Robert Guthrie has over 20 years of experience in quality engineering roles for medical device companies. He has expertise in quality systems, regulations, and new product development. Currently he works as a Senior Design Quality Engineer, where he ensures projects meet deliverables and compliance standards. Previously he has held roles managing quality systems, supplier quality, and validation programs. He has extensive experience with FDA regulations and working with cross-functional teams on new product launches.

1. Robert Guthrie
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rbguthrie@yahoo.com  7175 Dry Creek Court, Niwot, CO 80503  720-838-4197
Senior Design Quality Engineer
Leader and versatile Project Engineer with expertise in design, development, qualification and manufacture of high-
technology electro-mechanical systems and FDA regulated medical devices and instruments.
 Expert knowledge of statistical process control (SPC), Lean Manufacturing / Six Sigma, failure modes and effects
analysis (FMEA), design for manufacturability (DFM), DOE analysis, root cause FA/FDA hazard & risk analysis,
geometric dimensioning and tolerancing (GD&T), mistake proofing/Poka-Yoke, short and long term gage capability.
 Energetic and organized, ensuring on-target project management, meeting all deliverables of multiple initiatives.
 Thorough knowledge of technical procedures, documentation, and compliance with DoD MIL-STD-962, FDA
Title 21 CFR 803, 806, 807, 820, & 892, ISO 9001, ISO 13485, SOR/98-282, IPC, UL, and CE regulations.
 Collaborative, engaging communicator who pro-actively liaisons with cross-functional teams, customers and
suppliers using succinct status reporting throughout new product lifecycle enabling winning product offerings. MS
Office, Project & Visio fluent.
EXPERIENCE
MAETRICS, Monument, CO 2016 - Present
MEDTRONIC SPINAL & BIOLOGICS, Memphis, TN 2015 - 2016
Design Quality Engineer (World Rapid Development Department) – Contractor
Recruited by Quality Manager to be project lead for fast track, small batch,customClass I & II thoracic/lumbar device
implants and instruments requiring, verification/validation documentation to meet surgeon specifications and patient
timelines. Project manager for FDA approved limited run customimplants for the Australian/New Zealand market.
MICROAIRE SURGICAL INSTRUMENTS, Charlottesville, VA 2013 – 2015
Senior Quality Systems Engineer
Brought aboard by the Operations VP to develop a Class III ready quality system.
 Spearheaded supplier NCMR as well as CAPA actions and managed daily MRB with supply chain alignment,
resulting in a reduction of critical component NCMRs and associated manufacturing downtime improvement.
 Executed desktop supplier audit of gamma sterilized disposable lavage product line with CAPA bioburden actions.
 As seniorquality representative on executive staff, participated on quarterly quality reviews and was point of
contact for 3rd
party regulatory company audits.
MEDTRONIC NEUROSURGERY, Goleta, CA 2011 - 2013
Project/Quality Engineer – Contractor
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.
 Updated legacy component drawing specifications and authored DHF justification documentation required to update
criteria necessary in order to meet new process standards thus enabling injection mold project launch.
 Completed corporate compliance project ahead of schedule and delivered first injection mold IQ and OQ
component validation resultsfrom contract suppliers meeting crucial executive project milestone.
ALLERGAN MEDICAL, Goleta, CA 2010 - 2011
QC Specialist/Biostatistics Group – Contractor
Edited and recalculated Clinical Study Reports and their supporting SAP based statisticaltables, listings, and graphs.

2. Robert Guthrie
Page 2 rbguthrie@yahoo.com 720-838-4197
RAPPORT, INC, Wheat Ridge, CO 2009
Manufacturing & ISO 9001 Consulting < Recommended for full certification 12/09 >
Expert consultant for local business that manufactured customwire/shielded cable assemblies and battery backup systems.
Executed total overview of company capital inventory and resulting re-write of maintenance,calibration,& lease programs.
Identified and defined all employee workerperformance grades & refined training schedules to comply with ISO standards
COVIDIEN, Boulder, CO 4/2008 – 11/2008
Sustaining Engineer & Project Team Lead - Contractor
Provided a comprehensive review of the newly acquired Nellcor respiratory division Design History Files (DHF), in
collaboration with the Sustaining Engineer Managerand Senior Sustaining Engineer.
 Presented DHF ‘gap analysis’ reports of flagship product Class II pulse oximeters to include ensuring compliance to
current standards and regulations,clinical studies, validation & verification qualification, & 510(k) action items.
 Team Lead for European Union hazardous material ‘RoHS no lead’ compliance project (marketing, materials, &
engineering) for 300+ million in revenue pulse oximetry proprietary PCBA consignment product sold to major
medical OEM’s; GE, Welch Allyn, Phillips, Space Labs, & Fukuda Denshi.
 Delivered critical,detailed,oximeter gap analysis reports before target deadline & kick-started oximetry PCBA
RoHS no-lead conversion outsource project meeting key customer delivery commitment.
GE HEALTHCARE TECHNOLOGIES, Salt Lake City, UT 2007 – 2008
Component Project Engineer - Contractor
Recruited by Electrical Engineering Manager to spearhead the GE medical device global RoHS conversion of the Class II X-
ray mobile fluoroscopy C-arm product division.
• Executed the validation of the new RoHS compliant LCD systemmonitors on schedule, retaining 18 million dollar
supplier contract and meeting vital division ship date. pFMEA refined based on unique CAPA data mining exercise.
• Composed and supervised verification test criteria based on risk analysis and Design Controls of first RoHS
compliant CPU PCBA’s, transformers, and power supplies.
• Provided approved on time LCD V&V report for company’s first post FDA consent decree compliant product.
Developed & executed elaborate PCBA RoHS shock/vibe/HASTverification report before obsolescence deadline.
CORNICE, INC. Longmont, CO 2004 – 2006
Staff Supplier Quality Engineer
Enlisted by former Maxtor colleague, VP of Operations, to manage supplier sourcing,product qualification, and process
performance metrics for a new micro disk drive technology startup. Product ultimately used in Samsung Korean cell phones.
• Company lead for the electrical and mechanical RoHS qualification of first and second-generation 1” form factor
1.5-8GB microdrive product resulting in Sony, Samsung, & Phillips WEEE limit certification.
• Created the test criteria and supervised supplier’s metal permeability & electro-less nickel manufacturing process for
improvement of new form factor crucial brass drop-shock inertia latch link to meet stricter drop-shock specifications.
• Optimized process, design,and component quality,resulting in product going from 87K to 20K DPPM. Completed
RoHS certification before 2006 deadline,ensuring OEM contract shipments.
EDUCATION & PROFESSIONAL DEVELOPMENT
BA – Pre-med, California State University Fullerton, Fullerton, CA
Course - Disk Drive Magnetics, University of Santa Clara, Santa Clara, CA
Course - Quality Management Systems, GE Healthcare, Salt Lake City, UT
Course – Industrial Sterilization for Medical Devices, AAMI, Alexandria, VA
Volunteer Junior Achievement Instructor – Salt Lake City
Peace Corps Volunteer – Ghana, West Africa