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Senior Software Project Manager w2 only
- Sunnyvale, California, United States
- Sunnyvale, California, United States
Über
The
Senior Software Project Manager
will lead and coordinate the development of
cutting-edge surgical robotic platforms
, managing the
full software development lifecycle (SDLC)
and ensuring
compliance with medical device standards
.
This role involves close collaboration with
cross-functional teams
across software, controls, hardware, product management, clinical design, human factors, regulatory, and quality engineering.
Key Responsibilities
- Manage end-to-end SDLC: requirements, design, development, testing, validation, documentation, and release.
- Lead cross-functional project teams; facilitate effective communication between stakeholders.
- Develop project schedules, set milestones, allocate resources, track progress, and manage risks.
- Provide regular status updates and report critical paths and risk areas to stakeholders.
- Ensure compliance with medical device regulatory standards including
IEC 62304, ISO 13485, ISO 14971, and FDA 21 CFR Part 820
. - Implement best practices and continuous improvement in project management methodologies (Agile, Waterfall, Hybrid).
- Manage budgets, forecasts, and resources to ensure on-time and on-budget delivery.
Required Qualifications
- Bachelor's or Master's degree in
Computer Science, Engineering
, or a related technical discipline. - 8+ years
of project management experience in software development. - 2–3 years
of experience in
medical device or robotics projects
.
- Proven success managing software projects for
medical or surgical robotic devices
.
- Strong knowledge of Agile, Waterfall, and Hybrid
development methodologies.
- Familiarity with
surgical robotic platforms, control software, hardware integration,
and
surgical workflows
.
- Solid understanding of regulatory standards:
IEC 62304, ISO 14971
, with exposure to
ISO 13485
and
FDA 21 CFR Part 820
.
- Excellent
communication, leadership, and organizational
skills.
- PMP certification
.
- Experience with JIRA, MS Project, and Confluence
.
Sprachkenntnisse
- English
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