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Design Controls, Subject Matter Expert (SME)

Job Title: Design Controls, Subject Matter Expert (SME)
Contract Type: Permanent
Location: International
Industry:
REF: 87286
Job Published: about 1 month ago

Job Description

Contact: Anne Gough
Email: anne@hero.ie
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.

Job Description
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 / anne@hero.ie
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