high revenue 3 1/2 inch disc drive, which established a new company record for time to market.

Ba, Pre-Med

Activities and Societies: Participated on the Fencing Team

Aa Degree, Biology, General

Activities and Societies: Ran Track and Cross Country

Certificate, Agricultural Mechanics