MedTech Technical Project Manager – Edge AI & Connectivity Platform (India)

Overview

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 highimpact 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 submissionreadiness (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.