Bachelor’s Engineering degree with related 5-7 years of experience in -Mechanical/ Electrical/ Electronic or Equivalent Engineering (medical device or
regulated industries preferably)
Hands on experience in problem solving technique
Working knowledge of appropriate global regulations, requirements, and standards.
Understand Statistical Methods , Safety Risk Management (i.e ISO 14971) and Failure Modes and Effects Analysis (FMEA) / Fault Tree
Analysis
Applied knowledge of appropriate global medical device or consumer product regulations, requirements, and standards (21 CFR Parts
820, ISO13485, ISO14971, MEDDEV, EU MDR, etc.)
Performs independent technical assessment on design changes &product; quality
Independently produces and completes Quality Engineering Documents
Ensure the compliance requirements are met during Design review , design verification & Design validation , Design transfer

BOMCheck and solid expertise in Windchill, product BOM structures, and compliance areas like REACH/ROHS, AGEC, and SCIP.

📌 Design Quality Engineer - Medical Devices (Pune)
🏢 Cyient
📍 Pune