Ryan Hanlon
Londonderry,NH
Summary
With a robust background at Philips Healthcare, I excel in leveraging cross-functional teamwork and innovative thinking to enhance risk management and post-market surveillance. My expertise includes Philips Six Sigma Green Belt Training and solid experience in quality system design controls, underscored by a track record of leading successful project teams and developing ISO-compliant strategies.
Overview
13
13
years of professional experience
Work History
Senior Risk Management Quality Engineer
Philips Healthcare
12.2024 - Current
- Leading team responsible for developing post market surveillance codes for risk management
- Part of project team for updating risk management framework
- Ownership and author of Initial Impact Assessments/ Health Hazard Evaluations (IIA/HHE’s)
Risk Management Quality Engineer
Philips Healthcare
04.2020 - 12.2024
- Developed strategy to transition legacy risk management files to ISO 14971:2019 compliant documents with connections to post market
- Updated RMM risk ID’s leveraging post market data analysis and PHA development
- Led small team that developed and maintained risk management and post-market surveillance codes
- Participated in multiple CAPA teams focused on quality and regulatory requirements
- Trained and participated in business audits for FDA and EU Notified Body in front and back rooms
- Leading team responsible for complaint handling coding escalations
- Created procedure and provided risk assessments to post market surveillance team for EU MIR form and NMPA adverse events
- Developed of EU MDR PMS procedures and templates, and trained team members on plans and report procedures
- Owned Initial Impact Assessments and Health Hazard Evaluations
- Created Post Market Surveillance plans and reports across multiple product lines and businesses
- Contributed to TrackWise QCM complaint handling system recoding efforts by training and leading a team of recoders
- Reviewed risk documentation, and made recommendations for updates for EU MDR compliance and IEC 62366-1:2015 compliance
- Collaborated with cross-functional teams to update business risk documents with new risks and hazards identified in PMS analysis or risk assessments
R&D Consultant
Endobetes, Inc.
01.2016 - 09.2022
- Early product development work around an implantable GI device using a catheter based deployment system
- Product design, manufacturing, benchtop testing, pre-clinical animal testing, and patent support
- Development of a quality system to support a new company heading towards a first in man clinical study
- Patent: Application # 16046592 (Lumen reinforcement and anchoring system)
EU MDR Quality Specialist
Philips Healthcare
03.2019 - 04.2020
- Part of cross-functional team in an effort to gain compliance to MDR 2017/745 focusing specifically on Post-Market Surveillance processes and DHF remediation
- Representative for Post Market Surveillance and Risk Management on EU MDR project within business
- Created gap assessments for the local business in the area of Post Market Surveillance
- Implemented Post-Market Surveillance plans, and created corresponding reports across the business
R&D Engineering Consultant
Instylla, Inc.
05.2017 - 12.2017
- Vascular hydrogel embolization product; Benchtop test method development and documentation
- Pre-clinical animal testing and early intervascular dual lumen catheter development
- Quality system support and documentation support
- Writing test protocols and reports for validation and verification test methods
Clinical Engineering Specialist
GI Dynamics, Inc.
01.2015 - 08.2015
- International human case proctor as part of a clinical engineering team travelling to domestic clinical sites in an FDA pivotal trial as well as international commercial and clinical sites
- Assisted clinical team in developing changes to study protocols, case and consent forms
- Sterile procedures experience in an operating room setting as well as an endoscopy suite
- International physician trainer, using a didactic presentation as well as hands on animal training in a live porcine model
- Expert in upper gastrointestinal anatomy and pathology, use of a wire guided multi-lumen catheter system for an implanted medical device
- Investigated complaints and examined returned malfunctioning product for defects and flaws for reports
- Continue to support Research and Development with In-Vivo GLP porcine studies and product improvements
- Worked with external companies on prototype products with hemostatic and antibacterial coatings
- Completed Solid Works essentials course by CADD Edge
Research Associate
GI Dynamics, Inc.
01.2012 - 01.2015
- Developed and tested parts for new catheter delivery and retrieval system prototypes, and improved functionality of existing catheter system
- Experience with pebax and nylon extrusion, Nitinol coated wires, and bonding leur fittings and legs to designed molded parts
- Created new anchoring device prototypes, using Nitinol and ePTFE material
- Wrote protocols and reports for engineering studies including animal studies and product testing, involved with design control procedures (SRA’s, FMEA’s, Validation) through all design phases of product development
- Organized and conducted laboratory procedures and studies based on protocols derived from engineering on porcine and canine models, and performed tissue dissection and pathology; IACUC trained
- Investigated complaints and examined returned malfunctioning product for defects and flaws for reports
- Patents: US20160206458A1 (Atraumatic gastrointestinal anchor, and delivery and retrieval systems for same), US20180028339A1 (Devices and methods for placing a gastrointestinal device), WO2017132679A8 (Gastrointestinal delivery systems and methods)
- International physician trainer, using a didactic presentation as well as hands on animal training in a live porcine model
Education
B.S. - Biology
Northeastern University
01.2011
Skills
- Philips Six Sigma Green Belt Training
- Visio
- Minitab Experience
- Solidworks 3D CAD Design Software
- Bluehill Instron Tensile Tester Software and Testing
- Quality System and Design Controls Experience
- Animal Laboratory Procedures
- Physician Education Experience
- Microsoft Office
- Microsoft Project
- SAP
- Pattern and trend analysis
- Cross-functional teamwork
- Innovative thinking
- Data assessments
- Validation testing
- Scientific writing
Extracurricular Activities
Seacoast United Soccer Coach, 2022, Current Londonderry Soccer Club Coach, 2018, 2024 High School Girls Varsity Soccer Head Coach, 2016, 2018 Academy of Notre Dame Soccer Camp Director, 2016, 2017 High School Boys Junior Varsity Soccer Head Coach, 2011, 2015
Timeline
Senior Risk Management Quality Engineer
Philips Healthcare
12.2024 - Current
Risk Management Quality Engineer
Philips Healthcare
04.2020 - 12.2024
EU MDR Quality Specialist
Philips Healthcare
03.2019 - 04.2020
R&D Engineering Consultant
Instylla, Inc.
05.2017 - 12.2017
R&D Consultant
Endobetes, Inc.
01.2016 - 09.2022
Clinical Engineering Specialist
GI Dynamics, Inc.
01.2015 - 08.2015
Research Associate
GI Dynamics, Inc.
01.2012 - 01.2015
B.S. - Biology
Northeastern University
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