Senior Technical Project Manager - Medical Device Software

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