Senior R&D Engineer
- Led validation of potential $1B market opportunity to expand cardiovascular business. Team backed recommendation with customer input, clinical evidence, and technology analysis.
- Led $1.5M program to evaluate the safety and efficacy of an experimental drug-device combination therapy for cardiovascular disease. Managed 8-person team that designed and built a surgical delivery device; designed and executed a 28-animal chronic study; and created the regulatory and commercialization strategy. Completed on time and $300K under budget.
- Developed protocol for using Sonosite ultrasound scanner, Reveal implantable cardiac monitor, and CareLink Programmer; instructed surgical team for above pre-clinical study.
- Developed procedure for precise surgical injection into the myocardium. $200K saved in R&D costs and regulatory timeline shortened with novel use of commercial ultrasound scanner.
- Led design verification of a guide catheter obtained from a small firm prior to design freeze. Overcame challenges of managing a multi-site team operating under differing quality systems.
- Managed direct reports, gathered physician input, negotiated contracts, managed relationships with vendors and consultants, and performed technical due diligence.
- Proactively promoted innovation—pioneered and administered web-based idea management system; hosted innovation speakers; and co-led internal innovation campaigns resulting in over 30 new business concepts, 70 invention disclosures, and 150 process improvements.
- Submitted 19 invention disclosures; at least 3 patent applications filed.