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

• At least 5 years of experience in Medical Device (development/Sustenance/DHF Remediation)

• Sound understanding of ISO 13485, IEC 60601, and ISO 14971 Standards

2COMS