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 data-driven execution.
Roles and Responsibilities
In this role, you will:
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Lead end-to-end planning and execution of platform and product development programs.
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Define project scope, timelines, milestones, and deliverables aligned with business and regulatory goals.
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Track progress against defined milestones (P/M milestones) and ensure adherence to commitments.
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Identify risks, dependencies, and critical paths; proactively drive mitigation strategies.
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Coordinate across engineering, systems, verification, regulatory, quality, and product management teams.
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Drive alignment between platform and product teams, ensuring seamless flow-down of requirements and deliverables.
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Facilitate effective communication across global teams (India, Europe, US, etc.).
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Ensure compliance with regulatory standards (e.g., IEC 62304, ISO 13485) and internal QMS processes.
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Support governance forums (e.g., CRB/CSB), ensuring readiness, data accuracy, and decision tracking.
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Maintain project documentation aligned with Design History File (DHF) requirements.
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Develop and maintain integrated project plans, including resource allocation and dependency mapping.
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Drive cadence-based execution and ensure alignment with release strategies.
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Monitor and report project health, KPIs, and metrics to leadership.
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Identify, assess, and manage project risks, issues, and escalations.
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Drive timely resolution through data-driven decision-making.
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Maintain transparency through structured reporting mechanisms.
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Provide regular updates to senior leadership with concise, data-backed insights.
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Manage expectations across stakeholders and ensure alignment on priorities and trade-offs.
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Enable decision-making through clear articulation of options, risks, and impacts.
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Drive process improvements in project execution, governance, and delivery efficiency.
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Leverage tools and automation (e.g., CI/CD metrics, dashboards) to enhance visibility and predictability.
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Contribute to best practices for platform-based development and reus
Required Qualifications
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Bachelor’s or Master’s degree in Engineering (Computer Science, Electronics, or related field).
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8–12 years of experience in project/program management in software or embedded systems.
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Proven experience in regulated industries (medical devices preferred).
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Strong understanding of software development lifecycle (SDLC) and Agile/Hybrid models.
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Experience managing complex, multi-site, cross-functional projects.
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Experience with platform-based product development (multi-product/multi-platform environments).
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Familiarity with regulatory submissions (e.g., FDA 510(k), CE Mark).
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Experience with requirements and lifecycle tools (e.g., JAMA, DOORS, Jira).
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PMP / Agile certification is a plus.
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Strong leadership and stakeholder management
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Excellent communication and executive reporting skills
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Risk management and problem-solving
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Planning, estimation, and dependency management
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Ability to work in global, matrixed organizations
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On-time milestone delivery (P/M alignment)
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Quality and compliance adherence
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Risk mitigation effectiveness
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Stakeholder satisfaction and alignment
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Predictability and execution efficiency
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Ownership and accountability
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Structured thinking and execution discipline
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Collaboration and influence without authority
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Continuous improvement mindset
Relocation Assistance Provided: No
