PUNE · FULLTIME
System Engineer
Tailoredcare
Pune · onsite · Posted 21d ago
Sourced from
₹4.0L - ₹8.0L PA5–14 yrsfulltimePune
About a minute. You'll make an account on the way through.
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- Read this posting0.2s
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Section · 01
About this role
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
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
Sourced from naukri
Section · 02
Skills
dhfEU MDRverification and validationDFMEAISORTMgapMedical EquipmentMedical Devices
Section · Company
About Tailoredcare
Tailoredcare
₹4L – ₹8L PA
This role
About
Codework.ai delivers custom software solutions that drive business transformation through agile development and digital innovation. The expert team specializes in IT strategy consulting, cloud solutions, and end-to-end software development. Solutions are designed to meet unique business needs and keep clients ahead in a rapidly evolving digital world.
The company focuses on precision, quality, and delivering results that exceed expectations. Codework.ai also offers tech recruitment to help businesses scale with top-tier talent. An experienced and proactive Business Development Manager is sought to help expand market presence by generating new projects and building strong client relationships.
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