V&V with DHF Remediation Professional
Proffer It Consultancy · Pune · onsite · Posted 22d ago
Undisclosed4–9 yrsfulltimeSourced from
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About this role
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.
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.
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.
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.
Sourced from naukri
Skills
AgileISO 13485Biomedical EngineeringBiomedicaldiagnosticcardiovascularglobal deliveryHazard analysisElectronics EngineeringMicrosoft Office SuiteFMEAMedical TechnologyMechanical EngineeringMedical Devicescompliance