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
