Jim Flock, mba

Hudson, OH • 216-***-**** • advhxe@r.postjobfree.com

QA + Engineer Design Controls expert NPI Post market

Delivering strategic leadership to optimize quality, efficiency, and reliability.

Dedicated, solution-oriented professional leveraging detailed testing and analytics to deliver high-quality, compliant medical device products that exceed customer expectations. Collaborative individual working closely with cross-functional teams implementing design control and risk management to communicate test results and deliver recommendations for product enhancements.

Natural leadership skills with expertise in quality assurance, design controls, MRI and Cardiac mapping medical devices, and electrical engineering unafraid to take on new challenges with vision and goals to guide the collaborative team. Self-motivated team player with exceptional organization, team mentorship, and problem-solving skills who excels in regulated, deadline-driven environments.

Areas of Expertise

Testing & QA Leadership (IQ/OQ/PQ)

Detailed Analysis & Reporting

Cross-functional Collaboration

Design Concept Engineering

Technical Report Authoring

Customer Satisfaction & Support

Test Strategy Development & Oversight

Continuous Improvements (DFM)

Root Cause Analysis & Troubleshooting

Reliability & Quality Maximization

Team Training & Motivating

Compliance Management

Attention to Detail (Gauge R and R)

Organization & Deadline Adherence

Effective Communications

Engineering and Business Tools

AgileMap (GMP)

Trackwise (Defect Tracking)

Helix (FMEA tracing)

Modern Requirements/Sharepoint

Seapine (Test Track)

Arena (Doc updates)

Windchill (BOMs/ChangeControl)

Azure DevOps (test cases)

SQL (pgAdmin)

Pivot Tables (histograms / plots)

Matlab (Test scripting)

Microwave Office (Circuit Analysis)

Altium (circuit load analysis)

Magnetom Avanto Clinical App

Labview (Mfg testing)

Professional Experience

2021 to Present • Philips Healthtech • Carlsbad, CA

Critical Care Ventilators (Respironics)

Sr. Design Quality Engineer (September 2021 to Present)

Product quality engineer on cross functional design team focused on CAPA investigation, root cause, and implementation planning.

Design quality assurance for the V60/V680 Ventilator product within the Respironics product portfolio.

Updated Statistical Techniques Process to meet 21 CRR 820 criteria

Deep review into FMEA and Risk Assessment for 35V CAPA Failure of V60 Critical Care Ventilator

System review to understand the design aspects of critical care Ventilation, ie Tidal Volume, Respiratory Rate, FiO2/PEEP

Assessment of design and circuit analysis for power mgmt. board, calculation of on-board components, in the ‘Vent’

2020 to 2021 • Medtronic • Independence, OH

Cardiac Ablation Systems business unit cardiac mapping medical devices (CardioInsight)

Principle Reliability Engineer (May 2020 to September 2021)

Trained and certified to Medtronic QMS and the owner of CardioInsight product for the Post Market Surveillance Report 2019. QA guidance for defining pre-market product development quality. Working in ISO 14971, 13485, and 10993.

Reliability Lead for Post Market Surveillance Report 2019 upholding regulatory requirement for over 70 systems worldwide

Test Case creation for SQA pre-market using paper-based development technique to assure non product tools are validated

Lead sustaining reliability engineer for design changes in post market including preparation for EUMDR (GSPR RMR, ERM)

Board member for return product investigation for CardioInsight Mapping System responsible to investigation complaints

Risk Management file owner for CardioInsight Mapping System maintain risk profile based on product performance data

2015 to 2020 • VIEWRAY, INC. • Oakwood Village, OH

Designer and manufacturer of the world’s first MRI-guided radiation therapy system that can image and treat cancer patients simultaneously.

MRI Systems Specialist QA (April 2018 to January 2020)

Promoted to spearhead engineering physics for software installations and lead the team through the entire testing cycle to ensure the delivery of a high quality product that exceeds customer expectations. Worked collaboratively with cross-functional teams to identify and resolve errors, while ensuring alignment with all regulatory requirements. Handled root cause analysis, troubleshooting, and reporting. Provided superior support to external customers and internal teams to drive continuous improvements and success.

Personally oversaw all MRI computer software installations with a direct tie to $180M in revenue

Served as the CAPA Owner, leading root cause analyses and using Ishikawa diagrams to pinpoint factors and enhance quality

Identified root causes of issues, including poorly manufactured coax cables, failed gradient amplifiers, system spikes, RF noise interference, and magnet inhomogeneity, and reported findings to improve reliability

Encouraged collaboration across the services and installation teams to meet deadlines and maximize quality

Senior Product Quality Assurance Engineer (November 2015 to April 2018)

Delivered technical leadership on a new radiation therapy MRI medical device. Performed testing and completed documentation for design history record (DHR) for the Linac-MRI project. Analyzed preliminary engineering design concepts, created test protocols, and reported findings. Identified opportunities for improvement and recommended changes to maximize performance outcomes.

Owned the full QA process, including NCR, DEV, and RW for a $6M project

Trained 20 customer medical physics teams, totaling 60 individuals, on the QA testing (ACR, NEMA, AAPM) of the MRI system

Evaluated all QA processes to ensure compliance with 21 CFR 820 and guided Process Owners on best practices for installation records, non-conformance disposition, and servicing and followed WEEE and RoHS directives

Served as Technical SME tasked with supporting installation activities at 18 locations across 9 countries

2015 • ALLTECH MEDICAL SYSTEMS AMERICA • Solon, OH

Investor-funded startup providing a newly designed Whole Body MRI system.

Design Controls Project Manager (June 2015 to October 2015)

Worked tenaciously to build a baseline test system from scratch to meet all process, quality, and regulatory requirements to a brand new 1.5Tesla Magnet Resonance Imaging “Comfort” product preparing to launch in the U.S. market.

Designed and actively managed test strategy for IEC Applied Part 060601-2-33 for the complete set of coils for the product

2012 to 2014 • VIEWRAY, INC. • Oakwood Village, OH

Designer and manufacturer of the world’s first MRI-guided radiation therapy system that can image and treat cancer patients simultaneously.

Senior Product Quality Assurance Engineer Test Engineer (December 2012 to June 2015)

Oversaw testing and verification of the MRI medical device with an emphasis on accuracy, reliability, and quality. Guided inspections and used findings to drive quality improvements to gradient coil and RF system suppliers. Leveraged analytics to resolve problems and made strategic, forward-thinking suggestions for enhanced product performance.

Led entire unit testing for Washington University, University of Wisconsin-Madison, and UCLA Ronald Regan Medical Center

EARLY CAREER

PHILIPS HEALTHCARE • System Verification Engineer PET/MRI software and system calibration (2011 to 2012)

VIVID IMAGING • Director of Operations, MRI Coil Repair Multivendor RF COIL (2009 to 2010)

PHILIPS HEALTHCARE • Senior RF Coil Engineer MRI, 1.5T, 3T, and 7T Coil and Electronics (2000 to 2008)

Education

MAASTRICHT UNIVERSITY • Master of Business Administration, International Business

JOHN CARROL UNIVERSITY • Bachelor of Science, Engineering Physics

WEST SIDE INSTITUTE OF TECHNOLOGY • Associate, Environmental Systems Technology

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