V&V with DHF Remediation (Contract)

Saaki Argus And Averil Consulting; Pune District; On-site; INR 700,000 - 1,200,000; Full time

Job summary

Saaki Argus And Averil Consulting seeks a DHF Remediation Engineer to review and update Design History Files and Design Control documentation ensuring compliance with EU MDR 2017/745, ISO 13485, ISO 14971, and FDA Design Controls. The role emphasizes risk management, traceability, and cross-functional teamwork with R&D, Regulatory, Quality, and Clinical groups.

The candidate will drive documentation accuracy, maintain lifecycle records, and support regulatory submissions as part of a medical

Qualifications

• Experience with DHF remediation and design controls.
• Familiarity with ISO 13485, EU MDR 2017/745, and FDA Design Controls.
• Strong documentation, risk management, and cross-functional collaboration.

Responsibilities

• Review, remediate, and update DHF and Design Control documentation for compliance with EU MDR, ISO 13485, ISO 14971, and FDA Design Controls.
• Lead traceability, verification/validation documentation, and root cause analysis activities as part of product development.
• Collaborate with R&D, Regulatory Affairs, Quality, and Clinical teams to ensure lifecycle readiness.

Skills

DHF remediation

Design controls

Technical documentation review

Requirements traceability

Verification & validation docs

Root cause analysis

Regulatory lifecycle knowledge

Job description

The DHF Remediation Engineer will be responsible for reviewing, assessing, remediating, and updating Design History Files (DHF) and Design Control documentation for medical devices to ensure compliance with EU MDR 2017/745, ISO 13485, ISO 14971, and FDA Design Control requirements. The role requires strong expertise in design controls, risk management, traceability, verification and validation documentation, technical file remediation, and cross-functional collaboration with R&D, Regulatory Affairs, Quality, and Clinical teams.Mandatory Skills -DHF RemediationDesign ControlsTechnical Documentation ReviewRequirements TraceabilityVerification & Validation DocumentationRoot Cause AnalysisMedical Device Product Development Lifecycle