Director, Software Technical Product Management - IVD / SaMD

Position Summary

Illumina's IVD software products are an important part of our business. As Director of Software Technical Product Management — Software as a Medical Device, you own Illumina's IVD factory: the product leadership for all IVD software investments and processes that take scientific RUO software capabilities and product IVD software devices for the benefit of our customers and their patients. You manage and lead a team of 1-3 Product Managers. You own the investment decisions and business cases for IVD software launches. You'll partner with Clinical, Regulatory, Legal, Quality, and application teams to plan, fund, execute, and deliver IVD software as a continuous release train.

Responsibilities

IVD Factory Strategy and Investment

• Own all IVD software investments and processes: capability prioritization, release cadence, capacity, and cross-portfolio prioritization
• Own business cases and performance management for regulated software — funding rationale, benefit realization, and accountability for factory outcomes
• Establish a multi-year SaMD / IVD product strategy and annual release plan with explicit sequencing and success metrics
• Represent SaMD product leadership in company forums; escalate tradeoffs between business needs and regulated-release capacity with clear recommendations

Regulated Release Operating Model

• Define and run the IVD factory operating model — intake from RUO owners, freeze criteria, V&V interfaces, SRS ownership, and release readiness gates
• Partner with Clinical, Regulatory, Legal, and Quality on design controls, submissions interfaces, labeling / intended-use boundaries, and post-market quality
• Ensure Software Requirements Specifications and design-control artifacts meet Illumina's quality-system bar for IVD software releases
• Create clarity when franchise roadmaps compete for limited IVD capacity

Cross-Franchise Partnership

• Partner with Oncology, DRAGEN, Genetic Disease, Platform, and Orchestration leaders so RUO roadmaps anticipate IVD industrialization
• Align dual-use / intended-use boundaries so RUO innovation and IVD releases stay coherent
• Engage strategic and clinical customers where intended use, IVD mode, or regulated workflow behavior is decisive

Leadership

• Lead a team of technical product managers; hire, coach, and set the bar for excellent regulated-software product management
• Set objectives, performance standards, and career paths for direct reports

Qualifications

Required

• Typically requires a Bachelor's degree in a technical or scientific field (biomedical engineering, computer science, bioinformatics, molecular biology, or related) and a minimum of 18 years of related experience
• Typically 12+ years of progressive experience in product management for regulated medical device or IVD software (SaMD, FDA QSR, ISO 13485, IVDR, or equivalent)
• 3+ years of people management experience leading other Product Managers
• Track record shipping regulated software releases on a recurring cadence — not only one-time submissions
• Demonstrated ownership of investment cases and performance outcomes for regulated software programs
• Working knowledge of design controls, intended-use / labeling boundaries, and verification/validation interfaces

Preferred

• Life sciences, molecular diagnostics, or genomics experience
• Experience industrializing regulated software delivery across multiple product lines
• Advanced degree
• Cross-functional leadership across Engineering, Clinical, Regulatory, Quality, and commercial stakeholders without formal authority
• Experience building or scaling an IVD / SaMD product operating model ("factory") inside a multi-product portfolio