Scientist I
Current- Coordinated biocompatibility testing and managed a team to facilitate US 510K and EU MDR regulatory filings for multiple class 3 medical device products
- Collaborated with Engineering and Operations teams to conduct root-cause investigations and implement process improvements reduce down-time by 20% and enhance employee safety
- Developed methods to manufacture and process biodegradable filaments and textiles for use in tendon augmentation applications
- Performed diligence on potential collaborators and suppliers to assess investment opportunities and ensure product quality
- Evaluated novel orthopedic suture prototypes and mechanism of action in pre-clinical ovine animal and cadaveric models for use in lateral ankle instability
- Led exploratory R&D projects (3) following ISO 13485 & FDA 21 CFR part 820 for development of adhesion barriers and joint replacement devices