Medical Technologies Mechanical Engineer/Manager.

DAVRON CV: Candidate 1886196

MECHANICAL ENGINEER | R&D & REGULATORY | MEDICAL DEVICE PRODUCT DEVELOPMENT

Core Expertise

• Regulatory submissions and FDA interactions for Class II medical devices including 510(k) strategy and execution.
• R&D leadership delivering product development from concept through market clearance on high-priority programs.
• Sterility assurance and test method development used across multi-hundred-million-dollar product platforms.
• Risk management, DFMEA and UFMEA creation, and validation planning for molding and assembly processes.
• Mechanical design for constrained packaging; crash-resistant bladder systems for aerospace and automotive applications.

Project Background

• Led cross-functional team to obtain first 510(k) clearance in 25 years, protecting roughly $300M in revenue.
• Developed sterility assurance test collaborating with FDA, internal SMEs, and external labs; adopted across $500M platform.
• Created integrated project plans with clear deliverables and milestones, enabling accurate and predictable schedules.
• Authored risk management files and executed IQ/OQ/PQ validations with suppliers for wearable injector projects.
• Designed test tooling, fixtures, and MSAs; managed endurance and functional testing for new product validation.

Key Skills

• SolidWorks | 3D CAD
• 510(k) submissions | FDA interactions | regulatory strategy
• Sterility assurance | Test method development | Laboratory collaboration
• IQ/OQ/PQ | MSA | validation planning
• Risk management | DFMEA | UFMEA
• Project management | Integrated project planning | Cross-functional leadership
• Root cause analysis | Complaint handling | Supplier validation

Education

• B.E., Mechanical Engineering — Stevens Institute of Technology

Why Interview this Candidate?

Brings 14+ years of mechanical engineering experience in medical device R&D, regulatory submissions, and test development. Led cross-functional teams to secure high-value 510(k) clearance and delivered sterility assurance methods deployed across large product platforms. Proven ability to create integrated plans, mentor engineers, and execute validation programs, making them an immediate asset for regulated product development teams.