Program Manager, Software

 Program Manager – Software

Job Summary:

The Program Manager - Software owns complex, technically challenging software programs (SaMD and SiMD), for new products and improvements to existing products, from initiation through maintenance. This role bridges technical engineering with business strategy to maximize product performance and patient safety. They lead cross-functional teams ensuring effective completion of the program. They act as the primary liaison between project teams and senior leadership providing transparent reporting on budgets, timelines, and milestones. At this level, they will bring wide-ranging experience and use professional concepts paired with company objectives to resolve complex issues in creative and effective ways. They build robust internal networks and lead in the development and training for best practices.  

Essential Duties and Responsibilities:

The incumbent may be asked to perform other function-related activities in addition to the below-mentioned responsibilities as reasonably required by business needs. 

• Program Leadership: Lead cross-functional core teams (R&D, Quality, Operations, Marketing, etc.) through the execution of the software development lifecycle (SDLC) for medical device products. Build and manage the integrated schedule and balance resourcing against it providing updates through project scorecards. Manage initial scope definition and prevent scope creep. Author project charters where required. Hold owners accountable for functional QMS and business deliverables. Lead preparation and execution of stage-gate reviews. Resolve conflicts. Identify and manage interdependencies with other projects.
• Stakeholder Communication: Serve as the primary liaison between project teams and leadership, providing transparent reporting. Act as point of escalation if needed. 
• Risk and Issue Management: Proactively identify, assess, and mitigate program-level risks and issues, developing contingency plans and initiating corrective actions when needed. Manage lessons learned.
• Compliance: Ensure all software development processes adhere to international standards, including IEC 62304 (Software Lifecycle), ISO 13485 (Quality Management), and FDA 21 CFR Part 820. Additionally, ensure compliance with Hologic business SOPs.
• Continuous Improvement and Change Management: Drive process improvements and implement best practices to enhance PMO operational efficiency. Participate in and lead capability builds. Utilize professional development to stay current in industry best practice. Build on our culture of Quality First and continuous improvement.

Qualifications: 

Education

• Preferred Minimum Non-Technical Degree: College Degree
• Preferred Minimum Technical/Advanced Degree: Master’s Degree

Experience         

• Preferred Minimum Non-Technical Degree: 5+ years in product-based Project/Program Management (preferably in regulated industry)
  • Preferred Minimum Technical/Advanced Degree: 5+ years in product-based Project/Program Management (preferably in regulated industry)
  • Experience in both waterfall and Agile methodologies – prior project execution under waterfall methodology with phase-gate design control is required.
  • Experience with SaMD and/or SiMD highly preferred.
  • Experience leading large, cross functional projects with global reach preferred.
  • Experience simultaneously leading project teams that may be in different stages of the SDLC preferred.
  • Experience with ISO and FDA regulations and quality systems and regulations highly beneficial.
  • Experience with medical device design and development cycles highly beneficial.
  • Prior experience in software development beneficial. 

Skills

• Soft Skills: Excellent written and verbal communication is integral to this role. Must be able to assess and adapt communication style to seamlessly suit different audiences. Can consistently influence without authority at both lower and higher levels of the organization. Proven history of creating and leading global, high-performing teams with the ability to facilitate group discussion and manage through conflict. Well-organized self-starter with a strong proactive work ethic. Change management training/certification is beneficial. 
• Technical and Business Expertise: Excellent problem-solving skills. Combines strong technical aptitude with analytical, business management and strategic thinking skills. Can create precise, accurate technical documentation and presentations for both technical and non-technical audiences. Proven success in risk management, design controls, and software project management. 
• Tools and Governance: Proficiency in: MS Office, Jira, and Confluence; PPM tools such as Smartsheet; dashboard generation and maintenance (PowerBI experience is beneficial). Strong knowledge of Design Controls (21 CFR 820.30), ISO 14971 (Risk Management), ISO-13485 (Medical Devices), and IEC 62304 (Software as a Medical Device) is beneficial.
• Certifications: PMP is highly preferred. Certified Scrum Professional (CSP) and Certified Scrum Master (CSM) are beneficial.