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Duane Herberg is listed as Director of Software Medical Device Quality Assurance, Regulatory, and DevOps | Regulatory compliance for FDA, ISO, and IEC | SaMD, SiMD, AI/ML, Cybersecurity | PMP, PMI-ACP | "Building a Better Foundation for Software" at 23andMe, based in San Francisco Bay Area, United States, United States. AeroLeads shows a work email signal at 23andme.com and a matched LinkedIn profile for Duane Herberg.
Duane Herberg previously worked as Senior Program Manager - Medical Device Quality Assurance at 23Andme and QMS Expert / Project Manager / Agile Coach (Consultant) at Ventana Medical Systems. Duane Herberg holds Bachelor Of Science (B.S.), Physics from Winona State University.
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My motto is "Building a Better Foundation for Software”. Great medical device software is built on a foundation of core software practices including Quality Management, Project Management, Configuration Management, Requirements Management, Risk Management, Security, and Development Operations (DevOps). I'm dedicated to establishing and continuously improving these core competencies to enable repeatable, cost-effective delivery of high-quality software products. My leadership and expert knowledge have been key in moving companies and products from startup to market leadership positions.I envision and build efficient and compliant quality management systems for international requirements including FDA 21 CFR, IEC 62304, IEC 82304, ISO 13485, ISO 14971, ISO 27001, MDCG, MDD, MDR, and IVDR.My experience and expertise spans the entire life cycle of medical devices from premarket submissions to postmarket surveillance, across a variety of software architectures from embedded to Software as a Medical Device (SaMD) and cloud computing. I’ve been hands-on with implementation and coaching of leading-edge quality assurance and project management techniques including Agile, Risk Management (Project and Product), Earned Value Analysis, CI/CD, and Automated Test.When I'm not thinking about medical device process improvement, you might find me trying to engage body as well as mind by dancing with my wife, curling, or just walking the dogs.
Listed skills include Fda, Quality Assurance, Medical Devices, V&V, and 45 others.
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A career timeline built from the work history available for this profile.
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.
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.
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.
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.
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.
Other employees you can reach at 23andme.com. View company contacts →
Germaine Fuh
Colleague at 23Andme
Pacifica, California, United States, United States
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Erin Conghuyen
Colleague at 23Andme
Irvine, California, United States, United States
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Robin Free Fire Live
Colleague at 23Andme
Dhaka, Dhaka, Bangladesh, Bangladesh
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Michael Morales
Colleague at 23Andme
San Francisco Bay Area, United States
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Rainy Lu
Colleague at 23Andme
San Francisco Bay Area, United States
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Michal Pawlowski
Colleague at 23Andme
Warsaw, Mazowieckie, Poland, Poland
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Callie Coto
Colleague at 23Andme
Sunnyvale, California, United States, United States
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Anne Wojcicki
Colleague at 23Andme
Mountain View, California, United States, United States
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Emily Weinstein
Colleague at 23Andme
United States, United States
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Daryl Leung
Colleague at 23Andme
Palo Alto, California, United States, United States
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Quick answers generated from the profile data available on this page.
Duane Herberg works for 23andMe.
Duane Herberg is listed as Director of Software Medical Device Quality Assurance, Regulatory, and DevOps | Regulatory compliance for FDA, ISO, and IEC | SaMD, SiMD, AI/ML, Cybersecurity | PMP, PMI-ACP | "Building a Better Foundation for Software" at 23andMe.
AeroLeads has found 1 work email signal at @23andme.com for Duane Herberg at 23andMe.
Duane Herberg is based in San Francisco Bay Area, United States, United States while working with 23andMe.
Duane Herberg has worked for 23Andme, Ventana Medical Systems, Novartis Consumer Health, St. Jude Medical, and Endocardial Solutions.
Duane Herberg's colleagues at 23andMe include Germaine Fuh, Erin Conghuyen, Robin Free Fire Live, Michael Morales, and Rainy Lu.
You can use AeroLeads to view verified contact signals for Duane Herberg at 23andMe, including work email, phone, and LinkedIn data when available.
Duane Herberg holds Bachelor Of Science (B.S.), Physics from Winona State University.
Duane Herberg is listed with skills including Fda, Quality Assurance, Medical Devices, V&V, Testing, Validation, Iso 13485, and Quality System.
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