Job Title: MedTech Technical Project Manager – Edge AI & Connectivity Platform
Location: Remote (Global Coordination Across US and India Time Zones)
Travel may be required for project workshops, audits, or stakeholder meetings.
Role Overview:
We are hiring a Technical Project Manager (TPM) to lead the end-to-end execution of a next-generation Edge AI & Connectivity Platform in the MedTech domain. This high-impact role requires strong technical delivery expertise, program governance skills, and a deep understanding of regulated environments, such as medical devices and digital health.
The TPM will coordinate cross-functional global teams across embedded systems, AI/ML, cloud architecture, compliance, and quality engineering to ensure timely, compliant, and value-driven outcomes.
Key Responsibilities:
- 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.
Mandatory Qualifications & Experience:
- 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).
Preferred Experience in Regulated Projects:
- 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.
Technical Acumen Requirements:
- Comfortable navigating architecture decisions related to:
- Edge devices (e.g., ARM Cortex, NVIDIA Jetson)
- Communication protocols (MQTT, BLE, LoRa)
- Model deployment frameworks (TensorRT, TFLite)
- Cloud services (AWS/GCP/Azure for device management and analytics)
- Ability to translate complex technical interdependencies into delivery plans and resource allocation.
Delivery & Communication Competencies:
- Strong experience with project management tools (JIRA, Confluence, MS Project, Miro).
- Excellent stakeholder engagement skills across engineering, clinical, regulatory, and executive layers.
- Exceptional documentation and reporting skills for compliance, sprint artifacts, and executive dashboards.
- Ability to foster a high-trust, high-velocity delivery culture in hybrid global teams.
Certifications & Framework Experience:
- PMP or PRINCE2 (preferred)
- SAFe Agilist or Certified ScrumMaster
- Exposure to ISO 13485, ISO 14971, or HIPAA training/certifications is a strong plus.
Why This Role is Strategic:
You will play a mission-critical role in delivering a platform that shapes the future of connected healthcare combining real-time analytics, AI at the edge, and medical-grade reliability. This is a unique opportunity to work across technology, domain, and compliance layers on a global stage with a top-tier engineering and delivery team.