Matt Selbach

About Matt Selbach

Proven medical device Quality leader with deep expertise in Product Risk Management and Quality Management Systems, driving the launch and stewardship of innovative and life changing medical devices. My approach blends pragmatism and grit with a commitment to innovative, sustainable solutions and process excellence. I inspire and develop high-performing teams, fostering a culture of honesty, active listening, and close collaboration—both within teams and across functions—to drive organizational transformation and deliver results. By engaging with Competent Authorities and leading through change and crisis, I leverage cross-functional collaboration to continuously learn, adapt strategies, and ensure best-in-class execution that meets the evolving needs of the business for lasting impact.

Experience

1. Quality Engineering Director, Post-market Risk

   Medtronic

   Jan 2025 — Present

Education

• Boston University

  B.S, Biomedical Engineering

• Indiana University - Kelley School of Business

  Master of Business Administration - MBA, Entrepreneurship and Corporate Innovation

Skills

• Iso 13485
• Iec 60601
• Root Cause Analysis
• Solidworks
• Risk Analysis
• Iso 14971
• Quality System
• V&V
• Rational Doors
• Validation
• Comsol
• Fmea
• Imagej
• U.s. Food and Drug Administration (Fda)
• Microsoft Office
• Design Control
• Graphpad Prism
• Agile Project Management
• Mathcad
• Corrective and Preventive Action (Capa)
• Fda
• Microsoft Excel
• Sigmaplot
• Biomedical Engineering
• Matlab
• Medical Devices
• Capa
• Failure Mode and Effects Analysis (Fmea)