ID1052
Medical Device Manufactoring
Dipl. ing. Industrial Engineering and Mngt., TU Berlin
Available for: Part-time, full-time, tasks
Contact us for full CV
Competences
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Medical Device Production Development
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Project Management
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Verification, product transfer, validation
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Product management
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Quality management
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Risk management
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MDR
Key results
2020-22:
Interim-COO: Designed / Sourced / Built / Validated 3 production lines (Class III and biocide)
2018:
COO: Led Development of a Class IIa/IIb Medical Device
2011:
Global Product Manager: Launched 7 Medical Devices (Class I) in 2 years. Responsible for a $40M portfolio of 150+ products
Software/Standards
- 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
Personal Characteristics
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.
Contact
Medicologic A/S
Arne Jacobsens Alle 15-17
DK-2300 København S
Denmark
(+45) 48 24 51 13
contact@medicologic.com
Medicologic-profile
Where to find us
Michael Funder
Owner / Director
(+45) 20 64 41 46
mf@medicologic.com
Lars Bo Andersen
CFO / Administration
(+45) 31 13 51 05
lba@medicologic.com