Technical Program Management Professional
Current- Planning development of new products from concept stage through customer delivery plus support and maintenance of existing products and services- Performing feasibility studies and defining technological and design specs with attention to detail- Forecasting, prioritizing, and managing project budgets of up to $4 million, schedules of up to 2 years, and teams of up to 20 resources- Strong interpersonal skills for bringing consensus between customers / stakeholders and resources from sales & marketing, engineering (software, electrical, and mechanical), verification & validation testing, regulatory & quality affairs, usability & human factors evaluations, purchasing & supply chain management, operations & manufacturing, and service & support- Performing analysis, planning mitigation, and managing risks of projects / products- Interfacing with external customers: physicians, nurses, medical directors, and technicians / biomeds - Creating artifacts and maintaining project files, design history files (DHF), and traceability matrices- Managing vendors for development of software, devices, components, supplies, and accessories- Flexible and persistent in face of risks and challenges for each project / product while interfacing FDA, ISO, IEC, European Council (CE mark), HC, TÜV, CSA, UL, and other regulatory agencies- Functional leadership in recruitment, team / talent development, skill set improvement, and mentoring- Detailed design and integration of precision sensors and control systems for biomedical devices with simulation of environmental and physiological parameters- Broad experience and knowledge of ECG and respiratory monitors, pulse oximeters, capnography monitors and airway gas analyzers, invasive and noninvasive blood pressure machines, defibrillators, anesthesia delivery systems, ventilators, and bispectral index (BIS) monitors
