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 :

- 1015 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.