Design Controls & DHF Platform Lead

Job Description: Design Controls & DHF Platform Lead (Individual Contributor)
Domain: MedTech R&D Hardware and Software Platforms
Role Type: Ground-up Capability Building | Technical Leadership | Individual Contributor
Position Summary
Lead the establishment and deployment of end-to-end Design Controls and Design History File (DHF) capabilities for medical device hardware, software, SaMD, connected platforms, and combination products. Own design control architecture, DHF frameworks, quality engineering integration, risk management, standards compliance, and regulatory traceability aligned to ISO 13485, CDSCO MDR, FDA 21 CFR 820/QMSR, EU MDR, IEC 62304, IEC 60601, ISO 14971, IEC 62366 and related standards.
Key Responsibilities
• Build enterprise Design Controls framework and DHF architecture from concept through commercial release.
• Define product development lifecycle, stage-gates, templates, traceability models and review processes.
• Develop requirements management, system engineering and verification/validation frameworks.
• Lead Design Reviews and ensure completeness of design inputs, outputs, verification, validation and transfer documentation.
• Establish Risk Management processes per ISO 14971 including hazard analysis, FMEA, benefit-risk evaluation and risk controls.
• Drive safety, usability, cybersecurity, software lifecycle and standards compliance.
• Ensure regulatory readiness for CDSCO, FDA, EU MDR and global submissions.
• Build DHF content strategy, design traceability matrices and audit-ready evidence.
• Partner with R&D, Clinical, Regulatory, Manufacturing and Quality teams.
• Mentor teams on design controls excellence.
Required Qualifications
• Bachelor’s or Master’s degree in Biomedical, Electrical, Electronics, Mechanical, Software, Systems Engineering or related field.
• 10+ years in Medical Device/HealthTech R&D and Quality Systems.
• Deep expertise in ISO 13485 Design Controls and DHF management.
• Experience with hardware, embedded software, digital health or connected medical devices.
• Hands-on experience with regulatory inspections and audits.
Mandatory Standards & Regulatory Expertise
ISO 13485, ISO 14971, IEC 62304, IEC 62366-1, IEC 60601 family, FDA 21 CFR 820/QMSR, EU MDR 2017/745, CDSCO Medical Device Rules, cybersecurity and applicable biocompatibility and sterilization standards.
Preferred Certifications
• ISO 13485 Lead Auditor or Internal Auditor.
• ISO 14971 Risk Management Certification.
• Certified Quality Auditor (ASQ-CQA) or equivalent.
• Regulatory Affairs Certifications (RAPS preferred).
• Design Controls, Usability Engineering, Software Lifecycle and Cybersecurity training credentials.
Core Competencies
Systems Engineering, Requirements Management, Traceability, Risk Management, Product Safety, Verification & Validation, Regulatory Compliance, Design Reviews, Audit Readiness, Technical Documentation, Cross-functional Influencing, Problem Solving.
Success Measures
Establishment of a scalable Design Controls capability; Audit-ready DHFs; Successful regulatory submissions; Traceability coverage across lifecycle artifacts; On-time design reviews; Effective risk management and standards compliance.

Work arrangement
No