Team

Marc Orloff

Consultant

Marc Orloff is an accomplished, solutions-oriented, product development professional with 25 years of experience in facilitating medical device and combination product development from concept through production.  Marc is a highly adept problem solver, skilled at defining the core nature of issues, identifying and analyzing root causes, and detecting waste elimination opportunities.  A proven leader recognized for program management skills and technical proficiency in systems engineering and design and development processes.  A highly motivated manager with the strong ability to cross-function as a team member, leader and independent professional performing under pressure to meet deadlines even under challenging circumstances. Marc excels at turning individuals into teams that work efficiently and exceed expectations.  

Academic & Professional Qualifications:
  • Bachelor of Science – Mechanical Engineering, University of Buffalo
Training / Quality Systems / Specialties:
  • Cross-functional / multisite team leadership and program management
  • Systems Engineering
  • FDA cGMP/QSR quality management systems and development processes
  • Design and development of FDA 510(k) and -marked compliant medical device and combination products
  • Staff coaching, mentoring and leadership
  • Tradeoff analysis and decision making
  • Mechanical Engineering
  • 3D parametric modeling (Solidworks)
  • Design for Six Sigma