LocationSan Diego, CA. Hybrid.
Position SummaryIllumina'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.
ResponsibilitiesIVD 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
Listed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position. Changes to individual responsibilities may occur due to business needs.
QualificationsRequired- 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
All listed requirements are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional tasks and responsibilities.
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The estimated base salary range for the Director, Software Technical Product Management - IVD / SaMD role based in the United States of America is: $205,100 - $307,700. Should the level or location of the role change during the hiring process, the applicable base pay range may be updated accordingly. The range reflects long-term growth in the role; therefore, most candidates are hired between the minimum and middle of the range. Placement depends on experience, skills, location, and internal equity. Additionally, all employees are eligible for one of our variable cash programs (bonus or commission) and eligible roles may receive equity as part of the compensation package. We offer a wide range of benefits as innovative as our work, including access to genomics sequencing, family planning, health/dental/vision, retirement benefits, and paid time off.
