Hiring Medical Device Development Professionals
Hiring Medical Device Development Professionals
Posted on :
19-02-2025
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1 Vacancy
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Job Description
Job Description: Medical Device Development Engineer
Educational Qualification: BE in Mechanical Engineering or Biomedical Engineering
Experience: 5 years
Location: Bangalore or Pune
Notice Period: Immediate to 1 week
Job Responsibilities:
- Conduct gap assessment and create/update DHF documents including user requirements product requirements Element and Part requirements Design FMEA CTS/CTQ and Standards compliance reports
- Understand the changes needed as part of Design change requests and perform an impact assessment of the design/documentation based on the change
- Identify gaps in verification and validation and establish clear traceability 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 and process the changes through PLM
Requirements
Requirements:
- At least 5 years of experience in Medical Device (development/Sustenance/DHF Remediation)
- Sound understanding of ISO 13485 IEC 60601 and ISO 14971 Standards
Job Description: Medical Device Development Engineer Educational Qualification: BE in Mechanical Engineering or Biomedical Engineering Experience: 5+ years Location: Bangalore or Pune Notice Period: Immediate to 1 week Job Responsibilities: Conduct gap assessment and create/update DHF documents including user requirements, product requirements, Element and Part requirements, Design FMEA, CTS/CTQ, and Standards compliance reports Understand the changes needed as part of Design change requests and perform an impact assessment of the design/documentation based on the change Identify gaps in verification and validation and establish clear traceability 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 and process the changes through PLM Requirements Requirements: At least 5 years of experience in Medical Device (development/Sustenance/DHF Remediation) Sound understanding of ISO 13485, IEC 60601, and ISO 14971 Standards
Education
Graduate
Employment Type
Full Time
Key Skills
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