Verification And Validation Engineer

Glauben Technologies; Pune District; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Glauben Technologies invites an experienced DHF Remediation Engineer to strengthen compliance with EU MDR 2017/745 and ISO 13485. You will review and update DHF, risk management files, and validation documents to ensure design controls are robust and traceable across the product lifecycle.

You will collaborate with R&D, Regulatory Affairs, Quality, and Clinical teams to remediate and finalize documentation for Class II/III medical devices, reporting to the Design Control lead.

Qualifications

• Experience with DHF remediation and design controls.
• Strong technical writing and documentation skills.
• Experience with EU MDR remediation programs and gap assessments.
• Cross-functional collaboration with R&D, Regulatory, QA and Clinical teams.
• Knowledge of ISO 13485, ISO 14971 and FDA design control requirements.

Responsibilities

• Perform detailed gap assessments of legacy DHF documentation.
• Review and remediate User Needs, Intended Use, Product Requirements, Design Inputs/Outputs, and test docs.
• Ensure completeness and consistency of design control records and traceability matrices.
• Support risk management activities per ISO 14971.
• Assist with EU MDR Annex II/III documentation updates.
• Collaborate with cross-functional teams to close remediation actions.

Skills

DHF Remediation

Design Controls

Technical Documentation Review

Requirements Traceability

Verification & Validation Doc

Root Cause Analysis

Medical Device PDDLC

Tools

Windchill PLM

Agile PLM

Teamcenter

TrackWise

Microsoft Office Suite

Job description

Role 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. 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 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:

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

• 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

Preferred Medical Device Experience

Experience with one or more of the following product categories:

• Patient Monitoring Devices
• Ventilators
• Infusion Pumps
• Catheters
• Surgical Devices
• Imaging Systems
• Cardiovascular Devices
• Diagnostic Equipment
• Class II and Class III Medical Devices

Soft Skills

• Excellent technical writing skills
• Strong analytical and problem-solving abilities
• Ability to perform document gap assessments independently
• Effective stakeholder management
• Strong verbal and written communication skills
• Ability to work with global cross-functional teams and regulatory stakeholders.

Ideal Candidate Profile

• 4–12 years of experience in medical device product development, quality engineering, design assurance, or DHF remediation.
• Hands-on experience supporting EU MDR remediation programs.
• Proven expertise in traceability reconstruction, risk file updates, and remediation of Design Control documentation.
• Experience supporting Class II/Class III medical devices is strongly preferred.