Duane Herberg

Senior Program Manager - Medical Device at 23andMe
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Contact Information
us****@****om
(386) 825-5501
Location
San Francisco Bay Area

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5.0

/5.0
/ Based on 2 ratings
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Dat Nguyen

Duane inspires people to provide the right and affordable solutions for the job. He hired me at St Jude Medical at the right time and at the right place. He had long a vision for test automation and had the package ready for the plan; when he found me, the right person for the job, he entrusted me to carry out the plan, and the rest is history. Now, test automation is a well established process at St Jude Medical, and Duane was the one who directed me to start it all.

Mahesh Veena

To write a complete recommendation about Duane would take up a lot of space. I will try to do my best with the short space that is available. Analytical Abilities: Duane has extremely good analytical skills. He is a very technical person. So he has the ability to dig deep down and understand the technical content of a problem or discussion. At the same time he also has the ability to look at things from a big picture point of view and not get get bogged down by details. Thus he becomes a great resource to consult irrespective of the type of help needed from him. He always thinks about the root cause of a problem and then tries to solve that rather than come up with temporary superficial solutions. Process and Commitment to Quality: Duane is very process oriented. He also constantly thinks about process improvement. He has a very practical approach to dealing with problems regarding processes. His approach to process is that he wants to make the process do the work. Thus the work gets done and at the same time, the process if followed as well. Decision Making: Because of his superior analytical skills, knowledge of process and also his ability to always keep the end goal of a task in mind, he can be decisive when it comes to making decisions. He can think, analyze and make quick decisions. His decisions always have a sound reasoning behind them. While most of us try to stay one step ahead, he easily stays at least three steps ahead in anticipating future consequences of taking certain decisions and thus takes much better decisions. Duane is also very receptive to ideas and approaches to problem solving from other people. He is very collaborative in his work and thus it is an absolute pleasure to work with him. I have personally learned a lot from watching him and hearing him explain when taking quick and sound decisions. Communication Style: Duane is very approachable. His door is always open for anyone to talk to him. His communication is clear, direct and unambiguous. He also listens to others when they are trying to communicate and tries to understand what other people are trying to say. Mentoring: Duane also helps his teams members develop their skills and advance in their professional careers. He takes great interest in mentoring his team members and is very interested in knowing about each person's goals and tries very hard to help each team member get closer to having satisfying careers. He is also very fair while interacting with his team members. It was a great pleasure to work with Duane and it was very educational as well. He can be a great resource for any team.

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Credentials

  • Chapter Leader 2022
    Project Management Institute
    Dec, 2022
    - Nov, 2024
  • PMI Agile Certified Practitioner (PMI-ACP)®
    Project Management Institute
    Dec, 2018
    - Nov, 2024
  • Project Management Professional (PMP)
    Project Management Institute
    May, 2018
    - Nov, 2024
  • Certified Advanced Level Test Manager
    ISTQB - International Software Testing Qualifications Board

Experience

    • United States
    • Biotechnology Research
    • 400 - 500 Employee
    • Senior Program Manager - Medical Device
      • Jul 2018 - Present

      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: - successful international medical device product launches in the US, Canada, and the EU. - an on-site FDA audit (the companies first) with no observations. - initial 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, release 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. Show less

    • United States
    • Biotechnology Research
    • 700 & Above Employee
    • QMS Expert / Project Manager / Agile Coach (Consultant)
      • Jan 2014 - Dec 2017

      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. Show less

    • Switzerland
    • Pharmaceutical Manufacturing
    • 700 & Above Employee
    • Quality Management Systems Expert (Consultant)
      • Jul 2012 - Aug 2013

      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. Show less

    • United States
    • Medical Equipment Manufacturing
    • 700 & Above Employee
    • Senior Director, Software QMS and DevOps
      • Apr 2003 - Sep 2011

      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. Show less

    • Medical Equipment Manufacturing
    • 1 - 100 Employee
    • Technical Lead/Manager, Software Verification and Validation, DevOps
      • Apr 1998 - Apr 2003

      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. Show less

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