Materials and Surface Applications
MSc., PhD Engineering, KTH Stockholm
Available for: Part-time, full-time, tasks
Contact us for full CV
Materials selection, and Surface modifications, including supplier assessment, aimed for Medical Device products Class II.
Profound proficiency within regulatory requirements including design controls (ISO13485), risk management (ISO14971), biological testings (ISO10993-*) and IEC 60601-1.
Process Validation within an ISO 13485 environment comprising IQ, OQ and PQ, according to GHTF/SG3/N99-10:2004.
Injection Moulding processing including process validation.
Process validation for Class II Medical Device products.
Management of innovation projects.
Implementation of surface modification (hydrophobicity) including process validation and biosafety assessment.
Accountable for the system of injection moulding at GN Hearing.
Accountable for all materials selections at GN Hearing.
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:
- ISO10993-* (Class IIa)
- US FDA regulation 21 CFR Part 820
- IEC 60601-* regulation impacting medical device
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).
Arne Jacobsens Alle 15-17
DK-2300 København S
(+45) 48 24 51 13
Where to find us