Hillsborough, NJ 08844
Summary of qualifications
Technically versatile self-starter with years experience in the electronic medical device field. Small and large company backgrounds allowed for experience in all aspects of product realization from idea to market.
Design and Development Management: Ability to successfully manage medical device design process utilizing FDA and ISO13485 Design Controls and appropriate documentation; development plans, time and budget studies, risk analysis, design reviews, hardware, software, and device verification/validation.
Electronics Designer: Solid experience in circuit design including microprocessors and microcontrollers, real time firmware development, digital logic, analog, op-amps, instrumentation amps, A/D, D/A, isolation techniques, ESD/EMI mitigation, and printed circuit board design using CAD tools. Experienced with all types of electronic test equipment: multimeters, oscilloscopes, power supplies, frequency and function generators, emulators, etc.
Manufacturing: Experienced in product and contract manufacturing. Capable of transferring design to manufacturing, set up process flows, manufacturing technical documentation and test and work procedures, BOMs, DMRs, employee training, production costing and estimating. Knowledge of IPC 610. Performed root cause analysis of returned field instruments.
Quality Assurance: Working knowledge of FDA cGMPs and QSR, ISO13485, product and assembly test, failure analysis, customer complaints review and resolution, CAPA, ISO14971, IEEE software development standards. Design tests and protocols for device acceptance, life testing, and safety. Performed device, software, and equipment verification and validation.
Regulatory: Knowledgeable in FDA device product approval processes via 510Ks. Proficient experience with many national and international medical and safety standards (IEC60601 and collaterals) and performance requirements and can apply those successfully to product design, development, testing/qualification and manufacturing. Prepared technical files for 510Ks, UL Listings, CE certification, and safety and EMC testing submissions. Familiar with RoHS and WEE requirements.
Software: Experienced embedded controller firmware programmer. Assembler (Freescale HC family; 05,08,11) PIC, 8051 families, AVR, Arduino. Experienced with software SOPs, code reviews, Verification/Validation and testing techniques, and required documentation. Languages and software packages include: Assembler, C, Visual Basic, Database programming, SQL, HTML, Ladder Logic, Windows, DOS, Microsoft Office Suite (Word, Excel, Access, PowerPoint, Publisher, Visio, Outlook), Requisite Pro Requirements management, Test Track issue and bug tracking, OrCad, TurboCad, Eagle PCB, Smartdraw, QuickBooks, Code Warrior, ViewMate, WinDaq, DaisyLab, and IHS Component Obsolescent software.
June 2016 to Present ProtoTypes Plus Hillsborough NJ
Consulting Design Engineer
Electronic circuit and product design
Microprocessor software development and programming
Printed circuit board layout
Prototype and small production run assembled circuit boards
August 2015 to May 2016 TEVA Pharmaceuticals Monmouth Junction, NJ
Generic Pharmaceutical and Device Manufacturer
Contract Device Development Engineer Project Leader
Managed contract manufacturer for development of new medical device.
Evaluated and researched ideas for new innovative medical devices to interface to the Internet of Things
May 2011 to November 2014 International Technidyne Corp. Edison, NJ
Manufacturer of Point of Care Blood Analyzers
Manufacturing Engineer III
Design requirements and procedures and construct test fixtures for instruments, assemblies, and components.
Evaluate, source, and test components for instrument RoHS conversion and for obsolete components.
Initiate and perform Engineering Change Orders (ECOs) for instrument products changes, manufacturing improvements, and components.
Perform verification and validation activities for ECOs, manufacturing equipment and processes, and manufacturing equipment software.
Participate in new product requirements development and hazard/risk analysis for new and existing products and the manufacturing thereof.
Performed FMECAs of products and manufacturing processes.
Write technical documentation and reports for all activities.
July 2010 to May 2011 Contract Engineer
Abbott Labs, Manufacturer of Point of Care Blood Analyzers
Performed failure and root cause analysis on field service returns of blood analyzer instruments and worked with the quality and manufacturing departments to initiate and resolve CAPA items.
ProtoTypes Plus, my own company that performed circuit design, layout, and prototype level circuit board assemblies.
April 2009 to July 2010 Angel Medical Systems Shrewsbury, NJ
Manufacturer of Implantable Cardiac Monitoring Devices
Hardware Engineering Manager
Electronic hardware technical lead for new product development.
Generate electrical requirements and specifications for new products.
Select, oversee, and interface with electronic contract manufacturers (EMS).
Interface with Quality and Regulatory departments to perform FMEAs, CAPA, and risk analysis.
March 2008 to April 2009 Johnson & Johnson Ethicon Somerville, NJ
Manufacturer of wound care and women’s health and urology devices
Electrical Staff Engineer, Research and Development
Technical staff member for new product development on two of the company’s line of electromechanical surgical products. This included working with teams to develop and document product requirements and the design specifications, selecting and interfacing with contract design and manufacturing facilities, and organizing internal and external resources required.
Worked with QA and Regulatory departments to investigate and rectify product CAPA items.
Part of a team to evaluate and standardize processes and tools used for the organization’s electromechanical product and software development in order to consistently design safe and effective products while meeting national and international regulations and standards.
March 1995 to January 2007 NeuMed Inc., Neurotron Medical Trenton, NJ
Private Medical Device Manufacturer, Handheld Nerve Conduction Monitoring Equipment and Accessories
Product Development Engineering Manager
Upon hiring, set up company’s complete manufacturing facility that I managed and continued to oversee for over ten years. This included setting up work areas, purchasing all equipment, hiring employees, instituting operational processes and procedures and business practices required for a small manufacturing operation.
As Product Development Engineering Manager, responsible for the design, development and project management of the company’s line of Nerve Conduction Monitoring equipment.
Worked with the marketing department to analyze and evaluate new product ideas for design and manufacturability. Created budget and time schedules for projects.
Interfaced with physicians and other medical professionals concerning design features and ideas, patient testing protocols, operations, and troubleshooting.
Performed design changes per marketing and quality improvement recommendations.
Performed Hazard/Risk Analysis on new device designs and device changes and modifications.
Established and performed device verification and validation studies. This included both hardware and software verification/validation as well as working with contract companies to perform regulatory testing per international safety requirements such as the line of IEC601 and EMC standards.
Maintained and controlled company technical and product documentation. Instituted and approved all Engineering Change Orders.
Designed prototype circuit boards for design evaluation using PCB layout software. Tested, evaluated, and documented prototype designs. Designed, constructed, and documented custom test equipment for product testing and QA.
Established relations and interfaced with various vendor types for circuit boards, packaging requirements, components, custom parts, regulatory testing, etc.
Tested and analyzed circuit and component failures for investigating trend analysis and improving quality. Worked with manufacturing departments and subcontractors to rectify problems.
Oversee manufacturing operations and liaison with contract manufacturers and custom component suppliers.
Interfaced with FDA personnel during regular establishment GMP/QSIT inspections.
Fairleigh Dickinson University Teaneck, NJ
Bachelor of Science, Electrical Engineering Technology
Deans List, Graduated with Honors
Continuing Education: ‘C’ Programming, Visual Basic Programming, Advanced Visual Basic Programming, Database Design and SQL, and DaisyLab. Have attended numerous seminars and training courses relating to FDA Good Manufacturing Practices, Design, and Software control. In addition, regularly attend semiconductor manufacturers’ seminars relating to new products and design techniques to stay current with new technologies and products.