1 ISO 13485 Jobs in India
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Bengaluru (Bangalore), Pune · 5 - 10 years · ₹2L - ₹12L / yr · Raised funding · Posted 11 Feb 2025
Job Title : Medical Device Engineer
Location : Bangalore / Pune
Experience : 5+ Years total, with at least 3 years in Medical Device Development, Sustenance, or DHF Remediation
Notice Period : Immediate to 1 week
Interview Process : L1-selected candidates will undergo a customer interview
Mandatory Skills : Medical Device Development/Sustenance/DHF Remediation, ISO 13485, IEC 60601, ISO 14971, FDA & EU MDR compliance, DHF documentation, Design FMEA, CTS/CTQ, QMS, PLM, Verification & Validation, Impact Assessment.
Key Skills & Knowledge :
- Strong understanding of ISO 13485, IEC 60601, and ISO 14971 standards
- Experience with FDA and EU MDR regulatory requirements
Responsibilities :
- Conduct gap assessments and create/update DHF documents, including user and product requirements, design FMEA, CTS/CTQ, and standards compliance reports
- Analyze and implement design changes, assess impact, and update documentation accordingly
- Identify gaps in verification and validation, ensuring clear traceability between requirements and verification documents
- Assess compliance with applicable standards and regulations
- Define CTS/CTQ parameters and actively participate in design reviews
- Follow QMS guidelines and manage changes through PLM.
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