Summary
Christopher Gauffin is a project manager and process engineer with a decade of experience launching regulated medical devices across the US, Sweden and Japan, and deep expertise in FDA 21 CFR Part 820, ISO 13485 and MDR-compliant development. He has led cross-functional teams at SHL Medical and Nobel Biocare, driving digital PLM initiatives, operational excellence, and data & analytics projects that bridge R&D and manufacturing. Trained as a mechanical engineer with a MSc in biomedicine and a Six Sigma Black Belt, he combines technical rigor with continuous improvement to reduce risk and accelerate time-to-market. Not obviously evident from titles alone, Christopher often acts as the SME who translates complex regulatory requirements into practical production processes and traceable quality systems. Based in Stockholm, he brings a pragmatic, global perspective from hands-on roles in both product development and operations.
10 years of coding experience
3 years of employment as a software developer
KTH Royal Institute of Technology
Black Belt 2012, Black Belt: Six Sigma, Black Belt 2012, Black Belt: Six Sigma at Sandholm Associates
English, Japanese, Swedish, Spanish