Todd Gilbert Email & Phone Number

San Jose, California, Us

Netanya, Israel, Il

Waltham, Ma, Us

Bad Homburg, Frankfurt, De

This multi-billion-dollar, medical device company produces renal treatment and support products * Transition PCBA manufacturing from OnCore (Fremont) to OnCore (Tijuana), as a cost-saving measure* Bring on second-source PCBA Manufacturer - Jabil (Guadalajara) to mitigate risk* Expand the Cable Manufacturing at Avnet (Ogales, MX) as a cost-saving measure* Add OnCore Interconnect (Tijuana) as a second source for cables to mitigate risk

Perform QMS Audits at domestic and international supplier sites

Danvers, Ma, Us

This multi-million-dollar, medical device company produces catheter-placed hemodynamic support products • Perform Root Cause Corrective Action activities on Automated Controller consoles to minimize patient risk and guarantee product design requirements are maintained

This multi-million-dollar, medical device company produces implantable seizure-management systems to treat Epilepsy• Strategize and Manage complex compliance scenario on Safety, EMC and RTA testing of system consisting of implantable and external components• Modified several product design requirements to align with standards’ needs• Utilize ANSI/AAMI PC69; EN 45502; ISO 14708; ISO 14117; 60950; 60601, 3rd-edition; and FCC/IC/EN Transmitter testing standards to navigate product compliance• Support test labs to meet product compliance and acquire product certification• Compose numerous verification protocols to guide testing• Manage in-house compliance testing by training personnel and overseeing testing

Kalamazoo, Mi, Us

This multi-billion-dollar, medical device company produces patient care, patient handling and temperature management products.• Support new product development by scheduling, managing and executing EMC testing at Stryker Instruments, LECO and TUV• Interact with UL to achieve successful UL file transfer, IPI (initial product inspection) and documentation audits• Primary Approvals representative that assisted with transfer of products from Stryker-purchased Gaymar (Orchard Park, NY); to Jabil (Shanghai, China), and Stryker Instruments (Portage, MI) to ensure continued manufacturing and repair activities are met• Perform Approvals activities to guarantee 60601-1, 2nd Edition compliance on Gaymar products• Confirm legacy product designs are manufacturable by performing complaint investigations, DHF reviews, procedure assessments and MDR reviews• Execute 60601-1 testing on legacy products, to assess compliance to 60601-1, 2nd Edition

This multi-billion-dollar, medical device company produces perfusion devices for use in cardiac bypass surgery.• Acted as Terumo liaison with vendor (Garrett Technologies – Northbrook, IL) which improved timeline efficiency • Reviewed Design History File and identified several document deficiencies• Updated design history documents to ensure they accurately reflect claimed and realized performance• Technical reviewer and engineering consultant on V&V protocol documents, to maximize document accuracy• Mined Design History File (DHF) data from Matrix archive system, to guarantee new document development accuracy• Directed activities to ensure specifications and protocols correctly supported 60601-1 family of standards• Designed and prototyped electrical system used for verification testing• Validated test fixtures to prepare for usage at vendor site, and ensure performance• Tracked project using Telelogic DOORS and Microsoft Project, to maintain traceability and control

This million-dollar, privately-held, VC-funded, medical device, startup company produces a wound healing medical device. • Sole electrical engineer who performed all EE functions including: design, prototyping, project management, resource-management and vendor-liaison activities.• Performed DHF Gap Analysis on legacy system, to establish compliance with 60601-1 3rd edition• Created Trace Matrix and Risk Priority Numbering scheme to document performance expectations• Applied ISO 14971 to assess and establish risk requirements • Managed design activities, to assure project schedule was maintained• Administered resource-management activities, to guarantee product repair schedules were maintained • Designed and prototyped Microchip PIC 18F and Freescale K60 microcontroller-based electrical systems to be used on next-generation product• Analyzed and adapted legacy V&V protocol and DHF risk documentation for next-gen product

Eden Prairie, Mn, Us

This separately-branded, Tennant Corporation, start-up operating-group has developed a system that produces a solution for commercial and industrial cleaning.• Designed and implemented electrical systems on product to shorten time-to-market• Improved programming structure of firmware for NXP LPC2368 microcontroller to ensure product performance• Executed V&V on system to ensure circuit and software functionality • Controlled document revisions using Telelogic DOORs to improve traceability • Performed circuit analysis and debug of micro-controller circuits resulting in improved performance• Coordinated, managed and performed UL 979, EN 61010 and EN 61326 compliance testing at NRTL to ensure performance targets were met

This multi-million-dollar, separately-branded, 3M Corporation operating-group produces traffic management systems.• Monitor Contract Manufacturer performance via site visits and performance metric tracking• Created test protocols to perform reliability testing, and organized the archiving of results• Developed and validated traffic-management product using LabVIEW-controlled tester, shortening its time-to-market• Utilized Altium Designer to facilitate schematic capture and PCB layout electrical design activities, to ensure successful V&V compliance• Involved in redesigning product to minimize its physical size, which resulted in improved performance• Advanced third-party, LabVIEW tester, preparing it for use in manufacturing environment

San Clemente, California, Us

This billion-dollar, publicly-traded medical device company produces medical-grade infusion and syringe pumps for medicine administration.• Visited Watford, UK to perform a DHF EMC Gap Analysis on legacy large-volume pumps using the EN 60601-1 standard, to lengthen product lifespan• Conducted structured complaint investigations to identify and correct performance deficiencies• Member of Technical Review Team that defined product life cycle testing expectations and directed-activities • Prepared testing protocols and reported on results of field return issues• Used Telelogic DOORS to create specification documents and manage revisions on new product development• Applied ISO 14971 standard to address Risk Management issues and create performance attributes• Devised creative methods to assist in evaluating returned infusion pumps, to successfully recreate failures observed in the field• Utilized Design Input documents (DID) to assess performance on field returns• Used pareto charting method to demonstrate historical performance trending results and guide activities • Created an embedded Assembly/C utility to mine pump Error Code data on a Motorola 68HC11 microcontroller; which was used to assist in Root Cause Corrective Actions (RCCA) on returned products, and development of an alternate methodology to program pump software for manufacturing• Reviewed DHF, and performed associated QA activities to sustain legacy products• Utilized Environmental Stress Screening (ESS) tools to recreate field errors on returned products• Performed electrical simulations using PSPICE and ngspice to accelerate circuit development• Involved in selection of a 3rd party electrical design company to advance departmental profitability• Defined Preventive Maintenance procedures to insure product integrity in manufacturing• Utilized OrCAD to redesign systems to overcome obsolescence and performance issues and prolong product life