About this role
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 data-driven execution.
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 data-driven decision-making. • Maintain transparency through structured reporting mechanisms. Stakeholder Management
• Provide regular updates to senior leadership with concise, data-backed insights. • Manage expectations across stakeholders and ensure alignment on priorities and trade-offs. • Enable decision-making through clear articulation of options, risks, and impacts. Continuous Improvement
• Drive process improvements in project execution, governance, and delivery efficiency. • Leverage tools and automation (e.g., CI/CD metrics, dashboards) to enhance visibility and predictability. • Contribute to best practices for platform-based development and reus
Required Qualifications
• Bachelor’s or Master’s degree in Engineering (Computer Science, Electronics, or related field). • 8–12 years of experience in project/program management in software or embedded systems. • Proven experience in regulated industries (medical devices preferred). • Strong understanding of software development lifecycle (SDLC) and Agile/Hybrid models. • Experience managing complex, multi-site, cross-functional projects.
Preferred Qualifications
• Experience with platform-based product development (multi-product/multi-platform environments). • Familiarity with regulatory submissions (e.g., FDA 510(k), CE Mark). • Experience with requirements and lifecycle tools (e.g., JAMA, DOORS, Jira). • PMP / Agile certification is a plus.
Key Skills
• Strong leadership and stakeholder management • Excellent communication and executive reporting skills • Risk management and problem-solving • Planning, estimation, and dependency management • Ability to work in global, matrixed organizations Success Metrics
• On-time milestone delivery (P/M alignment) • Quality and compliance adherence • Risk mitigation effectiveness • Stakeholder satisfaction and alignment • Predictability and execution efficiency Behavioral Competencies
• Ownership and accountability • Structured thinking and execution discipline • Collaboration and influence without authority • Continuous improvement mindset
Additional Information Relocation Assistance Provided: No