Telephone: 091 730022
Senior Design Controls Engineer job in Germany
I am currently recruiting for a Senior Design Controls Engineer to join a leading medical device company in Germany. Our client requires an experienced Design Controls, Subject Matter Expert (SME) in Baden Wurttemberg and will be working in a fast paced manufacturing environment.
The company is currently running a project to remediate the Design History File (DHF) of several products. The products are consumable devices used in cardiac surgery.
The SME will work with a multifunctional design team to provide advice and guidance on plans to remediate multiple products.
Key Knowledge areas & Experience
- Design History File Remediation
- Design of Consumable devices, preferably on products which pump blood
- 510(k) including updating existing 510(k)
- Design Transfer
- 21 CFR 820.30, ISO 13485
- Risk Management to ISO 14971
- CE Submissions
- Preparation of STED Files
- dFMEA and pFMEA
- Statistical Techniques, e.g. Sample Size justification.
- Process Validation
- German & English language skills
For further information on this Design Controls, Subject Matter Expert (SME) in Germany please contact Anne Gough on 091 730022 / firstname.lastname@example.org
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