Title: V&V; with DHF Remediation

Location: Pune

Exp: 4-9 Yrs

:Mandatory Skills -

- DHF Remediation
- Design Controls
- Technical Documentation Review
- Requirements Traceability
- Verification & Validation Documentation
- Root Cause Analysis
- Medical Device Product Development Lifecycle

Key Responsibilities

DHF Assessment & Remediation

- Perform detailed gap assessments of legacy and active DHF documentation.
- Review and remediate:

o User Needs o Intended Use Statements o Product Requirements o Design Inputs o Design Outputs o Design Review Records o Design Verification Reports o Design Validation Reports o Design Transfer Documentation o 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:

o User Needs o Design Inputs o Design Outputs o Risk Controls o Verification Evidence o Validation Evidence

- Support design review meetings and remediation closure activities.

Risk Management – Basic understanding

- Develop and update:

o Risk Management Plans o Hazard Analysis o DFMEA o Use FMEA o Risk Assessment Reports o Benefit-Risk Documentation

- Ensure alignment with ISO 14971 requirements.

Verification & Validation Support





- Author and review:

o Verification Protocols o Verification Reports o Validation Protocols o Validation Reports o 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:

o Clinical Evaluation inputs o PMS documentation review o PMCF documentation support o Labeling and IFU remediation

- Support Notified Body observations and remediation responses.

Technical Competencies

Mandatory Skills

- DHF Remediation
- Design Controls
- Technical Documentation Review
- Requirements Traceability
- Verification & Validation Documentation
- Root Cause Analysis
- Medical Device Product Development Lifecycle

Regulatory Knowledge

Robust working knowledge of

- EU MDR 2017/745
- ISO 13485:2016
- ISO 14971
- FDA 21 CFR Part 820 / QMSR
- IEC 62366
- IEC 60601 Series
- Design Control Process Requirements

Tool Knowledge

Preferred experience with

- Windchill PLM, Agile PLM, Teamcenter, TrackWise, Microsoft Office Suite

📌 V&V with DHF Remediation (Pune)
🏢 NR Consulting
📍 Pune