Development QC Engineer, Medical Products

Location: Greenville, SC, US
Job Description:
Product development engineer, responsible for establishing, practicing and maintaining QC protocols for medically oriented electronic devices developed at AVX. This will include identifying important device parameters and reliability requirements, establishing testing protocols for these characteristics, developing baseline upper and lower control limits, and collecting data to demonstrate device compliance. The position will include documenting these procedures, control limits and data in forms acceptable to customers and regulatory bodies (FDA, ISO, etc.). This position will also require analysis and documentation of defective or otherwise out - of - compliance devices using standard testing techniques.
Reports To:
Senior Member of Technical Staff
Duties and Responsibilities:
  • Statistical process control
  • Failure analysis and standard documentation techniques (8D, etc.)
  • General engineering measurements (physical, mechanical, chemical)
  • Knowledge of medical standards and compliance requirements (FDA, ISO, etc.)
  • Reliability characterization techniques (mean time to failure, accelerated testing)
Job Requirements:
  • BS or above in relevant engineering field (mechanical, electrical, materials, biotechnology or biomedical or similar)
  • Projects or cooperative/internship experience in a manufacturing environment.
  • Team experience preferred - working in conjunction with other engineering disciplines is critical.  Experience in interactions with mechanical, electrical and materials engineers is desired.
  • Communication and documentation skills vital.  Knowledge of FDA procedures is desired.
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