Tom Grey

Tom Grey Email and Phone Number

Engineering & management professional with Product Development, Operations, QA, and IP experience. @
Tom Grey's Location
Central Point, Oregon, United States, United States
Tom Grey's Contact Details

Tom Grey personal email

n/a
About Tom Grey

Results focused electronics engineer and technical manager with industrial, commercial and medical device (including disposables) experience. Hands-on specialist in product development (requirements, analog/digital, embedded, mechanical, optical, verification/validation), project/program management, operations (in-house and contract manufacturing, sustaining engineering), patents, quality systems (FDA, ISO, design controls), regulatory affairs (510(k)s, regulations), and risk management.

Tom Grey's Current Company Details
Grey Biomedical

Grey Biomedical

Engineering & management professional with Product Development, Operations, QA, and IP experience.
Tom Grey Work Experience Details
  • Grey Biomedical
    Principal
    Grey Biomedical Apr 2014 - Present
    San Marcos, Ca And Central Point, Or
    Engineering consultant. Current projects include: product development, analog/digital circuit design (PADS Logic and Layout), firmware, system design, IIOT strategy and implementation, testing, operations support (strategy, in-house SMT and assembly, sustaining), and process improvements (software development, document control, project management) for an established industrial controls company; intellectual property and technology consultation for an established technology company.Completed projects: enterprise labeling solution (Loftware coupled to Oracle) system design, project management and interim QA Director for an established medical device company, product development and electrode design support for startup medical device company.
  • Watt Stopper/Legrand
    Director, Engineering
    Watt Stopper/Legrand Oct 2008 - Sep 2013
    Carlsbad, California
    Managed product development, project management and intellectual property activities. Developed/managed annual department budget (staff, R&D, CAPEX), controlled costs. Supervised engineers, engineering managers (electronics/firmware, mechanical, test, advanced manufacturing, sustaining, document control, technical writing) and admin staff, managed facility. Performed project/program management, design/sustaining engineering, design reviews, change control, failure investigations. Dozens of released products. Multiple patents filed/issued. Worked closely with Marketing, Quality Assurance and Operations over full product lifecycle (concept, development, release to production (China manufacturing), in-market sustaining, end of life). Drove process improvements and sustainability efforts. Managed regulatory (FDA, FTC, RoHS, conflict minerals, etc.).
  • Invuity Inc
    Vp Operations / Advanced Technology
    Invuity Inc Mar 2005 - Sep 2008
    San Marcos And San Francisco, California
    Early employee at start up medical device company, now public (IVTY). Developed novel surgical illumination system incorporating disposable light guides into surgical retractors for spine surgery applications (primarily). Performed design engineering, program/project management and testing. Managed operations, product development, project management, IP, regulatory. Multiple patents filed/issued. Established and maintained quality system. Managed work of outside design consultants (US, Spain), qualified contract manufacturers (China and U.S.) and sterilization (U.S.). Transitioned engineering and operations from San Marcos to San Francisco office in '08 taking Advanced Tech role (R&D, IP) after hiring operations replacement.
  • Grey Biomedical
    Principal
    Grey Biomedical Apr 2003 - Mar 2005
    San Marcos, California
    Product development, operations, quality systems, IP and regulatory consultant. Projects included: manufacturing test software (Visual Basic) for medical device company; 510(k) technical documentation for medical device company; PCB redesign, manufacturability improvement, operations consultation (COGS, supplier management) for security system startup; portable electrogastrogram product and quality system for medical device startup; RFID-based automated attendance system (Visual Basic including server, hand-held operating WinCE, and laptop applications with wired and WiFi communication) for technology startup; surgical illumination system concept and prototype development for medical device startup.
  • Woodside Biomedical
    Vp Operations / Product Development
    Woodside Biomedical Nov 1997 - Jun 2003
    Carlsbad, California
    Developed novel nerve stimulation medical device for treatment of nausea and vomiting (prescription and OTC consumer products). Transitioned Operations to another VP after moving northern California operations to southern California mid '98. Managed product development, budget, patents. Managed outside design consultants. Implemented original quality system, assisted QA and Operations off-shore manufacturing (Malaysia, China), performed circuit design, PCB layout, phase gate design reviews, project management, test and sustaining activities, performed risk management (14971, FMEA), member audit team (FDA, ISO, internal). Multiple patents filed/issued. Participated in regulatory affairs with outside consultant, personally achieved over-the-counter approval for pregnancy opening new market. Company sold to Abbott Labs.
  • Maven Laboratories
    Director / Vp Operations
    Maven Laboratories Jun 1993 - Oct 1997
    Sacramento, California Area
    Started as Operations consultant in June 1993, progressively increasing involvement and responsibilities, went full time as Director June 1996, then VP March 1997. Established operations facility (light manufacturing, warehouse, offices, IT, China contract manufacturing), wrote financial P&L database/reporting (Access). Implemented quality system (FDA, ISO9001). Participated in regulatory affairs. Managed IP. Company was restarted as Woodside Biomedical.

Tom Grey Skills

Product Development Medical Devices Engineering Electronics Manufacturing Quality System Product Management Fda Cross Functional Team Leadership Testing Design Control R&d Iso 13485 Embedded Systems Quality Assurance Operations Engineering Management Firmware Project Management Program Management Fmea Design For Manufacturing Pcb Design Process Improvement Start Ups Budgets

Tom Grey Education Details

Frequently Asked Questions about Tom Grey

What company does Tom Grey work for?

Tom Grey works for Grey Biomedical

What is Tom Grey's role at the current company?

Tom Grey's current role is Engineering & management professional with Product Development, Operations, QA, and IP experience..

What is Tom Grey's email address?

Tom Grey's email address is to****@****ink.net

What schools did Tom Grey attend?

Tom Grey attended California State University-Sacramento, California State University-Sacramento, California State University-Sacramento.

What skills is Tom Grey known for?

Tom Grey has skills like Product Development, Medical Devices, Engineering, Electronics, Manufacturing, Quality System, Product Management, Fda, Cross Functional Team Leadership, Testing, Design Control, R&d.

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