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Design Control Engineer
Ref No.: 18-74411
Location: Cincinnati, Ohio
Position Type:Contract
Start Date: 10/04/2018
  • Experience in working in Medical device - New product development & DHF Remediation projects
  • Experience in performing Gap assessments for MDD 93/42 compliance requirements and creating remediation plans
  • Experience in Technical file gap assessments and remediation planning and executions
  • Experience in creating Design inputs / requirements, Design outputs, Design verification & Validation
  • Good understanding of EUMDR 2017/745 regulatory requirements and assessments for medical devices
  • Good understanding of ISO13485 & ISO14971 standards, 21 CFR Part 820 & EU MedDev Regulations
  • Good understanding on product sterility, biocompatibility, labeling & packaging standards
  • Experience in Risk Management plan, Hazard Analysis, DFMEA, PFMEA, Use FMEA, Software Hazard Analysis, Risk Management Report
  • Experience in updating risk management files based on post market surveillance feedback like complaints
  • Should have experience in direct interaction and co-ordination with stakeholders, customers and vendors.
  • Proficient in Solidworks (Part design, Drawing, BOM creation, assembly drawing etc).
  • Proficient in working with PLM tools like Agile / equivalent.
  • Good written and verbal communication skill and should be capable of handling the project with minimum assistance.