Tailoredcare
System Engineer
Skills
20 days ago
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Important information
Contract type:
Permanent
Salary:
₹400,000 – ₹800,000 / year
Location:
Pune, Maharashtra, India
Work mode:
Onsite
Published on:
30 September 2026
What they need
Role overview
The Systems Engineer will support EU MDR 2017/745 remediation programs for Class I, II
and III medical devices. The role covers gap assessment, design control remediation,
requirements engineering, traceability management, risk management, technical
documentation updates and cross-functional collaboration. The goal is compliance with
EU MDR, ISO 13485, ISO 14971 and applicable product standards.
Required skills
System engineering in the medical device domain (mandatory)
DHF (Design History File) remediation and gap assessment
V-model development lifecycle
Requirements drafting and requirements trace matrix management
DFMEA and risk management
Working knowledge of EU MDR 2017/745, ISO 13485 and ISO 14971
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