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With over a decade spearheading R&D in the medical devices sector, my role amplifies a relentless pursuit of innovation and patient-centric outcomes. My expertise in project management and engineering steers complex Class I & II device developments, from ideation to FDA-compliant market entry. Leading cross-functional teams, our efforts revolve around risk reduction and strategic NPD, ensuring company portfolio continually meets manufacturing site priorities. The passion for my craft and a meticulous attention to detail foster an environment where excellence in healthcare solutions is not just a goal, but a standard.
Fisica, Inc.
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Manager Project ManagementFisica, Inc. Nov 2024 - Present -
Senior R&D Project ManagerPdc - A Brady Business Jul 2017 - Apr 2024Valencia, Ca, UsR&D Project Management & Engineering in the medical devices industry. Risk Reducing New Product Introduction Development of Class I & II Medical Devices - requires 510K FDA & note-to-file. Responsible for managing a portfolio of business-critical projects aligned with the Brady Corp. manufacturing site priorities to ensure continuity of supply. NPD of Class II Medical Devices, this includes 510k submissions and coordinating FDA Note-to-File submissions. Maintain accurate DHF while taking products from concept to design, navigating the design and development process for introducing new products that will have a positive impact on patient experiences. My passion for success is contagious to those around me, I love to inspire others in order to ring out the best in everyone. -
Senior Project Engineer - SustainingVyaire Medical Jan 2006 - Jul 2017Mettawa, Il, Us• Directly lead & manage multiple and parallel projects with cross-functional teams for the sustaining & manufacturing engineering teams, covering all ventilation and diagnostics products (Class II & III Medical Devices), throughout their product lifecycle by hands on data capture, design, development, prototyping (OrCad, Pads, Altium), failure analysis (FA), troubleshooting, component engineering and testing (EMI, EMC, Electrical Safety, RoHS Compliance, HALT…), and PCB / PCBA design changes. • Perform Validation & Verification, Regulatory compliance, design for manufacturability & testability (DFM, DFT), corrective & preventive actions (CAPA, SCAR, NCR), support pilot build\ activities, create and implement Engineering Changes Orders (ECO) across the plant. • Responsible for cost to production savings (continuous improvement process, CIP), that directly led to improved product efficiency, reduce production cost, increase revenue (bottom line) and improve quality of products and process; Lean Six Sigma Green Belt - Certified. -
Senior Sustaining EngineerCarefusion Jun 2006 - Mar 2015San Diego, Ca, Us• Electrical Engineer (BSEE) part of the product sustaining / product engineering group, I support the medical devices systems (Critical Care – Life Support Systems) throughout their life cycle. • Success by hands on research and application of electrical engineering theory and principles, creating requirements, establishing specifications, replacement of obsolete components, PCB layout support, test plans / protocols (EMI, EMC, Electrical Safety,RoHS Compliance, HALT, and Shock and Vibration…), • Verification and validation of the solutions, provide creative and efficient support for current and legacy products, including key obsolescent production issues. • Contribute to and present design reviews with cross-functional teams. Proactive identification, documentation, verification and solutions for release to production by ECO, preventing negative impact to production. -
Sustaining Engineer, Project ManagerCarefusion Jan 2006 - Jun 2010San Diego, Ca, Us• Electrical Engineer (BSEE) part of the product sustaining / product engineering group, I support the medical devices systems (Critical Care – Life Support Systems) throughout their life cycle. • Success by hands on research and application of electrical engineering theory and principles, creating requirements, establishing specifications, replacement of obsolete components, PCB layout support, test plans / protocols (EMI, EMC, Electrical Safety,RoHS Compliance, HALT, and Shock and Vibration…), • Verification and validation of the solutions, provide creative and efficient support for current and legacy products, including key obsolescent production issues. -
Sr. Biomedical Engineering TechnicianCardinal Health Jan 2006 - Jan 2008Dublin, Oh, Us• Provided biomedical technical support to customers on all critical care ventilators / diagnostic equipment. • Troubleshoot, repair, and update customer owned respiratory products. • Lead advanced group training to field service technicians and major hospital biomedical technical staff. • Managed a Lean Six-Sigma 5S inventory control process for factory service department. -
Biomedical Engineering Technician IiViasys Healthcare Jan 2006 - Jan 2007Us• Provided biomedical technical support to customers on all critical care ventilators / diagnostic equipment. • Troubleshoot, repair, and update customer owned respiratory products
Jonathan Lewis Skills
Jonathan Lewis Education Details
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Itt Technical InstituteComputer Electronics Engineering Technology -
Itt Technical InstituteElectrical Engineering & Technology
Frequently Asked Questions about Jonathan Lewis
What company does Jonathan Lewis work for?
Jonathan Lewis works for Fisica, Inc.
What is Jonathan Lewis's role at the current company?
Jonathan Lewis's current role is Project Management Professional Transitioning from Medical Devices to Aerospace – Leading Cross-Industry Innovation and Execution.
What is Jonathan Lewis's email address?
Jonathan Lewis's email address is jo****@****ion.com
What is Jonathan Lewis's direct phone number?
Jonathan Lewis's direct phone number is +190986*****
What schools did Jonathan Lewis attend?
Jonathan Lewis attended Itt Technical Institute, Itt Technical Institute.
What are some of Jonathan Lewis's interests?
Jonathan Lewis has interest in Programming, New Technology, Pcb Design, Education, Organizational Development, Project Managment, Career Growth, Six Sigma Manufacturing, Success Stories, Medical Technology.
What skills is Jonathan Lewis known for?
Jonathan Lewis has skills like Medical Devices, Cross Functional Team Leadership, R&d, Product Development, Engineering, Lean Manufacturing, Design Control, Pcb Design, Biomedical Engineering, Iso 13485, Electrical Engineering, Troubleshooting.
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