Michael Shirey

About Michael Shirey

I am a biomedical engineer and Quality leader who thrives at the intersection of engineering, quality, and system‑level strategy. Over my career, I have consistently moved from hands‑on work into leading bigger picture initiatives that reshape how organizations approach quality. My background spans manufacturing engineering, quality engineering, and process & software validation.I am motivated by big‑picture problem solving — understanding how technical systems behave, how quality frameworks shape business performance, and how organizations can evolve in the Quality space. At Integra, I lead global initiatives in the redesign of several QMS processes.Currently, I spend personal time studying in Statistical Techniques and for the ASQ CSQE cert, which reflects a personal interest in the growing space of SaMD and SiMD.

Experience

1. Senior Manager, Validation Engineering

   Integra LifeSciences

   Dec 2024 — Present · Boston, MA, US

   Lead global transformation Process Validation and CSV/CSA programs- Deliver QMS process remediation utilizing DMAIC style team process- Build interactive workshop-based training programs for program

Education

• Boston University College of Engineering

  Master of Science (M.S.), Biomedical/Medical Engineering

  2018 — 2019

• Penn State University

  Bachelor of Science (B.S.), Engineering Science

  2010 — 2014

Skills

• Labview
• Microsoft Office
• Powerpoint
• Microsoft Excel
• Engineering
• Matlab
• Some Solidworks
• Thermocouples
• Microsoft Powerpoint
• Microsoft Word
• Some Ansys
• Autocad
• Temperature Sensors