Chris Kovatch

About Chris Kovatch

Diagnostics professional with 10+ years experience developing, supporting and marketing IVD medical devices. Experience and skills include:Development:• Launched 4 partner led and internal IVD products (hardware and software) into the blood screening industry. These include a fully automated NAT testing platform (TIGRIS), and a sample pooling instrument with associated custom control software. • Built and subsequently managed an effective team of 5 systems engineers working across multiple hardware and software IVD development projects. • Managed department and project budgets of >$1M.• Key member of the Novartis Diagnostics R&D Leadership Team.• Key collaborator with oversight responsibilities of partner company medical diagnostics development activities (partner management). This included being the R&D member of the joint company board responsible for strategy development and resolution of escalated functional issues.• Led concept stage automation technology evaluation team for Novartis’ next generation automated NAT testing platform.• Led multiple process improvement initiatives, including the development of Novartis Diagnostic’s Requirement Management process.• Wrote and managed Product requirements documents for several hardware and software diagnostics applications.• Led the Novartis TIGRIS instrument reliability improvement initiative, resulting in a 3x improvement over 2 years.Commercial:• Wrote and managed Customer requirements documents for several hardware and software diagnostics applications.• Technical leader in the creation of a successful high throughput blood screening instrument service and support organization. • Led several international focus groups designed to gather VOC on diagnostics instrumentation and associated software.• Performed 4 successful on-site customer workflow studies designed to increase instrument reliability and lab efficiency.

Experience

1. Technical Product Manager

   罗氏公司

   Jan 2019 — Present · Tucson, AZ, US

Education

• Ohio University

  BS, Electrical Engineering

  1997 — 2002

Skills

• Minitab
• Medical Diagnostics
• Automation
• Fda
• Change Control
• Commercialization
• Customer Service
• Reliability
• Iso 13485
• Root Cause Analysis
• Requirements Management
• Quality System
• V&V
• Cross-Functional Team Leadership
• Iso 14971
• Process Simulation
• Gmp
• Change Management
• Design of Experiments
• Quality Assurance
• Biotechnology
• Human Factors
• Presentations
• Engineering Management
• Risk Management
• Medical Devices
• Capa
• Product Development
• R&D
• Mediation
• Design Control
• Validation
• Microsoft Office
• Partner Management
• Systems Engineering