Work from Office
Full Time
Experience: 4-8 years
Location: Pune / Hyderabad / Remote (as applicable)
Domain: Medical Devices – Software as a Medical Device (SaMD)
We are seeking a DHF Remediation Engineer with strong hands-on experience in Software Quality Assurance for SaMD, specifically in EU MDR technical file gap assessment and remediation. The role requires deep expertise in software DHF artifacts for desktop applications, strong regulatory judgment, and the ability to lead remediation activities independently while interfacing with cross-functional teams and customers.
Key ResponsibilitiesLead DHF gap assessment and remediation activities for SaMD desktop applications aligned to EU MDR.
Own and review Software Technical File documentation, including:
Software Development Plans
Software Architecture & Design documents
Software Risk Management (aligned with ISO 14971)
Verification & Validation (V&V) documentation
SOUP assessment and anomaly resolution
Ensure compliance with IEC 62304, with clear traceability across requirements, risks, and tests.
Perform software quality assurance reviews and provide regulatory-compliant remediation strategies.
Drive closure of MDR-related audit findings, NB comments, and internal QA observations.
Mentor junior engineers and provide technical guidance on DHF best practices.
Participate in customer discussions, reviews, and regulatory readiness assessments.
Strong hands-on experience in SW DHF remediation for SaMD.
In-depth understanding of EU MDR requirements for SaMD submissions.
Proven expertise in IEC 62304 lifecycle processes.
Experience with desktop software applications (Windows/Linux/macOS).
Strong knowledge of software risk management, traceability, and design controls.
Ability to independently drive remediation with minimal supervision.
Experience working with Notified Body queries.
Exposure to MDD to MDR transition projects.
Prior experience in service organizations supporting global medical device clients.
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