Gary Varshavsky

About Gary Varshavsky

I\'m a strategic engineering leader and systems architect with 20+ years of experience in medical devices and defense. Currently, I lead Sustaining Systems Engineering for an aesthetic laser and energy-based device portfolio, managing a cross-functional R&D team through the full sustaining lifecycle — requirements management, design tradeoffs, EOL solutions, software releases, risk assessments, and regulatory compliance (FDA 21 CFR 820.30, ISO 13485, IEC 62304, IEC 62366).My background spans the full product lifecycle: from De Novo surgical robotic arms and RF Microneedling systems to defense opto-electromechanical platforms and high-performance computing hardware — always at the intersection of systems thinking, cross-functional leadership, and hands-on technical execution. Throughout my career I\'ve led global, international cross-functional teams, bridging engineering, operations, regulatory, and clinical disciplines to deliver complex programs on time and within scope. I hold an M.Sc. in Systems Engineering and a B.Sc. in Mechanical Engineering, and have completed post-academic studies in Drug and Medical Device Development at MIT. Always happy to connect with fellow engineers, innovators, and leaders pushing the boundaries of what medical technology can do.

Experience

1. Sr Manager System Engineering

   Candela Medical

   Oct 2025 — Present · Marlborough, MA, US

   Lead cross-functional R&D engineering teams, collaborating with PMO, Service, Finance, Regulatory, Quality, Operations, and GBUs to deliver design solutions that meet organizational goals and stakeholder expectations for released products.• Provide leadership to internal teams, contractors, and engineering partners.• Apply systems engineering methodologies to manage requirements and ensure compliance throughout the product lifecycle.• Coordinate design, testing, fabrication, and assembly of electro-mechanical systems, laser/RF and light devices• Oversee technical risk assessments and mitigation strategies across design, verification, and test teams.• Collaborating with System V&V and software test leads to defining traceability, test plans, and acceptance criteria.• Manage End-of-Life solutions, replacement candidates, and software releases for performance and bug fixes.• Conduct design and technical reviews across disciplines (electrical, software, mechanical, optical).• Provide periodic sustaining engineering reports, analyzing field complaints, maintenance data, and reliability trends.• Operate within FDA-regulated environments and comply with ISO/IEC standards for Class II medical devices.

Education

• Braude Academic College

  Bachelor of Science (BSc), Mechanical Engineering

  2000 — 2004

• Massachusetts Institute of Technology

  Drug and Medical device development professional, Medical Device development

• Air force Engineering College

  Technician, Aeronautical/Aerospace Engineering Technology/Technician

  1995 — 1996

• Afeka Tel Aviv Academic College of Engineering

  Master of Science (MSc), System Engineering

  2010 — 2012

Skills

• Design of Experiments
• Manufacturing
• Cad
• Autodesk Inventor
• Matlab
• Medical Devices
• Pcb Design
• Quality System
• Product Lifecycle Management
• Geometric Dimensioning & Tolerancing
• Rapid Prototyping
• Mechanical Engineering
• Testing
• Opto-Mechanics
• Pcb Design (Idf)
• R&D
• Ptc Creo
• Project Management
• Solidworks
• Finite Element Analysis
• Sheet Metal
• Injection Molding
• Plastics
• Validation
• System Design
• Inventor
• Engineering
• Engineering Management
• Automation
• Pdm
• Design for Manufacturing
• Electronics
• Pro Engineer
• Systems Engineering
• Systems Design
• Product Management
• Opto-Mechanical Design
• Product Design
• Gd&T
• Product Development