Software Project Manager

Job Title:

Software Project Manager (Medical Device)
Hybrid

Role Responsibilities:

• Serves as the primary owner for software activities, aligning technical execution with business objectives, regulatory expectations, and product roadmaps.
• Ensures that acquired software technologies are seamlessly and responsibly integrated into the medical device portfolio—turning strategic investments into safe, effective products for patients.
• Leading the planning and execution of complex software development and integration software.
• Ability to plan and execute software projects in the medical device industry, with preferred experience in medical device software, including new product development and sustaining software.
• Develop and maintain plans covering software development, verification/validation, cybersecurity, and regulatory deliverables.
• Manage program schedules, budgets, resources, risks, and interdependencies across multiple cross functional teams.
• Provide clear, data driven program status, risks, and decision points to R&D leadership.
• Drive alignment between legacy and acquired development processes, tools, architectures, and documentation.
• Work closely with software engineering teams to ensure development and integration activities comply with applicable standards.
• Ensure proper integration of software lifecycle artifacts, including requirements, architecture, risk management, verification, validation, and cybersecurity documentation.
• Support design reviews, phase gate reviews, and regulatory submissions related to integrated software products.
• Facilitate alignment on system architectures, interfaces, data flows, and platform strategies across organizations.
• Conduct retrospectives, and lessons learned, and implement process improvement initiatives to drive future success.
• Working knowledge of the software development lifecycle (SDLC) in a regulated environment, with exposure to agile or hybrid delivery models.
• Proficiency with project management and software delivery tools (e.g., MS Project, JIRA), including development of WBS, schedules, and dependency tracking.

• Bachelor’s degree in engineering, Computer Science, or related technical discipline.
• Software Development experience 5 years minimum C#, WPF Minimum 5 yrs.. hands on development experience
• Web technology Experience 2 yrs preferred
• 10-15 years of experience in software project management within software driven medical devices or other regulated industries.
• Demonstrated experience leading cross functional software development programs.
• Strong understanding of regulated software development life cycles and quality systems.
• Proven ability to manage complex, ambiguous programs with multiple stakeholders.

• Familiarity with FDA, EU MDR, and global regulatory expectations for software enabled medical devices.
• Experience with cybersecurity, cloud-connected devices.
• PMP, PgMP, Agile, or SAFe certification.
• Master’s degree in Engineering, Management, or related field.