Brad Gilbertson, PMP

Cell: 925-352-4131 bradg@ TechnoSapiensInc.com

SUMMARY
Dynamic and experienced program manager and systems engineer for medical devices and diagnostics. Knowledgeable across all technical, quality, and business functions required to conceive, develop, launch, and sell technology products.

AREAS OF EXPERTISE
Cross-functional Program Management / PMO Software Management Systems Engineering Quality Systems

PROFESSIONAL HISTORY & SELECTED ACCOMPLISHMENTS

TechnoSapiens, Inc, Danville, CA - Principal Consultant 2009 to present
Various short projects: Examples: Program management plan for team of ~210 (12 workstreams), for business and organizational strategies and change management, to drive integration of an acquired 5000-person worldwide technology company. Collaborated across workstreams, functions, projects, and companies to acquire planning knowledge and socialize program intentions. Also, planned funding, quality system, management plan roadmap for a medical diagnostic device startup. Audited quality systems for QSR-regulated clients. (May-October 2012) Pacific Pulmonary Supply: Managed development projects and re-engineered SW development lifecycle for a medical equipment and services supplier. Created and managed project plans for enterprise PMO. Trained teams on requirements analysis. (May 2011-April 2012) (Core team ~10, extended team ~25) BD Biosciences: Program management & systems engineering: Defined a new medical device product concept. (Core team ~28, extended team ~100); (March 2009-April 2011). Developed program plans, budgets, schedules. Reported to PMO. Collaborated on $26MM funding package. Managed selection of two design and development partner firms after evaluating 25 candidate companies; also assessed manufacturing outsource candidates. Negotiated customer, system requirements & system designs among 3 business units, plus 2 outsource development companies, unifying fragmented groups into a team. Resolved system requirements and design conflicts between companies and among client organizations. Created long-term product family technology roadmap. Drove ruggedized biosafe and human-factors-driven designs in electronics, optics, image analysis, motion controls, electomechanicals, microfluidics, micromolding and industrial molding, industrial and mechanical design, enclosures, power, reagents and disposables, polymers & thermoplastics, WEEE, REACH, RoHS. Also led development of a biotech research system to support development of future product concepts (optics, controls, biotech, eg reagents, software). Stealth Startup: Elicited customer requirements, then wrote a telecommunications application (for cellular tower systems, a schematic tool drove specification, test planning and execution, instrument controls, and maintenance tracking). (Jan-Feb 2009)

Abbott Hematology, Santa Clara, CA - Program Development Manager

1999 through 2008

Maintained three concurrent roles: Product Development Program Manager, Principal Systems Engineer, Design Control Program Manager. Product development program management (4 programs): Managed concept-to-launch lifecycle for instrumentation and automation products that incorporated optics, electronics (analog and digital), electromechanical subsystems, fluidics, biotechnology, human factors, software/firmware, RoHS, WEEE, EMC. Managed/released feature updates of CD4000 cytometry system (measurement system hardware and software), plus launched new assay products, including defining and managing budgets, schedules, technology decisions, and product roadmaps (core team ~ 20, extended team ~35). Managed and released feature and reliability system updates (software and control system hardware) to automated Slide Maker/Stainer system, including defining and managing budgets, schedules, technology decisions, and product roadmaps, plus negotiating manufacturing and quality improvements with OEM (core team ~10, extended ~20). Launched new Hematology Lab Automation family; interoperable software, scalable hardware (core team ~35).

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Managed change to introduce a completely new-to-Abbott business model to the company (ie with hardware and software, but no biotechnology product trail). In addition, worked with major laboratories, hospitals, marketing and sales to define customer needs and solutions in large-scale automation, information, and analytics. Also managed certain large-scale product integrations at customer sites, such as Unilab. eQC - data collection and analytics system product for the hematology lab market. Led requirements and designs, managed execution, established data center. Managed change to introduce a new-to-Abbott business model and customer service center requirement, ie a hosted, software-only service (core team about 10, plus partner). General R&D group management: Program management consulting: Guided retirement of a major product, advising manufacturing, purchasing, sustaining engineering, regulatory, marketing, and documentation departments. Planned and managed new facility transition for 153 person R&D group; science & test labs, data center. Continued to lead software PMO function, despite transitioning from software-only management to alltechnology management (business unit had average 8-12 product annual workload, up to 60+ software staff). Worked with executive management to create and maintain 5-year strategic plan. Assessed technical, business, quality capabilities of domestic & offshore technology partner candidates. Principal systems engineer (multiple products) Created a scalable, distributed hardware and software platform architecture and re-usable requirements, for control and human interface systems for a next-generation diagnostic instrument family (processors, optical / fluidic / electromechanical measurement systems, robotics, firmware, and software). Architected a new low-cost portable sorter product concept, designed to cut hospital lab operating labor costs by 10%. (RFID, optoelectical sensing, wireless supervisory interfaces, embedded software). Invented simple, unbreakable encoding technology to authenticate disposables (eg reagent kits) for instruments. (cryptography, barcode symbologies, electromechanical hardware). Drove technology decisions & managed offshore partners for Division Lab Automation & Informatics. Managed integrations on-site for certain important customers, such as University of Virginia Medical Center. Reduced requirements-phase defects by up to 90%, depending on product line, by consulting to product teams on show-stopper problems with requirements, human factors, and traceability while improving efficiency across instrument system product lines. Created R&D systems engineering process and a specialized new product requirements engineering group. Introduced re-usable system requirements, HW & SW subsystem designs, and software code and tests across multiple product lines. Standardized characterization practices and certain critical requirements (eg patient-result-sample linkage). In one year, led 100+ technical reviews to teach engineering practitioners to recognize and define critical quality attributes, preventing at least 3 major product component recalls (estimated $1MM-$3MM each). Consulting within Abbott: Enabled three big-customer automation sales deals (eg $20MM deal with a hospital IDN), and various smaller deals, by intervening to clarify customer needs, build customer confidence, define change management, and scope solutions with hospital IT departments and operations groups. Identified a business capability gap and enabled a new $60MM business by creating a systems sales engagement process that reduced dependence on technical experts. Helped mastermind a new-to-Abbott business model that included a consulting service revenue center and configuration-based cost accounting for in-licensed software. Business process program management & organizational change management (core team ~20-30, extended ~50) Improved Quality System and compliance: Led Six Sigma investigations and managed a multi-year quality program comprising several concurrent and serial process improvement projects and associated change management. Examples: Re-engineered Product Development Lifecycle and Design Control processes for 450-person business unit, trained 135 staff, led cross-functional change management. Closed 50+ major quality cases (CAPAs) in one year, via Six Sigma investigations, and critical process changes, impacting entire product lifecycle. Eliminated nearly all paper records during engineering activities by leading development, integration, introduction, deployment, and change management for: MatrixOne Product Lifecycle Management,

