Design Quality Engineer - Medical Devices

Cyient; Pune District; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Cyient seeks an experienced engineer with 5–7 years in Mechanical/Electrical/Electronic domains, preferably in medical device or regulated industries. The role requires hands-on problem-solving, knowledge of global standards, and the ability to assess changes and ensure quality compliance across design reviews and verifications.

Experience with Windchill BOM structures and compliance areas like REACH/ROHS, AGEC, SCIP is advantageous. Strong documentation and regulatory familiarity are essential.

Qualifications

• Bachelor’s Engineering degree with 5–7 years of experience in Mechanical/Electrical/Electronic or equivalent engineering (medical device or regulated industries preferred).
• Hands-on experience in problem solving techniques and understanding of global regulations, requirements, and standards.
• Knowledge of 21 CFR 820, ISO13485, ISO14971, MEDDEV, EU MDR and related standards; capable of independent technical assessment and documentation.

Responsibilities

• Performs independent technical assessment on design changes and product quality.
• Independently produces and completes Quality Engineering Documents.
• Ensures compliance during Design review, design verification & validation, and design transfer.

Skills

Problem solving

Statistical methods

Safety risk management

FMEA

Fault tree analysis

Regulatory knowledge

Education

Bachelor's in Engineering

Tools

Windchill

BOMCheck

Job description

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