Med tech - V&V with DHF Remediation Professional

ITConnectUS Inc.; Pune District; On-site; INR 700,000 - 1,000,000; Full time

Job summary

ITConnectUS Inc. in Pune, India seeks a DHF Remediation Engineer to review, remediate, and update Design History Files and design control documentation to ensure compliance with EU MDR, ISO 13485, ISO 14971, and FDA Design Control requirements.

You will conduct gap assessments, ensure traceability across User Needs, inputs, outputs, risk controls, verification, and validation evidence, and support clinical and PMS activities as part of the medical device product development lifecycle.

Qualifications

• Experience in DHF remediation and design control documentation.
• Familiarity with EU MDR 2017/745, ISO 13485, ISO 14971, and FDA design control requirements.
• Ability to establish traceability across User Needs, inputs, outputs, risk controls and verification/validation evidence.

Responsibilities

• Perform gap assessments of legacy and active DHF documentation.
• Review and remediate DHF docs including U Needs, Intended Use, Product Requirements, Design Inputs/Outputs, and traceability matrices.
• Ensure completeness and consistency of design control records across the product lifecycle.
• Support remediation activities and participate in design review meetings and closure.
• Develop and update Risk Management Plans, Hazard Analysis, DFMEA/Use FMEA, and related analyses per ISO 14971.

Skills

DHF Remediation

Design Controls

Technical Documentation Review

Requirements Traceability

Verification

Validation Documentation

Root Cause Analysis

Medical Device PDLC

Regulatory Knowledge

Job description

Job Summary

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.

Responsibilities

• Perform detailed gap assessments of legacy and active DHF documentation.
• Review and remediate DHF documentation, including User Needs, Intended Use Statements, Product Requirements, Design Inputs, Design Outputs, Design Review Records, Design Verification Reports, Design Validation Reports, Design Transfer Documentation, and Traceability Matrices.
• Ensure completeness and consistency of design control records across the product lifecycle.
• Design control activities; support remediation activities in accordance with design control requirements.
• Ensure traceability between: User Needs, Design Inputs, Design Outputs, Risk Controls, Verification Evidence, and Validation Evidence; support design review meetings and remediation closure activities.
• Risk Management - basic understanding; develop and update Risk Management Plans, Hazard Analysis, DFMEA, Use FMEA, Risk Assessment Reports, Benefit-Risk Documentation; ensure alignment with ISO 14971 requirements.
• Verification and Validation Support; author and review Verification Protocols, Verification Reports, Validation Protocols, Validation Reports, Test Method Validation Documents; review evidence supporting product safety, performance, and compliance.
• Support reliability, functional, environmental, and performance testing activities.
• EU MDR Technical Documentation Support; support Technical File remediation activities.
• Contribute to Annex II and Annex III documentation updates.
• Assist with Clinical Evaluation inputs, PMS documentation review, PMCF documentation support, labeling and IFU remediation, and Notified Body observations and remediation responses.

Technical Competencies

• DHF Remediation
• Design Controls
• Technical Documentation Review
• Requirements Traceability
• Verification
• Validation Documentation
• Root Cause Analysis
• Medical Device Product Development Lifecycle
• Regulatory Knowledge

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.