Director, Software Technical Product Management - IVD / SaMD
Illumina, Inc.
November 13, 2026
Full-time
Remote friendly (US - California - San Diego)
United States
IT
What if the work you did every day could impact the lives of people you know? Or all of humanity?
At Illumina, we are expanding access to genomic technology to realize health equity for billions of people around the world. Our efforts enable life-changing discoveries that are transforming human health through the early detection and diagnosis of diseases and new treatment options for patients.
Working at Illumina means being part of something bigger than yourself. Every person, in every role, has the opportunity to make a difference. Surrounded by extraordinary people, inspiring leaders, and world changing projects, you will do more and become more than you ever thought possible.
Location
San Diego, CA. Hybrid.
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
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.
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
All listed requirements are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional tasks and responsibilities.
#LI-HYBRID
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.
We are a company deeply rooted in belonging, promoting an inclusive environment where employees feel valued and empowered to contribute to our mission. Built on a strong foundation, Illumina has always prioritized openness, collaboration, and seeking alternative perspectives to propel innovation in genomics. We are proud to confirm a zero-net gap in pay, regardless of gender, ethnicity, or race. We also have several Employee Resource Groups (ERG) that deliver career development experiences, increase cultural awareness, and offer opportunities to engage in social responsibility. We are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information. Illumina conducts background checks on applicants for whom a conditional offer of employment has been made. Qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable local, state, and federal laws. Background check results may potentially result in the withdrawal of a conditional offer of employment. The background check process and any decisions made as a result shall be made in accordance with all applicable local, state, and federal laws. Illumina prohibits the use of generative artificial intelligence (AI) in the application and interview process. If you require accommodation to complete the application or interview process, please contact accommodations@illumina.com. To learn more, visit: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf. The position will be posted until a final candidate is selected or the requisition has a sufficient number of qualified applicants. This role is not eligible for visa sponsorship.
At Illumina, we are expanding access to genomic technology to realize health equity for billions of people around the world. Our efforts enable life-changing discoveries that are transforming human health through the early detection and diagnosis of diseases and new treatment options for patients.
Working at Illumina means being part of something bigger than yourself. Every person, in every role, has the opportunity to make a difference. Surrounded by extraordinary people, inspiring leaders, and world changing projects, you will do more and become more than you ever thought possible.
Location
San Diego, CA. Hybrid.
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
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.
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
All listed requirements are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional tasks and responsibilities.
#LI-HYBRID
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.
We are a company deeply rooted in belonging, promoting an inclusive environment where employees feel valued and empowered to contribute to our mission. Built on a strong foundation, Illumina has always prioritized openness, collaboration, and seeking alternative perspectives to propel innovation in genomics. We are proud to confirm a zero-net gap in pay, regardless of gender, ethnicity, or race. We also have several Employee Resource Groups (ERG) that deliver career development experiences, increase cultural awareness, and offer opportunities to engage in social responsibility. We are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information. Illumina conducts background checks on applicants for whom a conditional offer of employment has been made. Qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable local, state, and federal laws. Background check results may potentially result in the withdrawal of a conditional offer of employment. The background check process and any decisions made as a result shall be made in accordance with all applicable local, state, and federal laws. Illumina prohibits the use of generative artificial intelligence (AI) in the application and interview process. If you require accommodation to complete the application or interview process, please contact accommodations@illumina.com. To learn more, visit: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf. The position will be posted until a final candidate is selected or the requisition has a sufficient number of qualified applicants. This role is not eligible for visa sponsorship.