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Medical Device Engineer
1 month ago
Job Title: Medical Device Engineer
Location: Bangalore / Pune (Hybrid)
Job Description:
Educational Qualification:
- BE in Mechanical engineering/ Biomedical Engineering
- Experience (at least 3 years) in Medical Device (development/Sustenance/DHF Remediation)
- Sound understanding of ISO 13485, IEC 60601, ISO 14971 Standards
Hands on Experience in
- Gap assessment and creation /updates of DHF documents include user requirements, product requirements, Element and Part requirements, Design FMEA, CTS/CTQ, Standards compliance reports etc
- Understanding of the change needed as part of Design change requests., Impact assessment of the design/documentation based on the change.
- Identify gaps in verification and Validation and establish clear trace between requirements and verification documents.
- Identify gaps for applicable Standards/regulations based on regulatory requirements. (FDA and EUMDR)
- Identify CTS/CTQ, Participate and Drive design reviews
- Follow the QMS,Process the changes through PLM
