Design Control Engineering
Medical Device R&D Expert
Available for: Part-time, tasks
Contact us for full CV
- Excellent task force leader with ability to provide clarity in complex and multidisciplinary problems.
- Solid technical knowledge in mathematical modelling, software, digital design, sensors, optical and mechanical systems.
- Concept development and testing.
- Product Verification and Validation.
- Deep understanding of regulatory requirements including design controls (ISO 13485), risk management (ISO 14971) and IEC 60601-1.
- Software/Languages: Matlab, Python, JMP, C#, Java,C/C++, assembler (e.g. BF561), VHDL.
- Led multiple task forces improving production or product quality issues incl. extending the lifetime of dielectric mirrors from 20 to 250 autoclave cycles.
- Developed and realized concept for accurate colorscanning in market leading intraoral scanner.
- Designed and developed a manufacturing method for an advanced calibration object allowing co-calibration of optical systems with an X-ray system.
- Successful liaison between R&D and RA on technical documentation for conformity assessment of EU MDDClass IIb product.
- Build ISO 13485:2016 and MDR compliant QMS in a start-up company.
He is curious in nature and thrive by digging into complex and multidisciplinary problems. He uses his broad and solid technical background to facilitate and engage in deep discussion and analysis to bring about the best solution or find the best way to attack a problem.
He is great at leading task forces and always has an eye on the timeframe and on delivering results.
With more than 8 years of experience developing medical devices, he also understands the regulatory requirements, processes and documentation needs very well.
Arne Jacobsens Alle 15-17
DK-2300 København S
(+45) 48 24 51 13
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