Gary Howard Email & Phone Number

Simi Valley, Ca, Us

Founded and grew this boutique consulting firm providing technology advisory and engineering services while positioning the firm as a trusted advisor and strategic partner to clients. Provided advisory, interim executive, and software engineering services while managing project delivery for startups and industry leaders.Reduced project costs by as much as 15% and times by as much as 30% by delivering design control, continuous integration, test automation, validation, Agile adoption guidance, DevOps, and regulatory submission services. Automated design history file generation processes.

San Clemente, California, Us

Directed all facets of New Product Innovation (NPI), sustaining, Cybersecurity, DevOps, and Product Safety whileleading an R&D medical device software organization that implemented numerous embedded infusion systems, desktop systems, and server systems. * Built and led a Software Corrective Action and Preventative Action (CAPA) team that reviewed all product anomalies for the past decade to confirm proper dispensation for this this leading manufacturer of specialty medical devices utilized for infusion therapy, vascular access, and vital care. * Optimized the functionality of embedded software systems by managing the timely replacement of software procedures within the Quality Management System.

Lake Zurich, Illinois, Us

Architected a data acquisition system utilized to test and verify a medical device and validate process tooling at this this global company specializing in lifesaving medicines, infusion technologies for infusion, and clinical nutrition. Led a global I&D organization with systems, software, test, and automation engineering groups that implemented the system and cut testing time >90% by utilizing AWS and advanced automation techniques. Harmonized medical device platforms into a global I&D common software platform utilized by transfusion and infusion business units of the company.* Accelerated product development by championing Agile adoption, validating new development tools, and moving development to the Cloud. * Promoted global partnering opportunities associated with advanced software. Authored and reviewed technical content for 510(k) submission as well as additional Information letters, and 483 inspection observations.

Thousand Oaks, Ca, Us

Guided a cross functional software engineering team that developed an FDA/regulatory strategy to deliver a medical device through the FDA ‘De Novo’ application process for this industry-leading bio tech company. Directed digital health teams that completed proof of concepts, pilots, characterization, and clinical validation studies in the personalized medicine space. * Enabled healthcare professionals to quickly detect hemoglobin levels. Automated project documentation for a medical device that implemented a machine learning algorithm facilitating hemoglobin detection. * Broke new ground in bio tech innovation while accelerating time to market. Designed and established the first-Agile medical device SDLC, configuration management, and risk management procedures.* Reduced testing cycle-times by as much as 80% through automation.* Significantly improved documentation critical to ensuring compliance in a highly regulated industry.

Lake Forest, Il, Us

Retained by Hospira following its spinoff from Abbot Labs in 2004 after having designed and implemented an architecture for a medication management system and securing two patents for inventions developed at Abbot. Directed a global R&D organization while stewarding an eight-figure budget funding capital identification and selection.* Streamlined software development to accelerate product time to market. Created a ‘Software Assembly Line’ utilized to build and test the company’s Symbiq™ infusion pump and the Medication Management System.* Established new departments that streamlined SDLC, automation, and software verification. Reorganized a team of software and test engineers in the US and India to deliver single and dual-channel general infusion pumps.* Reduced product testing and verification cycle times by restructuring two departments that delivered new capabilities across the entire product portfolio.* Enhanced visibility of product development metrics, schedule predictions, and accuracy based on sprint velocity by leading first-ever SCRUM adoption, process, and tooling changes.

Greenwich, Ct, Us

Early career success in consulting and FTE roles involving Computer Programming and Analysis, Systems Analysis, Technical Systems Architecture, Software Architecture, Software Engineering, and Systems Integration. * Co-founded and ran a systems integration company specializing in building and installing real time Supervisory Control and Data Acquisition Systems serving industries including Automotive, water treatment and reclamation, medical device equipment manufacturing, and food processing. Served as trusted advisor to organizations including TRW, J&J Surgical, Orange County, CA Sanitation, and the City of Henderson, * Architected an automated speech recognition system, and an infusion management system. * Co-architected an eCommerce worksite. * Designed and implemented other real time systems including an Application Configuration Utility for distributed process control systems. Designed and built Realtime Views. a product that provided interactive process monitoring. Redesigned a propellant control system and added statistical process control capabilities.* Developed and implemented a Radio Frequency communication utilized to send and collect remote telemetry. Produced a conceptual design for a general-purpose Database Interface (DBI) product.* Improved real time software utilized to analyze atmosphere conditions surrounding a nuclear plant.