About the role
AI summarisedIllumina is seeking a Senior Staff Software Program Manager to lead the software program for a new sequencing instrument. This role drives software development activities across the New Product Introduction (NPI) lifecycle, from concept and architecture through verification, validation, launch, and transition to on-market support. The ideal candidate has strong experience in SDLC, PDP, instrumentation, and regulated product development.
BiotechOnsite
Key Responsibilities
- Lead Instrument Software Workstreams throughout the NPI lifecycle, developing executable project plans, defining scope & goals, establishing WBS, and driving task ownership across engineering teams.
- Develop and manage detailed software schedules, resource plans, dependencies, and critical path analyses to ensure program milestones are achieved.
- Drive system-level integration planning for firmware, control software, data pipelines, cloud services, and user interfaces.
- Form and lead cross-functional software extended teams including technical product management, system engineering, embedded systems, cloud, and test engineering.
- Identify program risks early and implement mitigation strategies; develop and track software KPIs and health indicators.
- Partner closely with Systems, Hardware, and Advanced Science teams to ensure alignment between workflows and instrument software design.
- Deliver regular updates to senior leadership on progress, risks, and cross-functional alignment throughout the NPI phase.
- Work with software development, DevOps, software quality and support teams to deliver and ensure timely all software deliverables.
- Champion continuous improvement initiatives in software processes, tooling, and execution discipline across the NPI portfolio.
Requirements
- Proven experience in product development lifecycle and NPI program management.
- Experience managing software development projects including SW releases, environment management, and embedded FW/SW development.
- Strong working knowledge of SCRUM, SAFe, Kanban, waterfall, or hybrid models.
- Advanced proficiency with Smartsheet, Office Timeline, Jira, and Confluence.
- Experience in regulated industry with understanding of design controls (21 CFR 820.30, ISO 13485:2016, ISO 14971:2019, IEC 62304:2006).
- Familiarity with NGS workflows, data analysis, and sequencing instrumentation.
- Bachelor’s or Master’s Degree in Computer Science/Engineering, Software/Electrical Engineering.
- At least 15 years of MNC working experience in a regulated industry on product development (preferably Medical Devices).
- More than 10 years as a software project manager.