Tom Papanek

About Tom Papanek

People and project leader with deep background in medical devices, factory automation, optics and photonics, analytical instruments, dental devices, bio-tech, and semiconductor equipment. Demonstrated ability to generate international revenue growth with products from concept to manufacturing and market launch. Comfortable working both at the strategic business level and hands-on in the lab and production floor. Effective in recruiting, developing, and motivating high performance teams at multiple international locations. Developed and implemented ISO-13485 and FDA QSR compliance.Experience includes: medical devices, automation, market analysis, patent analysis and IP management, ISO-13485, industrial design, product development life-cycle, international manufacturing, finance, product road map, customer-facing contract negotiation, project management, manufacturing, software, thermal systems, electronics, sensors, reliability testing, failure analysis, plastic molding, clean room, FDA GMP and 510(K), clinical trials, merger and acquisition.

Experience

1. Vice President Global R & d

   Organ Recovery Systems

   Mar 2021 — Present · Itasca, IL, US

   As Operations and Engineering leader, my teams are responsible for procurement, inventory, contract manufacturing, sterilization, product quality, performance enhancements, and new product development. We\'re proud to produce the LifePort Kidney Transporter and Disposables which are used in the majority of kidney transplant cases in the US and worldwide, and especially proud that we successfully fulfilled the needs of all our clinical users despite global supply chain disruptions during and after the Covid pandemic.

Education

• Massachusetts Institute of Technology

  Master's degree, Mechanical Engineering

  1974 — 1976

• Massachusetts Institute of Technology

  PhD, Mechanical Engineering and Biomedical Engineering

  1976 — 1978

• Columbia University

  BS, Mechanical Engineering

  1970 — 1973

Skills

• Product Design
• Six Sigma
• Product Launch
• 510(K)
• Ul
• Iso-14971
• Quality System
• Medical Device R&D
• Testing
• Cross-Functional Team Leadership
• Patents
• Semiconductor Fabrication
• Engineering Management
• Electronics
• Sensors
• Team Leadership
• Project Management
• Fmea
• Software Development
• Recruiting
• System Design
• Risk Management
• Medical Devices
• Design Control
• Program Management
• Simulations
• Diagnostic Instruments
• Manufacturing Engineering
• Semiconductors
• Strategy
• Industrial Design
• Mechanical Engineering
• Research and Development (R&D)
• Design for Manufacturing
• Contract Negotiation
• Start-Ups
• Innovation
• Ergonomics
• Product Development
• Medical Lighting