## About the Role
Prenosis Inc. is an artificial intelligence company pioneering precision medicine in acute care. Its Immunix™ precision medicine platform supports the development of precision products and enables real-time delivery of optimal therapy. Prenosis has created and validated the first FDA-authorized AI biomarker for sepsis, the Sepsis ImmunoScore®.
Prenosis is headquartered in Chicago, Illinois and generally operates on Central Time.
We are seeking a Principal Business Analyst to own the software requirements process end-to-end, from initial elicitation through documentation, validation, approval, sign-off, traceability, and change control.
This is a hands-on process-ownership role connecting business stakeholders, product management, engineering, and QA. You will define how requirements are gathered, documented, reviewed, approved, versioned, and traced across the organization while ensuring requirements remain accurate as products evolve.
## Key Responsibilities
### Requirements Process Design
Define and continuously improve the end-to-end requirements lifecycle, including elicitation, analysis, specification, validation, approval, baselining, and change management.
Develop and maintain requirements processes within the Quality Management System (QMS).
Establish consistent requirements practices across teams.
### Requirements Elicitation & Stakeholder Alignment
Conduct structured interviews, workshops, and working sessions with business stakeholders, customers, and subject matter experts.
Identify and document functional and non-functional requirements.
Translate ambiguous stakeholder input into clear, testable, and actionable requirements.
Serve as a key connection point between business stakeholders, product management, engineering, and QA.
### Requirements Documentation
Establish templates, standards, and quality expectations for requirements artifacts.
Maintain consistency across PRDs, use cases, user stories, acceptance criteria, and SRS documents.
Personally author requirements artifacts for key initiatives, including:
User stories with acceptance criteria
Functional Requirements Specifications (FRS)
Configuration specifications
Use case documents
Interface requirements
Data requirements
Ensure requirements are documented clearly enough for engineering and QA teams to work from without unnecessary follow-up clarification.
### Requirements Traceability
Build and maintain a Requirements Traceability Matrix (RTM).
Link business needs → requirements → design → test cases → release.
Ensure requirements can be traced both forward and backward throughout the product lifecycle.
### Review, Approval & Governance
Lead requirements review boards and walkthroughs.
Coordinate formal sign-off from business and technical stakeholders.
Establish and maintain requirements governance practices.
### Change Control
Own the requirements change request process after baseline approval.
Perform impact analysis for proposed changes.
Manage approval routing, versioning, and communication of changes to affected teams.
### Quality & Ambiguity Reduction
Identify requirements gaps, conflicts, and ambiguities before they reach engineering.
Ensure requirements are testable, unambiguous, and appropriately prioritized.
Work with cross-functional teams to maintain requirements quality throughout the development lifecycle.
### Compliance & Audit Readiness
Ensure requirements documentation meets applicable audit and compliance standards for regulated software environments.
Relevant standards and frameworks may include:
21 CFR 820
IEC 62304
SOC 2
HIPAA
ISO 27001
## Required Qualifications
7+ years of experience in business analysis, product management, or requirements engineering.
At least 2 years of experience owning a requirements process, rather than simply executing within an existing process.
Demonstrated experience with structured requirements elicitation techniques, including:
Interviews
Workshops
Use cases
Prototyping
Strong written communication skills with the ability to convert ambiguous stakeholder input into clear, testable requirements.
Experience with requirements management or Application Lifecycle Management (ALM) tools such as:
Jira / Confluence
Azure DevOps
Jama Connect
ReqView
IBM DOORS
Similar platforms
Familiarity with both traditional SRS-style requirements and Agile epics, user stories, and acceptance criteria.
Ability to determine when traditional or Agile requirements formats should be used.
Experience building or maintaining a Requirements Traceability Matrix (RTM).
Hands-on experience personally writing:
User stories
Functional Requirements Specifications
Configuration specifications
Prior hands-on software development experience, such as experience as a:
Software Developer
Technical QA Engineer
Solutions Engineer
Ability to read code and technical designs, ask credible technical questions, and evaluate feasibility and complexity when developing requirements.
## Preferred Qualifications
CBAP, PMI-PBA, or similar business analysis certification.
Experience in regulated healthcare software where formal requirements traceability is required for audits.
Experience with applicable standards or frameworks such as 21 CFR 820, IEC 62304, SOC 2, or HIPAA.
Exposure to API-first or platform products, including requirements involving technical contracts and interfaces.
## Core Skills
Business Analysis
Requirements Engineering
Requirements Management
Requirements Elicitation
Requirements Documentation
Requirements Traceability
Requirements Traceability Matrix (RTM)
Functional Requirements
Non-Functional Requirements
User Stories
Acceptance Criteria
SRS Documentation
Functional Requirements Specifications (FRS)
Change Control
Stakeholder Management
Agile Requirements
Quality Management Systems (QMS)
Software Development
Technical QA
Healthcare Software
Regulated Software
API Requirements
Interface Requirements
## Work Arrangement & Travel
This is a remote position.
Prenosis generally operates on Central Time.
Expected travel is approximately 2–3 times per year.
## Compensation
$120,000–$150,000 per year
## Benefits
Comprehensive medical coverage
Dental coverage
Vision coverage
401(k) with company match The source listing provided ends here, so additional benefits have not been added.
## About Prenosis
Prenosis is focused on applying artificial intelligence and precision medicine to acute care. The company values:
Put patients first
Disrupt with evidence
Excel with integrity
Go far together
Prenosis values diverse talent, continuous learning, belonging, and a shared sense of purpose.
## Equal Opportunity Employer
Prenosis is an Equal Opportunity Employer.
## Work Authorization
Candidates must be eligible to work in the United States without sponsorship.
## Apply Now
If you have 7+ years of business analysis, product management, or requirements engineering experience, hands-on software development experience, and expertise in requirements management, stakeholder alignment, traceability, Agile and traditional requirements documentation, and regulated software, apply now for the Remote Principal Business Analyst position at Prenosis.