Job Description Summary
Responsible for leading end-to-end execution of software platform and product development programs within a regulated medical device environment. Drives planning, milestone delivery, cross-functional alignment, and risk management across global teams. Ensures compliance with quality and regulatory standards while enabling predictable, high-quality delivery through strong governance, stakeholder engagement, and >
Job Description
Roles and Responsibilities
In this role, you will:
Program & Project Execution
- Lead end-to-end planning and execution of platform and product development programs.
- Define project scope, timelines, milestones, and deliverables aligned with business and regulatory goals.
- Track progress against defined milestones (P/M milestones) and ensure adherence to commitments.
- Identify risks, dependencies, and critical paths; proactively drive mitigation strategies.
Cross-functional Collaboration
- Coordinate across engineering, systems, verification, regulatory, quality, and product management teams.
- Drive alignment between platform and product teams, ensuring seamless flow-down of requirements and deliverables.
- Facilitate effective communication across global teams (India, Europe, US, etc.).
Governance & Compliance
- Ensure compliance with regulatory standards (e.g., IEC 62304, ISO 13485) and internal QMS processes.
- Support governance forums (e.g., CRB/CSB), ensuring readiness, data accuracy, and decision tracking.
- Maintain project documentation aligned with Design History File (DHF) requirements.
Planning & Delivery Management
- Develop and maintain integrated project plans, including resource allocation and dependency mapping.
- Drive cadence-based execution and ensure alignment with release strategies.
- Monitor and report project health, KPIs, and metrics to leadership.
Risk & Issue Management
- Identify, assess, and manage project risks, issues, and escalations.
- Drive timely resolution through >
Additional Information
Relocation Assistance Provided: No
