Duane Herberg Email & Phone Number

Sunnyvale, California, Us

Leader of the Medical Device Program for Software Engineering - consisting of programs, processes, and projects to efficiently develop safe, effective, and compliant medical devices - with the following major accomplishments:- co-author of first-ever Predetermined Change Control Plan (PCCP) granted by FDA (https://investors.23andme.com/news-releases/news-release-details/23andme-granted-new-fda-clearance-report-additional-brca) - successful IVDR audit with no software findings- successful international medical device product launches in the US, Canada, and the EU- an on-site FDA audit (the companies first) with no observations- ISO 13485 certification plus surveillance audit with only one minor non-conformance- integration of ISO 27001 Cybersecurity procedures with the QMS.Conceived and managed software life cycle process overhauls - including change management, configuration management, verification & validation, risk management, continuous integration, release management, and computer systems validation - resulting in: - reducing effort for change and release management from four FTEs to one, and allowing a daily release cadence. - reducing effort for automated test creation and update by more than 50%. - maintaining unusually high software quality standards.

Tucson, Arizona, Us

Led multiple software teams back from the brink of firefighting, chaotic development to a disciplined Agile development approach, leading to several successful international product launches. Implemented new and improved Agile processes for software estimation and project management, release planning, backlog and issue management, capacity and velocity planning and metrics, scope review, sprint planning and execution, product roadmap planning, and product and project risk management. Managed geographically dispersed teams in the U.S., India, Romania, and Spain.Improved Design Verification and Validation processes in support of regulatory approval for Class II and Class III software, devices, and reagents, Authored Design Verification and Validation plans and System Validation Plans for new product development of automated systems integrating software, electrical, mechanical, reagent, and fluidics sub-systems.

Basel, Baselstadt, Ch

Responsible for Computer Systems Validation (CSV) and cGMP compliance of computer systems used in pharmaceutical operations and quality management systems with special emphasis on risk assessment and electronic records compliance. Engagement resulted in successful restart of a client facility after voluntary shutdown owing to regulatory and quality issues.Managed project teams consisting of client personnel, consultants, and third-party engineering firms to obtain client approval on over 100 validation deliverables including Validation Plans, Risk Assessments, User Requirements, Functional Specifications, Configuration Specifications, Periodic Reviews (gap assessments), Validation Reports, Standard Operating Procedures, and Test Protocols (Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ)). Also, SME and individual contributor.

St. Paul, Minnesota, Us

Author, trainer, and auditor of quality management systems and product development standard operating procedures meeting external regulatory standards for ISO and FDA approvals, including 510k, PMA, project management, release management, requirements management, configuration management, hazard analysis, design review, test planning, text execution, test reporting, backlog management, defect management, and change request management. Built a department of 32 highly skilled direct reports, creating three functional teams (Verification and Validation, DevOps, Computer System Design). Co-founder and member of: Strategic Planning Committee working with divisional President to develop 5-year product road maps; divisional Corrective and Preventative Action Board; divisional Engineering Change Control Board.Significantly reduced costs and issues associated with software manufacturing and field install processes through implementation of a global SaaS software licensing technology which also enabled accurate tracking of software deployed to the field. Initiated and led introduction of Agile development, CI/CD, and automated test methodologies into a waterfall organization, using both Scrum and Kanban techniques, greatly reducing software life cycle effort and time-to-market.

Us

Technical lead and manager of software verification, system validation, and development operations (DevOps) for a start-up medical device company - Endocardial Solutions, Inc. Took breakthrough technology into successful commercial launch. Initiated, planned, and managed the transition of a product line from a very expensive proprietary visualization workstation to commodity PC technology, improving performance and reliability, and saving $20,000 cost-of-goods per unit. This led to a $400,000 cost savings in one quarter, allowing Endocardial Solutions to become profitable, and leading to acquisition by St. Jude Medical.

Bachelor Of Science (B.S.), Physics

Bachelor Of Arts (B.A.), Mathematics