Lead end-to-end planning and delivery of software and embedded medical device programs. Define scope, timelines, and milestones; manage cross-functional global teams; ensure compliance with IEC 62304/ISO 13485 and QMS; track risks, KPIs, and DHF documentation; drive governance forums and continuous improvement using CI/CD metrics and lifecycle tools.
Job Description SummaryResponsible 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.
- 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.).
- 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.
- 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.
- Identify, assess, and manage project risks, issues, and escalations.
- Drive timely resolution through data-driven decision-making.
- Maintain transparency through structured reporting mechanisms.
- 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.
- 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.
- 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
Additional Information- 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
- On-time milestone delivery (P/M alignment)
- Quality and compliance adherence
- Risk mitigation effectiveness
- Stakeholder satisfaction and alignment
- Predictability and execution efficiency
- Ownership and accountability
- Structured thinking and execution discipline
- Collaboration and influence without authority
- Continuous improvement mindset
Relocation Assistance Provided: No
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