Contact: Deidre Finnerty
Telephone: 091 730022
Our client requires an experienced Design Control role in Germany working in a fast paced manufacturing environment.
- Design Controls, Subject Matter Expert (SME)
- The company, a leading medical device company in Baden Wurttemberg, Germany is currently looking to recruit a Design Controls Subject Matter Expert.
- 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
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