Software Project Manager

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. EOE Statement Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status. #J-18808-Ljbffr Real