JORGE MONTOYA

Draper UT, ***** 417-***-**** acxgdp@r.postjobfree.com

SYSTEMS ENGINEER / ELECTRICAL QUALITY ENGINEER

NEW PRODUCT INTRODUCTION – PRODUCT DESIGN – QUALITY ENGINEERING Systems Architecture

Design Requirement

Generation

Design Controls

Risk Management

Quality Management

FDA Regulations

Quality Audits

Cross Functional Teams

Resourceful engineering professional with 7 years of progressive experience, with successful background in Healthcare optimizing surgical mobile imaging platforms. Expert in writing and managing system and subsystem requirements specifications pertaining to all aspects of x ray exposure and dose. Extensive experience in system verification, validation planning and execution, system testing, risk assessment, and quality engineering. Effective team leader and communicator who recruits and manages strong technical teams to resolve challenging compliance issues. Proactive, analytical problem solver, able to prevent and resolve technical issues in a timely and consistent manner.

KEY ACHIEVEMENTS

● Spearheaded planning and execution for system verification and validation by assembling highly qualified 8 team member to expertly execute more than 3,000 tests, user requirements, and system requirements.

● Reduced flat panel return rate by 1.5% in 3 months by identifying key gaps in testing protocols and implementing robust procedures and safeguards for testing methods.

● Created and managed additional system safety risk documents to accurately determine hazards inherent to system operation.

● NPI team member for introduction and system integration of new image receptor with flat panel technology. CAREER PROGRESSION

VARIAN MEDICAL SYSTEMS Salt Lake City, UT 2016

ELECTRICAL QUALITY ENGINEER II

GE HEALTHCARE Salt Lake City, UT 2009 – 2015

SYSTEMS ENGINEER, IQ 2013 – 2015

Directed team of engineers, clinical image specialist, and technical operators to efficiently engineer optimal medical image quality for mobile imaging c arm systems. Due to FDA Consent Decree injunction and with renewed commitment to excellence, ensured 100% quality and compliance with FDA regulations and guidelines. Resolved manufacturing and field issues. Conducted medical image processing FMEA creation and technical design review.

● Compiled and delivered more than 3,000 detailed system and user requirement specs on radiation dose exposure management, in addition to traceability objects and test flowdown, in compliance with IEC 60601 1 2nd, 3rd edition.

● Increased overall image quality by 15% by implementing image quality signature test as key quantitative measure of image quality.

● Improved testing verification accuracy by 25% by establishing uniform and consistent standards, including environmental conditions, calibration tools, work instructions and training.

● Exceeded past average execution time by 40% by introducing new protocol execution application.

● Administered design history files (DHF) to ensure strict adherence FDA and other regulatory bodies.

● Streamlined system problem reporting (SPRs) to enable better, quicker, and more accurate analysis.

● Planned and led LCD monitor design change for legacy systems, including verification, validation, and transfer. JORGE MONTOYA – PAGE 2

SYSTEMS ENGINEER, RISK MANAGEMENT 2011 – 2013

Investigated, analyzed, and reviewed failures discovered through customer reports and trending data. Performed exhaustive risk assessments to accurately predict possible system issues, reduce system downtime, and improve customer experience. Investigated system failures and malfunctions to determine appropriate corrective actions and preventative actions (CAPA). Drafted and maintained comprehensive risk management history records for future troubleshooting.

● Insured compliance with Quality Management System and cGMP standards, as well as FDA regulations: 21CFR Part 11 and Part 820 for Class II Medical Devices.

● Created 10 additional risk management documents for a more robust process and speedier complaint handling.

● Determined potential severity and probability of harm to patient due to system failures through cause mitigation tables and data analysis.

● Approved release of documents governed by design verification procedures only after thorough review.

● Conducted failure root cause analysis, verification, and testing to resolve problem reports and verify fixes. PRODUCT ENGINEER 2009 – 2011

Diagnosed and investigated field issues to resolve and mitigate customer complaints. Solved product safety, quality, and performance issues with thorough root cause analysis. Collaborated with clinical and quality team members to detect product issues and brainstorm potential solutions. Investigated product issues, failures, and malfunctions identified through customer complaints and regulatory non conformance.

● Led trend analyses, non conformance, and remediation activities for 8 legacy systems in compliance with FDA 21CFR Part 11 and Part 820 for Class II Medical Devices.

● Enhanced complaint handling process by introducing sorting methods for increased accuracy in medical device reporting (MDRs).

● Achieved and surpassed rigorous product quality and regulatory requirements.

● Provided technical support for backroom audits from the FDA and other governing bodies. EMPOWER PLAYGROUNDS Salt Lake City, UT 2008 – 2009 ELECTRICAL ENGINEERING INTERN

Designed and constructed prototype circuit device to store energy generated from merry go rounds in order to provide portable lighting to children in rural Ghana. Leveraging detailed test reports on circuit performance, modified and improved circuit to work more efficiently in hot African environments.

● Delivered 10 working devices designed for harsh environmental conditions in rural Ghana ahead of schedule.

● Managed organization budget, and saved approximately 35% by insourcing alternatives, such as in house design and fabrication of printed circuit boards (PCBs).

● Minimized costs by responsibly utilizing foundation funds and helping raise money through public donations. TECHNICAL PROFICIENCIES & STANDARDS

DOORs ● ClearQuest ● TrackWise ● EtQ ● Excel (Pareto, Fishbone, Pivot Tables) ● Minitab ● Linux ● Matlab Experimental Change Procedures (ECPs) ● Acceptance Test Procedures (ATPs) ● Validation Plans Engineering Change Orders (ECOs) ● FMEA/dFMEA ● V Model Lean Manufacturing ● Six Sigma ● Continuous Improvement ● Systems Integration 21CFR Part 11, 820 ● ISO 14971 ● ISO 13485 ● IEC 60601 1 2,3 EDUCATION

BS, ELECTRICAL ENGINEERING

Brigham Young University. Provo, UT

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