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Technical Lead - PDO

Job Description

Alchemy are currently partnering with a global technology firm who are looking to recruit a Technical Lead - PDO to be based onsite in Round Lake , IL.

Required experience:

  • EU MDR remediation/ DHF remediation support
  • Good understanding of medical device product lifecycle, DHF documentation, Design verification, redlining specifications, Change management process
  • Knowledge on ISO 13485/ Product design and development, FMEA, PFMEA, Risk management, CAPA Process
  • Good in documentation process, engineering documentation and specification standardization
  • Strong analytical skills with the ability to collect, organize, analyze Design related data from various specification documents
  • Ability to understand large structured and unstructured data with attention to Design parameters from various products
  • Demonstrated superior communication (written and verbal), teamwork, and organizational skills
  • Experience in PLM tools – ERP, Teamcenter, SAP and any other PLM Tools
  • Experience in Trackwise
  • Excellent skills in MS Office (Word, Excel & PowerPoint) and MS Access tool
  • Highly proficient in configuration management
  • Maintain and own internal documents
  • Write, revise and review SOP's