NC
V&V with DHF Remediation
NR Consulting - India
- 🇮🇳 India
- On-site
- 1 day ago
- Risk Management
- FMEA
- Performance Testing
- IEC
- Windchill
- Agile
- Teamcenter
1 day ago
Location: Pune
Exp: 4-9 Yrs
Job Description: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
Strong 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 · NR Consulting - India