ID1039
Materials and Surface Applications
MSc., PhD Engineering, KTH Stockholm
Available for: Part-time, full-time, tasks
Contact us for full CV
Competences
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Materials selection, and Surface modifications, including supplier assessment, aimed for Medical Device products Class II.
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Profound proficiency within regulatory requirements including design controls (ISO13485), risk management (ISO14971), biological testings (ISO10993-*) and IEC 60601-1.
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Process Validation within an ISO 13485 environment comprising IQ, OQ and PQ, according to GHTF/SG3/N99-10:2004.
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Injection Moulding processing including process validation.
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Process validation for Class II Medical Device products.
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Management of innovation projects.
Key results
2019-2022
Implementation of surface modification (hydrophobicity) including process validation and biosafety assessment.
2009-2018
Accountable for the system of injection moulding at GN Hearing.
2007-2022
Accountable for all materials selections at GN Hearing.
1999-2007
Founder of start-up company CytaCoat AB (www.cytacoat.com).
Software and Standards
- Microsoft Windows
- Microsoft Office 365
- Microsoft Project
- JMP Software
Extensive knowledge in:
- ISO13485
- ISO14971
- ISO10993-* (Class IIa)
- US FDA regulation 21 CFR Part 820
- IEC 60601-* regulation impacting medical device
Personal Characteristics
Is a devoted principal for actions and needs within products and applications, while considering the soft needs for customers.
Has almost 30 years of industrial experience in different areas:
medical device, surface chemistry, telecommunications, automotive and electrical distribution, all with international contacts.
Instrumental in the start-up of a medical device company (CytaCoat AB) in Stockholm, Sweden, in the early 2000.
Is furthermore expert (‘udvalgsmedlem’) at Dansk Standard (S-258).
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