Software Project Manager

Duration: 12 months W2 contract with high possibility of extension based on performance and depending on business needs Job Summary The Software Project Lead is responsible for planning and leading complex software development and integration projects for medical devices. This role partners with cross-functional teams to deliver software solutions that meet business goals while ensuring regulatory compliance, quality, cybersecurity, and patient safety. The position oversees software programs from planning through regulatory submission and product integration. Key Responsibilities Lead planning and execution of complex software development and integration projects. Partner with R&D, Quality, Regulatory, IT, Cybersecurity, Clinical, and Operations teams. Develop and maintain software project plans, schedules, budgets, and resource plans. Manage software development, verification, validation, cybersecurity, and regulatory deliverables. Monitor project risks, dependencies, and timelines across multiple teams. Provide program status updates and recommendations to leadership. Align legacy and acquired software development processes, tools, and documentation. Ensure compliance with software development lifecycle (SDLC) processes and regulatory standards. Oversee software lifecycle documentation, including requirements, architecture, risk management, verification, validation, and cybersecurity artifacts. Support design reviews, phase-gate reviews, and regulatory submissions. Coordinate system architecture, interfaces, data flows, and platform integration activities. Drive issue resolution and cross-functional decision-making. Track project progress and communicate updates to stakeholders and senior leadership. Conduct lessons learned and implement continuous process improvements. Perform additional duties as assigned. Required Qualifications Bachelor's degree in Engineering, Computer Science, or a related technical field. 10–15 years of software project management experience in medical devices or other regulated industries. Experience leading cross‑functional software development programs. Strong knowledge of regulated Software Development Lifecycle (SDLC) and quality systems. Proven experience managing complex software programs with multiple stakeholders. Preferred Qualifications Experience developing software for medical devices. Knowledge of FDA, EU MDR, and global medical device software regulations. Experience with cybersecurity and cloud-connected medical devices. PMP, PgMP, Agile, or SAFe certification. Master's degree in Engineering, Management, or a related field. #J-18808-Ljbffr