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manufacturing records and engineering records, and cross-functional integrated management of defects, technical review actions, risks, requirements-to-part-spec trace. Led Program to re-engineer and automate business unit's Software Development Life Cycle. Led change management for 8 product groups; trained 50+practitioners on SDLC. Cut software build-and-regress from 2 days to 1-2 hours. Enabled 100% living traceability for requirements and risks, across product lines, while increasing overall efficiency and decreasing defects (Linux, .NET, C#, C/C++, Java, firmware, TeamTrack). With a team, re-engineered Division Product Lifecycle, Design Control, SDLC, and GMP (FDA Good Manufacturing Practices) processes for a 3000-person, $5B division; managed organizational change.

Abbott Hematology, Santa Clara, CA - Software Manager

1993 through 1999

Turned around a $20MM IVD instrument system software development project, and launched the system, which contained human interfaces, seven types of control systems, a supervisory system, data management, and fault-tolerant autonomous communications (Linux/Unix, C/C++, firmware, Tcl/Tk, Motif, Sammi, other software, localization). Change management: Executed the business first large-scale product internationalization and ISO certification (Tick-IT) efforts. Introduced technical approaches (eg object mocking, test driver frameworks, ALM), Agile practices, project support systems and practices. Created the company's first CMM Level 3 software organization (50+ staff), and the first matrix management capability. Managed multiple simultaneous products & projects; introduced an iterative and incremental development model to create an Agile environment for the flagship product family. Strategic alliances: Evaluated, selected, and managed domestic and international software technology partners. Strategy: Created technology roadmap for software development environment across multiple product families. Built up a 200 node LAN and supporting software to support test labs, validation efforts, deployment capabilities, etc. Created and led a software project management office (PMO) to increase capability maturity (core team 52, ext ~60).

Software Associates, San Ramon, CA - Principal Consultant

Prior to 8/1993

Managed client software development and hardware/software systems integration projects of 2-30 staff. Designed systems, engineered business processes. Multiple project turnarounds, organizational designs, and business change initiatives (eg new enterprise systems, new development process, and transition to new corporate facility). Example technologies: Real-time controls (temperature, pressure, vacuum, motion controls, manipulators, vehicle sensing, motors, actuators, etc), automated supervision of equipment and mechanical or chemical processes, data communications, custom operating systems, custom programming languages, custom high-performance database management systems, enterprise applications. Example industries: Medical diagnostics, semiconductors, factory automation, telecommunications network management, microwave, equipment supervision & controls, automated test engineering, freight company and airline logistics, hospital management, cable TV.

EDUCATION
St. Marys College of California: BA Management Cal State Univ Hayward: upper division undergrad work in Computer Science, Info Systems Management, Accounting

TRAINING / COURSES
As trainer Offered lectures and training in-company: Design Transfer, Product Lifecycle Management, Software Development Lifecycle, Configuration Management, Medical Device Product Realization To clients, and to industry ( e.g. IQPC SW Development Conference series): Requirements Management for Medical Devices, Driving V&V, Design Control, Risk Management As trainee 2011: PMP certification 2008: Six Sigma Investigators Toolkit 2007: AAMI certificates: Risk Management ISO 14971, Quality System Regulation, and ISO 13485 2006: Business Process Analysis & Development with Matrix One PLM; 2006: DMAIC refresher 2004: Human Factors in Medical Devices, Human Factors in Risk Analysis 2003: QASNA: ISO 9001 Lead Auditor with Tick-IT (SW auditor) certification ASQ & other: QSIT Audit Method, OO SW Engineering With UML, Technical Review Methods