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David Hirning

Sr Principal Human Factors Engineer
  • Suggested rate
    On-demand
  • Experience15+ years
  • Response rate100%
  • Response time1 hour
The project will begin once you accept David's quote.
Location and workplace preferences
Location
San Diego, CA, United States of America
Can work onsite in your office in
  • and around San Diego (up to 50km)
Verifications
Verified email
Languages
Categories
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Skill set
Experience
  • Battelle
    Director, Medical Device Solutions New Product Development | Senior Principal Human Factors SME
    September 2022 - Today (2 years and 5 months)
    Columbus, OH, USA

    - Responsible for strategic planning and operational activities for the New Product Development and User Research division
    - Manage financial performance driving profitability through strategic cost control and judicious investment decisions
    - Lead 35 mechanical engineers, electrical engineers, software engineers, systems engineers, and human centered design engineers, scientists, and designers providing global solutions
    - Provide guidance and mentorship inspiring a culture of thought leadership, innovation and excellence
    - Champion User Centered Design principles based in user research and product management strategy across Battelle to minimize project rework and schedule delays
    - Ensure all design and development activities adhere to established corporate ethics, safety, and ISO 13485 quality system requirements
    - Demonstrate extensive communication, writing, presentation, and research skills delivering multiple presentations, white papers, and journal manuscripts
  • Amgen
    Principal Human Factors Engineer
    April 2022 - September 2022 (5 months)
    Thousand Oaks, CA, USA

    - Fostered strong collaborations with internal and external stakeholders across various functions including engineering, design, commercial, quality, and regulatory
    - Championed HFE/UE/UX/UI user research best practices to fully adhere to current US and EU regulations and guidelines across the medical device, combination product, and biopharmaceutical industries
    - Applied user centered design principles to create innovative and intuitive combination devices, delivering user-friendly solutions that met both user needs and regulatory standards
    - Designed and conducted comprehensive user research studies using robust methodologies, precise data collection, and thorough root cause analysis to support federal and international regulatory submissions
    - Ensured adherence to schedule and budget constraints
  • Medtronic
    Principal Human Factors Engineer
    May 2020 - April 2022 (1 year and 11 months)
    Minneapolis, MN, USA

    - Focused on neuromodulation products, including the implanted targeted drug delivery pump, implanted neuromodulation products, the Electronic Patient Manuals (eManuals), and managing over 20 legacy product submissions for European Union Medical Device Regulation (EU MDR) compliance
    - Conducted multiple usability studies
    - Actively collaborated with systems, software, support, and risk engineers throughout the development process, resulting in an optimized human machine interface, comprehensive user support, and effective training materials
    - The Patient eManuals project underscores my product management expertise in leveraging human factors research, UX/UI methodologies, and advanced techniques to design a comprehensive human-machine system from concept to launch. This process involved integrating creative user research, diverse methodologies, multiple prototypes, and innovative product strategies, culminating in FDA marketing approval
    - Conducted meticulous user research and root cause analysis to guide decision-making and ensure compliance with federal and international regulatory requirements, leading to a successful product release
    - Designed and executed comprehensive user research and data analysis which led to robust solutions that improved UI design and ensured adherence to schedule and budget constraints
    - Facilitated the onboarding of new team members and collaborated closely with program leadership to ensure alignment of project budgets, timelines, and deliverables
    - Demonstrated extensive writing, research, and analytical skills delivering detailed documentation throughout the product lifecycle, ensuring compliance with US/EU regulations, and Medtronic Quality System
Recommendations
Education
  • Master of Science
    Azusa Pacific University
    1997
    Master of Science (M.S.), Computer Science
  • Music Education, Voice and Opera
    Azusa Pacific University
    1994
    Music Education, Voice and Opera