V&V with DHF Remediation Professional

Proffer It Consultancy; Pune District; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

BinQle is seeking a V&V professional with DHF remediation experience in Pune to review, remediate, and update DHF and Design Control documents for medical devices, ensuring compliance with EU MDR 2017/745, ISO 13485, ISO 14971, and FDA Design Control.

You will collaborate with R&D, Regulatory Affairs, Quality, and Clinical teams to perform gap assessments, develop risk management artifacts, and support Notified Body communications.

Qualifications

• DHF remediation experience required.
• Strong knowledge of Design Controls and technical documentation review.
• Experience with requirements traceability and V&V documentation.
• Root cause analysis skills.
• Understanding of medical device development lifecycle.
• Ability to perform document gap assessments independently.

Responsibilities

• Review, remediate, and update DHF and Design Control documentation.
• Ensure compliance with EU MDR 2017/745, ISO 13485, ISO 14971, and FDA Design Control.
• Collaborate with R&D, Regulatory Affairs, Quality, and Clinical teams.
• Develop and update Risk Management Plans and related documentation.
• Author and review Verification/Validation Protocols and Reports.
• Support Technical File remediation and Annex II/III updates.
• Contribute to Clinical Evaluation, PMS/PMCF, and labeling updates.
• Respond to Notified Body observations and remediation activities.

Skills

DHF Remediation

Design Controls

Requirements Traceability

Verification & Validation

Root Cause Analysis

Medical Device Lifecycle

Independent Gap Assessments

Technical Writing

Stakeholder Management

Cross-functional Collaboration

Education

Bachelor's or Master's in Mechanical/Bio/Elec Engineering or Medical Technology

Tools

Windchill PLM

Agile PLM

Teamcenter

TrackWise

MS Office Suite

Job description

Position Name: V&V with DHF Remediation

Location: Pune

Experience: 4-9 years

About BinQle

BinQle is a global delivery and execution partner supporting enterprises across the US, India, Singapore and Australia. We specialize in structured hiring, managed teams, and long-term delivery support.

Role Summary:

Responsible for reviewing, assessing, remediating, and updating Design History Files (DHF) and Design Control documentation for medical devices. Ensures compliance with EU MDR 2017/745, ISO 13485, ISO 14971, and FDA Design Control requirements. Collaborates with R&D, Regulatory Affairs, Quality, and Clinical teams.

What Youll Do:

• Perform detailed gap assessments of legacy and active DHF documentation
• Review and remediate User Needs, Intended Use, Product Requirements, Design Inputs/Outputs, Traceability Matrices, Verification/Validation Reports, and related records
• Support remediation activities per Design Control requirements and ensure traceability
• Develop and update Risk Management Plans, Hazard Analysis, DFMEA, Use FMEA, Risk Assessment, and Benefit-Risk Documentation
• Author and review Verification/Validation Protocols and Reports support testing activities
• Support Technical File remediation and assist with Annex II/III documentation updates
• Contribute to Clinical Evaluation, PMS, PMCF, and labeling/IFU remediation
• Support responses to Notified Body observations and remediation activities

What We re Looking For (Must-Haves):

• DHF Remediation experience
• Strong understanding of Design Controls and Technical Documentation Review
• Experience with Requirements Traceability and Verification & Validation Documentation
• Root Cause Analysis skills
• Knowledge of Medical Device Product Development Lifecycle
• Ability to perform document gap assessments independently
• Strong technical writing, analytical, and stakeholder management skills
• Experience working with global, cross-functional teams

Good to Have (Optional - only if mentioned):

• Experience with Windchill PLM, Agile PLM, Teamcenter, TrackWise, Microsoft Office Suite
• Experience with Patient Monitoring Devices, Ventilators, Infusion Pumps, Catheters, Surgical Devices, Imaging Systems, Cardiovascular Devices, Diagnostic Equipment, or Class II/Class III Medical Devices
• Hands-on support of EU MDR remediation programs
• Experience supporting Class II/Class III medical devices

Qualifications:

• Bachelors or Masters Degree in Mechanical Engineering, Biomedical Engineering, Electronics Engineering, Medical Technology, or related disciplines.
• Medical device quality or regulatory certifications are preferred.