Software Project Manager

Responsibilities

• Leading the planning and execution of complex software development and integration programs
• Partnering closely with R&D, Quality, Regulatory, IT, Cybersecurity, Clinical, Operations and other cross-functional teams to integrate acquired software technologies into the company's medical device portfolio while ensuring compliance with global regulatory standards and internal quality systems.
• Drive alignment between legacy and acquired development processes, tools, architectures, and documentation.
• Develop and maintain integrated program 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 and stakeholders
• Partner with software engineering teams to ensure development and integration activities comply with applicable standards (e.g., IEC 62304, ISO 14971, ISO 13485).
• 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.
• Drive issue resolution and decision‑making across organizational boundaries.
• Track project progress, manage budgets, and provide transparent communication and interfaces with all areas affected by the program/project including cross-functional stakeholders, business sponsors, and senior management.
• Conduct retrospectives, and lessons learned, and implement process improvement initiatives to drive future success.
• Additional duties, as assigned.

Key Competencies and Capabilities

• Ability to plan and execute software‑centric projects in the medical device industry, with preferred experience in medical device software, including new product development and sustaining software or mobile applications.
• 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.
• Working understanding of software‑enabled electro‑mechanical systems, including firmware, embedded software, and system‑level integration, sufficient to support cross‑functional execution.
• Strong verbal and written communication skills, with the ability to collaborate across Software, Systems, Quality, and Regulatory teams and drive on‑time delivery.
• Demonstrated organizational and problem‑solving skills, with the ability to manage assigned scope and operate effectively within a regulated, quality‑driven environment.

Required Qualifications

• Bachelor's degree in Engineering, Computer Science, or related technical discipline.
• 5-8 years of experience in program or 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 lifecycles and quality systems.
• Proven ability to manage complex, ambiguous programs with multiple stakeholders.
• Percentage of Travel: Up to 25%

Preferred Qualifications

• Experience supporting mergers, acquisitions, or technology integrations.
• Familiarity with FDA, EU MDR, and global regulatory expectations for software‑enabled medical devices.
• Experience with cybersecurity, cloud‑connected devices, or mobile health platforms.
• PMP, PgMP, Agile, or SAFe certification.
• Master's degree in Engineering, Management, or related field.