About the role
AI summarisedThe Senior Staff Software Program Manager will lead software development for a new sequencing instrument, overseeing the full New Product Introduction (NPI) lifecycle from concept to market launch. This role involves driving software schedules, managing cross-functional teams, ensuring regulatory compliance, and delivering timely software deliverables across firmware, cloud, and user interface domains. The ideal candidate has deep experience in regulated medical device development, strong program management skills, and proficiency in agile and traditional project management tools.
BiotechOnsite
Key Responsibilities
- Leading 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 by not limited to 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 (Computer Science/Engineering, Software/Electrical Engineering)
- At least 15 years of MNC working experience in a regulated industry on product development (preferably on Medical Devices)
- More than 10 years as a software project manager
- PMP certification will be a plus