DHF Remediation Test Engineer - EU MDR
Code Work It Solutions · Pune · onsite · Posted 7d ago
Undisclosed1–4 yrsfulltimeSourced from
About a minute. You'll make an account on the way through.
About this role
Job Summary
Key Responsibilities
Required Skills Qualifications
Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.
Review design documentation, develop and execute verification and validation activities, maintain traceability, and support regulatory compliance for medical devices
Key Responsibilities
- Support DHF remediation activities for legacy and new medical devices
- Review design documentation and identify gaps against regulatory requirements
- Create, update, and execute Verification Validation (VV) test protocols
- Develop and maintain test cases and test procedures
- Execute functional, system, regression, integration, and compatibility testing
- Analyze test results and document defects
- Work with development teams to resolve identified issues
- Maintain complete traceability between requirements, risks, design outputs, and test evidence
- Review and update DHF documentation, including Software Requirements Specifications (SRS), Software Design Descriptions (SDD), VV reports, risk management documents, and the Requirements Traceability Matrix (RTM)
- Participate in design reviews and regulatory audits
- Support defect management using JIRA, ALM, or similar tools
- Ensure compliance with quality processes and applicable regulatory standards
Required Skills Qualifications
- Strong understanding of DHF remediation activities
- Hands-on experience with EU MDR remediation projects
- Experience in the medical device software development lifecycle
- Strong experience in verification and validation testing
- Experience with requirements traceability and risk-based testing
- Knowledge of EU MDR 2017/745, IEC 62304, ISO 14971, ISO 13485, and FDA 21 CFR Part 820 / QMS
- IEC 60601 knowledge is preferred
- Experience with defect tracking tools such as JIRA, ALM, or Azure DevOps
- Strong documentation and communication skills
Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.
Sourced from naukri
Skills
AlmDevopsAzure DevopsCfrRegulatory AuditsISO 13485regressiondefect trackingauditsDefect managementJira AtlassianRegulatory ComplianceMedical DevicesCommunication SkillsRisk ManagementSoftware DesigncomplianceMicrosoft Azure