Design engineering leader with 23 years of experience creating compelling medical devices and high technology systems.Experienced at building high performance teams that develop innovative and useful medical devices - technologically-advanced diagnostic and therapeutic tools for clinicians. A cultivator of effective group culture; culture that benefits and attracts employees, clients, partners and the organization.A creator of systems and infrastructure that enable innovation, problem solving, efficiency and effective work - engaging work that is meaningful to benefit real people by saving and improving lives. Imparts a sense of urgency and ownership across all levels of an organization while also building a culture where all are respected. Established and maintained certification to ISO:13485/9001, meeting the letter and intent of FDA, other regulatory bodies and customers through many audits. And we know IEC:60601, ISO:14971, ISO:62304, ISO:62366, plus many other standards relevant to medical device compliance. Specialties: Getting important things done quickly and effectively. Creating order from chaotic situations. Turning around design organizations. Profitability. Effective teambuilding. Culture development, medical device development, engineering product development. Multidisciplinary design team leadership. Mentoring, coaching, leading by example. A portfolio of 510(k) and PMA devices that include FDA class III or II in life-critical applications. RF electrosurgery (RF Generators), pulse oximetry, glucometry, endoscopy, mechanical ventilation, in-vitro diagnosticsRequirements management, system architecture, IP development, embedded software systems, high speed digital design, analog design, interaction design, program and project management, advanced technology development, medical device regulations, ISO and FDA-compliant design control, international and domestic manufacturing, technologist and leader recruiting, organization-building, problem solving, creating new things.