Hands-on software/hardware/systems engineering manager in the medical device/life science industry. Extensive experience leading the development of innovative products by geographically dispersed technical teams. Problem-solver, team-builder and mentor with a wide range of expertise:
- Leadership: Successfully created, built and led interdisciplinary development programs. Skilled at working with multiple stakeholders (clinical, engineering, business, marketing, and sales) to optimize development goals and outcomes.
- Product Innovation: Led international teams in the design and development of devices including in-vitro diagnostics, cardiac and telehealth monitoring, nervous system diagnostics, laser ablation, and others.
- Quality and Regulatory Expertise: Experienced in developing and using quality management system (QMS) and design processes that are compliant with FDA, IEC, ISO, and other standards, and in preparation of FDA 510(k) submissions.
- Creative Problem-Solving: Holder ofeight US patents in signal processing, low power wireless communications, and other medical technologies. Frequently called on to “turn-around” projects.
- Thought Leadership: Author of a widely adopted college textbook on computer communications and numerous published articles, and speaker at national meetings on medical technology topics.