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Technical Engineering Lead

Job Description

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

Required experience:

  • Good understanding of Medical device product lifecycle, DHF remediation support, DHF documentation update, Label verification, Redlining specifications, Change management process
  • Test Method Validation qualification, Gage R&R, Fixture creation 
  • Hands on Laboratory testing experience with Physical/ Functional test 
  • Experience in Electronic Laboratory Notebook 
  • Good in documentation process, data Integrity and reviews, engineering documentation and specification standardization
  • Equipment knowledge – Pressure Systems, Instron (Force, tensile, compression) 
  • Study/ Protocol author and perform data analysis with statistical tools (Minitab) 
  • Knowledge on ISO 13485/ Product design and development, FMEA, PFMEA, Risk management, CAPA Process
  • Demonstrated superior communication (written and verbal), teamwork, and organizational skills
  • Highly proficient in configuration management
  • Maintain and own internal documents