CareDx, Inc. is a leading precision medicine solutions company focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers. CareDx offers products, testing services, and digital healthcare solutions along the pre- and post-transplant patient journey, and is the leading provider of genomics-based information for transplant patients.
**This role is on-site at the Brisbane, CA location**
We are seeking a Senior Technical Business Analyst with 5+ years of experience to serve as the primary owner of business and technical requirements across complex healthcare and lab system initiatives. This role is focused on requirements strategy, workflow definition, and cross-functional alignment — not on standalone data reporting or system administration.
This is not a Data Analyst role responsible for dashboard creation, statistical modeling, or business intelligence reporting.
This is not a Systems Analyst role focused on infrastructure configuration, system maintenance, or platform administration.
Instead, this position sits at the intersection of business stakeholders, lab operations, and engineering, ensuring that:
- Business needs are clearly defined and translated into developer-ready specifications
- End-to-end workflows are documented through structured diagrams and traceable artifacts
- Requirements are aligned with regulatory standards (HIPAA, CLIA, FDA)
- Engineering teams have complete, validated documentation prior to build
As a senior-level contributor, you will own the full lifecycle of requirements — from discovery and stakeholder alignment through documentation, traceability, and UAT support. You will partner closely with engineering and architecture teams but will not be responsible for coding, data modeling execution, or system configuration.
Your impact will come from driving clarity, reducing ambiguity, and ensuring scalable, compliant system design across lab integrations and healthcare data platforms.
Key Responsibilities
- Lead complex requirements gathering efforts across business, lab operations, and software engineering teams for regulated clinical applications and healthcare integrations.
- Translate business processes into end-to-end system workflows, data flow diagrams, and technical specifications, using tools like Lucidchart, Visio, or equivalent.
- Own and drive delivery of epics and features across multiple projects; define user stories and acceptance criteria with clear traceability.
- Partner with data engineers and architects to support development of data pipelines, dashboards, and interoperability frameworks (LIMS, EHR, HL7/FHIR).
- Coordinate and validate system integration efforts with LIMS platforms (e.g., NGL LIMS, LabVantage, LabWare) or EHR systems (preferably Epic).
- Ensure alignment with HIPAA, CLIA, and FDA regulatory standards through documentation, validation, and UAT.
- Facilitate Agile ceremonies including sprint planning, backlog grooming, and retrospectives; serve as a thought partner to Product Managers and Engineering Leads.
- Provide structured communication and insights to stakeholders across the organization, including executive updates and roadmap support.
Required Qualifications
- 5+ years of experience as a Business Analyst, with at least 3 years in healthcare, diagnostics, biotech, or clinical lab environments.
- Proven experience working with LIMS systems (e.g., Epic Beaker, LabWare, LabVantage, or NGLIMS) or EHR platforms like Epic.
- Strong grasp of healthcare data standards such as HL7, FHIR, LIS, and clinical workflows.
- Proficient in writing detailed functional specs, BRDs, and user stories; skilled in data modeling, systems design, and API documentation.
- Hands-on ability to create data flow diagrams, process flows, and UML-based artifacts for engineering handoff.
- Familiarity with tools such as Jira, Confluence, Lucidchart, Tableau, and Postman.
- Experience supporting regulated environments, including user acceptance testing (UAT), validation documentation, and audit-readiness.
- Skilled in SQL and comfortable working with structured data sets for validation and reporting.
Preferred Qualifications
- Background in lab operations, clinical diagnostics, or health IT environments.
- Experience supporting multi-system integrations, middleware, or interoperability initiatives across vendor platforms.
- Based in or able to regularly commute to the Bay Area; open to West Coast-based candidates with occasional travel availability.
What Success Looks Like
- You drive business-technical alignment and make complex workflows easy to understand through structured diagrams and clear documentation.
- You build trusted relationships across Product, Lab, and Engineering by delivering high-quality artifacts and insights.
- You can independently manage ambiguity and move forward with minimal direction while keeping stakeholders informed.
- You are energized by solving real patient problems in a regulated, mission-driven healthcare environment.
Additional Details:
Every individual at CareDx has a direct impact on our collective mission to improve the lives of organ transplant patients worldwide. We believe in taking great care of our people, so they take even greater care of our patients.
Our competitive Total Rewards package for US Employees includes:
- Competitive base salary and incentive compensation
- Health and welfare benefits, including a gym reimbursement program
- 401(k) savings plan match
- Employee Stock Purchase Plan
- Pre-tax commuter benefits
- And more!
- Please refer to our page to view detailed benefits at https://caredx.com/company/careers/
In addition, we have a Living Donor Employee Recovery Policy that allows up to 30 days of paid leave annually to a full-time employee who makes the selfless act of donating an organ or bone marrow.
With products that are making a difference in the lives of transplant patients today and a promising pipeline for the future, it’s an exciting time to be part of the CareDx team. Join us in partnering with transplant patients to transform our future together.
CareDx, Inc. is an Equal Opportunity Employer and participates in the E-Verify program.
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This is the anticipated base salary range for candidates who will work in Brisbane, California. The final salary offered to a successful candidate will be dependent on several factors that may include, but are not limited to, the type and length of experience within the job, the type and length of experience within the industry, education, etc. Base pay is one part of the Total Package that is provided to compensate and recognize employees for their work, and this role may be eligible for additional discretionary bonuses/incentives and restricted stock units. CareDx is a multi-state employer, and this salary range may not reflect positions that work in other states.
Top Skills
What We Do
CareDx: Transforming Transplant Patient Care Through Novel Surveillance Management Solutions CareDx, Inc. is dedicated to improving the lives of organ transplant patients through non-invasive diagnostics. By combining the latest advances in genomics and bioinformatics technology, with a commitment to generating high quality clinical evidence through trials and registries, CareDx is at the forefront of organ transplant surveillance and pre-transplant HLA typing solutions. NASDAQ:CDNA About AlloSure® AlloSure is the first and only non-invasive blood test that directly measures allograft injury and identifies the probability of active rejection to better manage kidney transplant patients. AlloSure is a clinical-grade, proprietary Next-Generation Sequencing (NGS) based test to detect donor-derived cell-free DNA (dd-cfDNA) in order to identify organ injury in kidney transplant recipients. AlloSure is analytically validated as a sensitive, specific, and precise measurement of dd-cfDNA. AlloSure detects active rejection (acute active ABMR, chronic active ABMR, or TCMR) with high accuracy, outperforms serum creatinine in kidney transplant recipients, and is highly sensitive in distinguishing ABMR from no ABMR. AlloSure is performed in the CareDx CLIA-certified laboratory. http://www.allosure.com/ About AlloMap® AlloMap Molecular Expression Testing is a non-invasive blood test used to aid in the identification of heart transplant recipients with stable allograft function who have a low probability of moderate/severe acute cellular rejection at the time of testing in conjunction with standard clinical assessment. AlloMap testing measures the expression levels of 20 genes from a blood sample. The combined expression of these genes is represented as an AlloMap test score. AlloMap is performed in the CareDx CLIA-certified laboratory and has been commercially available in the United States since 2005. AlloMap was cleared by the U.S. Food and Drug Administration in 2008 and was CE marked for the European Union in 2011. Use of AlloMap is also included in the International Society for Heart and Lung Transplantation (ISHLT) Practice Guidelines, published in August 2010, the worldwide standard for the care of heart transplant patients. http://www.allomap.com/
