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Design Control

Job Title: Design Control
Contract Type: Permanent
Location: International
Industry:
REF: 87285
Job Published: about 1 month ago

Job Description


Contact: Deidre Finnerty
Email: deidre@hero.ie
Telephone: 091 730022

Our client requires an experienced Design Control role in Germany working in a fast paced manufacturing environment.

Job Description
  • 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
For further information on this Design Control role in Germany please contact Deidre Finnerty on 091 730022 / deidre@hero.ie
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