Medical Device Manufactoring
Dipl. ing. Industrial Engineering and Mngt., TU Berlin
Available for: Part-time, full-time, tasks
Contact us for full CV
Medical Device Production Development
Verification, product transfer, validation
Interim-COO: Designed / Sourced / Built / Validated 3 production lines (Class III and biocide)
COO: Led Development of a Class IIa/IIb Medical Device
Global Product Manager: Launched 7 Medical Devices (Class I) in 2 years. Responsible for a $40M portfolio of 150+ products
- ISO 13485:2016 – Management and Implementation
- EU Regulations: MDR 2017/745
- FDA Regulations 21 CFR part 820
- ISO 62304 – Midecal Device – Software
- ISO 62366-1 – Medeical Device Usability
- ISO 14971 – Medical Device – Risk Management
- ISO 10993 – Biological Evaluation
- Microsoft Office
- Industrial CAD
He has 20 years global experience in Product Development & Management, Supply Chain Management, Regulations, Operations, Entrepreneurship, Project Finance, and Business Consulting within multiple industries.
He is a team player with a “just do it” mentality. When in the role as leader, he empowers, motivates and supports the team to reach maximal results. He gets things done.
He holds a PhD in Engineering Design, MSc Master of Production, and Dipl.ing. in Industrial Design and Management.
He has a global mindset and is fluent in English, Norwegian, and German, as well as proficient in Spanish.
In spare time he plays musical instruments and enjoys cycling and traveling.