Staff Program Manager - Software Development

at  Thermo Fisher Scientific

POSITION SUMMARY

The Staff Program Manager will be a pivotal contributor in advancing the strategic initiatives within the software business segment of the Transplant Diagnostics division. This role involves leading programs that support our internal software tool development programs, as well as the development of Research Use Only (RUO) and In Vitro Diagnostic (IVD) software products. To be successful, this high-visibility position demands effective leadership over multiple tasks and teams, requiring a candidate with a collaborative approach, focus on deliverables, and excellent interpersonal skills. Moreover, this role requires a blend of proficiency in software development, program management best practices, and the ability to cultivate strong industry relationships.

EDUCATION AND EXPERIENCE

• Bachelor’s degree in Computer Science, Math, Science, or a related technical field. Advanced degree in technical/scientific field preferred.
• Minimum 5 years demonstrated experience leading software product development projects in an ISO 13485 regulated environment using traditional project management methodologies (e.g., phase gate processes, waterfall, etc.).
• PMP certification a plus.

KNOWLEDGE, SKILLS AND ABILITIES

• Proven ability to influence and drive accountability across a matrixed organization.
• Outstanding written and verbal communication skills: assertively and effectively articulates sophisticated concepts and ideas to broad audiences.
• Familiar with Medical Device Manufacturing and Design Controls for the development of medical devices (e.g., 21CFR820, ISO 13485).
• Experience with waterfall and scaled agile framework and/or quarterly planning processes in software development.
• Self-managing and self-motivating, capable of prioritizing tasks effectively to meet timelines and expectations.Is curious, inquisitive, innovative, and never satisfied with the status quo. Posseses a proactive, helpful, ‘can-do’ attitude.

• Lead cross-functional core teams and conduct regular project meetings (including taking and sharing minutes), supervise assigned deliverables, develop timelines, and build presentations for senior leadership at critical phase gates.
• Guide the development, verification, validation, and release of RUO and IVD software applications, aligning them with market needs, regulatory guidelines, and customer requirements.
• Identify potential risks and issues, along with developing effective mitigation strategies. Proactively address challenges to maintain compliance, product quality, and project execution.
• Continuously define and optimize software project management and development processes, methodologies, and tools to improve efficiency and effectiveness.
• Maintain clear communication lines with all team members, providing regular updates on project status and achievements, and raising barriers to execution to ensure projects are completed on time with high quality and within the applicable scope and budget.