MedTech Technical Project Manager – Edge AI, Connectivity Platform
Codvo.ai
full-time
Posted on:
Location Type: Remote
Location: India
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Tech Stack
About the role
- Lead overall program/project execution for the Edge AI & Connectivity Platform, driving timelines, budgets, compliance, and stakeholder alignment.
- Manage Agile sprint planning, backlog grooming, dependency mapping, and change request processes.
- Coordinate workstreams involving embedded firmware, edge computing, AI/ML pipelines, cloud services, and regulatory documentation.
- Serve as the single point of accountability for internal teams and client delivery leads.
- Ensure alignment with medical device regulations and standards, including: FDA 510(k) HIPAA and GDPR IEC 62304 (software lifecycle)
- ISO 13485 (QMS) ISO 14971 (risk management).
- Track and mitigate risks, manage RAID logs, and ensure proactive escalation and resolution of delivery blockers.
- Monitor traceability from user needs to validation artifacts to ensure audit readiness and compliance documentation.
- Collaborate with domain SMEs, architects, QA leads, and business analysts to ensure functional and technical completeness.
- Conduct regular client-facing meetings, sprint demos, roadmap updates, and steering committee presentations.
- Maintain release cadence and ensure documentation for design controls, V&V, and change management.
Requirements
- 10–15 years of experience in technical project/program management.
- At least 5+ years leading delivery in regulated product development, ideally in MedTech, HealthTech, or Industrial IoT.
- Experience managing globally distributed engineering teams with Agile/Hybrid execution.
- Strong working knowledge of embedded systems, data engineering pipelines, AI/ML model lifecycle, and edge-to-cloud architectures.
- Proven ability to collaborate with regulatory teams and contribute to submission readiness (e.g., FDA 510(k), CE Marking).
- Familiarity with Design History File (DHF), traceability matrices, and regulatory design controls.
- Experience supporting quality audits and contributing to documentation required by Notified Bodies or FDA reviewers.
- Exposure to medical cybersecurity frameworks and privacy risk assessments.
Benefits
- Travel may be required for project workshops, audits, or stakeholder meetings.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
Agileembedded firmwareedge computingAI/ML pipelinescloud servicesrisk managementregulatory documentationdata engineeringtraceability matricesdesign controls
Soft Skills
stakeholder alignmentcollaborationcommunicationproblem-solvingleadershipproject managementrisk mitigationclient-facingorganizational skillspresentation skills