Tom Grey Email & Phone Number

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.

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.).

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.

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.

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.

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.

Ms, Biomedical Engineering

2Nd Bs, Electrical And Electronic Engineering

Bs, Human Biology (Honors, Minor Chemistry)