Education
- BS in Mechanical Engineering, Johns Hopkins University
Interests / Obsessions
- Camping and just being underneath a big open sky
- Trampolines, they are still fun as an adult
- Traveling to new places, exploring, and learning about other cultures
- Rhinoceroses, they are my favorite!
Favorite Quote
“Sometimes the questions are complicated, and the answers are simple.”
– Dr. Seuss
Expertise
- Designing and verification testing of medical device for the US and European markets
- Developing risk assessment for both commercial and preclinical devices. Specifically, on crysurgical delivery devices and home-use ventilators
- Working in ISO 13485 Quality Systems
- Working with medical professionals to develop devices that meet user and patient needs
- Working with test agencies for device IEC 60601-1 3rd Ed. compliance and testing
Experience
- Worked 10+ years in medical device development through FDA approval and launch
- Developed field retrofittable LN2 control/delivery system for endoscopic and bronchoscopic cryosurgical device
- Managed IEC 60601-1: 2015 and Collateral Standards design requirements and compliance for pediatric home use ventilators
- Supported multiple FDA Submission and medical device product launch
- Designed a scalped anchored EEG electrode reducing the volume of electrical paste required
- Prototyped the miniturization of a sleep apnea breathe meter improving efficacy in sleep labs, clinical settings and home use
Software: Design Complete
Hardware: Pre-production units for design verification
MFG. Readiness: CM schedule and budget, Unit build tracking