Michael Urban

About Michael Urban

Collaborative and results-oriented technical leader with 20+ years of experience in leading multi-disciplinary, global scientific and engineering organizations. Proven track record of building high-performance teams and delivering commercially successful programs on-time with high quality. Accomplished in all aspects of life science and diagnostic device development from feasibility through commercialization and post market surveillance. Hands on executive leadership in design control, quality management, product and security compliance, and global regulatory requirements. Demonstrated capability in delivering complex assay and instrument projects with significant technology and software development in an FDA regulated environment. Exceptional capacity to manage multiple priorities and quickly master new skills and knowledge to deliver results. Capable of building technology-focused teams from the ground up, including highly specialized teams in hardware/optics, artificial intelligence/machine learning, and biology/chemistry for accelerated achievement of project or contract milestones.Specialties: Cross-functional Leadership of Technical Teams, Diagnostic/Medical Devices, Systems Design and Integration, Machine Learning and Algorithms, Software Development Lifecycle, IVD Assay and Reagent Design, Program Management and Government/OEM Contracts, Business Process Optimization, Staffing and Efficiency Improvement in Global Organizations, Change Management and Talent Engagement, Agile and DBS Lean Methodologies, IP Creation and Acquisitions, Partnership and Open Innovation Agreements, Process Scale-up and Transfer to Manufacturing, Value Engineering and On-Market Product Technical Support

Experience

1. Director of Engineering

   Beckman Coulter Diagnostics

   Aug 2022 — Present · San Francisco, CA, US

   At Beckman Coulter Diagnostics, a Danaher Company, we are committed to advancing health care for every person by applying the power of science, technology and the passion and creativity of our teams to enhance the diagnostic laboratory’s role in improving healthcare outcomes. Ensuring every patient has access to the right antibiotic at the right time is our mission. Responsible for the strategic leadership of the research and development engineering organization, including: New Product Development, Advanced Technology Feasibility, Sustaining Engineering, and Global Product Technical Support of installed products. Direct experience with management of large development programs with external agencies such as BARDA and OEM/Open Innovation Partners from proposal to milestone achievement- Global leadership and direction over the design, development and launch of assays, reagents, consumables, instruments, and software under strict design controls- Execution of projects incorporating the Danaher Business System (DBS) throughout the product development process to improve quality, delivery, cost, and innovation with industry leading best practices and a continuous improvement mindset- Cross-functional collaboration across highly-distributed teams in R&D, marketing, operations, sales, and field service in North America, Europe, and Asia to commercialize and support regulated diagnostic products and services- Strategic and tactical management of budget and resources to drive On Time Delivery and Quality metrics- Organizational development of diverse R&D departments, including hiring and talent development plans, vendor and partner agreements, execution of strategic organizational initiatives, and management of contract milestones.

Education

• University of Illinois Urbana-Champaign

  Bachelor’s Degree, Biology/Biological Sciences

  1991 — 1995

• University of California, Berkeley

  Doctor of Philosophy (Ph.D.), Department of Molecular and Cell Biology | Neurobiology, Cell & Developmental Biology Divisions

  1996 — 2002

• University of Illinois Urbana-Champaign

  Bachelor’s Degree, Anthropology

  1991 — 1995

• University of California, Berkeley, Haas School of Business

  Certificate, Business Education and Development (BEAD) Executive Program for Bio-Rad, 3rd Cohort

  2008 — 2009

Skills

• Cspo
• Molecular Biology
• Integration
• Medical Devices
• Software Development
• Cell Biology
• R&D
• Reagents
• Life Sciences
• Budget Management
• Cross-Functional Team Leadership
• Dna
• Consumables
• Quality Management
• Iso 9001
• Program Management
• Polymerase Chain Reaction (Pcr)
• Customer Product Training
• Product Development
• Validation
• Biochemistry
• Project Management
• Product Design
• Qpcr
• Testing
• Iso 13485
• Microfluidics
• Assay Development
• Pcr
• Biotechnology
• Protein Purification
• Product Transfer
• Research and Development (R&D)
• Commercialization
• Cross Functional Team Building
• Systems Engineering
• Protein Chemistry
• Real-Time Polymerase Chain Reaction (Qpcr)
• Agile Project Management
• Global Cross-Functional Team Leadership