Senior Requirements Engineer

Universal Diagnostics; United States; Hybrid; USD 90,000 - 120,000; Full time

Benefits offered by this job

22 days PTO with possibility to carry over 10 days

Flexible work schedule

Company-sponsored benefit plans including medical, dental, vision insurance

Job summary

Universal Diagnostics is seeking a Senior Software Requirements Engineer to support the development of innovative software solutions for early cancer detection technologies. You will work in a collaborative environment, ensuring regulatory compliance with IEC standards and FDA design controls, addressing critical responsibilities in software requirements engineering.

The ideal candidate has demonstrated expertise in managing software requirements for Class III medical devices, and will play a vital role in our mission to detect cancer at its earliest stages.

Qualifications

• 3+ years in managing software requirements for Class III medical devices.
• 5+ years in software requirements analysis or related activities.
• Experience with IEC 62304 and FDA design controls.
• Experience supporting risk management aligned with ISO 14971.
• Experience in Computer System Validation (CSV) or Computer Software Assurance (CSA).

Responsibilities

• Develop and maintain software and system requirements for regulated IVD software.
• Ensure end-to-end traceability and compliance with software lifecycle expectations.
• Support risk management activities with QA and cross-functional teams.
• Collaborate on Computer System Validation and compliance documentation.
• Participate in inspection support activities for regulated environments.

Skills

Software requirements analysis

Regulatory compliance

Traceability management

Risk management

Technical writing

Education

Bachelor's, Master’s, or Ph.D. in Engineering, Computer Science, Bioinformatics or related

Tools

Requirements management tools (Polarion, Jama Connect, IBM DOORS)

Job description

About our Company:

Universal DX, Inc is an international Company with a highly experienced team focused on cracking cancer’s code. Through our multi-omics and bioinformatics models, we have figured out how to read the disease’s signals in blood with high accuracy to detect cancer in its earliest stages. Starting with a colorectal cancer screening liquid biopsy test, we are building a multi-cancer platform that can identify the unique DNA regions associated with different types of cancers.

The Opportunity:

Universal DX, Inc is seeking an experienced Senior Software Requirements Engineer to join our growing team. In this role, you will work directly with the Sr. Director of Software Lifecycle and Compliance and play a critical role in supporting the development of next-generation bioinformatics, computational biology, and laboratory automation software in compliance with IEC 62304, ISO 14971, FDA design controls, and Computer System Validation (CSV)/Computer Software Assurance (CSA) expectations for Class III (PMA) medical devices and IVD systems.

You will contribute as a key technical individual contributor focused on software requirements engineering, traceability, risk alignment, and verification readiness across software and automation workflows supporting early cancer detection technologies.

You will be part of a team that is passionate about developing novel diagnostic tests for the early detection of cancers. As part of the team, you will be in a Company that aims more than to become one of the leaders in the industry. We want to have a huge positive impact on society by achieving the ambitious purpose of “making cancer a curable disease by detecting it earlier”.

How you’ll contribute:

Requirements & Traceability Engineering

• Develop, refine, review, and maintain software and system requirements for regulated IVD software, bioinformatics pipelines, computational biology platforms, laboratory automation systems, and supporting validated software tools in alignment with IEC 62304 and FDA expectations for Class III medical devices
• Ensure end-to-end traceability
• Support the maintenance of traceability matrices and associated design control documentation within requirements management tools
• Ensure requirements are testable, unambiguous, compliant, and aligned with software lifecycle and validation expectations

Risk Management Support

• Collaborate with QA and cross-functional teams to support risk management activities aligned with ISO 14971 and FDA expectations
• Support traceability

Computer System Validation (CSV) & Compliance Support

• Support Computer System Validation (CSV) and/or Computer Software Assurance (CSA) activities for software systems supporting laboratory, automation, bioinformatics, and quality workflows
• Collaborate with QA, laboratory, and software teams to support validation documentation
• Support compliance activities associated with 21 CFR Part 11, electronic records, data integrity, and validated laboratory software systems
• Participate in validation readiness and inspection support activities for regulated laboratory and software environments

Cross-Functional Collaboration

• Cross-Functional Collaboration

What you’ll bring:

Required Qualifications

• Bachelor’s, Master’s, or Ph.D. degree in Engineering, Computer Science, Bioinformatics, Computational Biology, Biology, or a related technical discipline
• 3+ years of experience creating and managing software requirements for Class III (PMA) medical device software or regulated IVD systems
• 5+ years of experience in software requirements analysis, systems engineering, business analysis, software compliance, or related healthcare software development activities
• Experience with IEC 62304 software lifecycle processes and FDA design controls for medical device software
• Experience supporting risk management activities aligned with ISO 14971
• Experience supporting Computer System Validation (CSV) and/or Computer Software Assurance (CSA) activities in regulated healthcare, laboratory, or medical device environments
• Prior experience supporting bioinformatics pipelines, computational biology software, laboratory automation workflows, or validated laboratory software systems in a regulated environment
• Experience collaborating cross-functionally with software engineers, computational biologists, automation engineers, QA, V&V, and R&D stakeholders
• Strong technical writing, analytical, and traceability management skills

Preferred Qualifications

• Prior experience supporting PMA submissions or FDA regulatory inspections
• Experience with In Vitro Diagnostic (IVD) medical devices and CLIA laboratory environments
• Familiarity with 21 CFR Part 11 and data integrity expectations for validated software systems
• Experience with requirements management and traceability tools such as Polarion, Jama Connect, or IBM DOORS
• Familiarity with laboratory automation workflows, sequencing pipelines, or NGS-based diagnostic systems
• Understanding of software verification and validation methodologies in regulated environments
• Ability to rapidly learn and support new technical domains and software functionality

What we´ll offer:

We’re proud to offer exceptional corporate benefits which include:

• 22 days of PTO with the possibility to carry over 10 days to the following year.
• Company Holidays, plus your Birthday off!
• Company-sponsored benefit plans, including medical, dental, and vision insurance plus life, STD, and LTD coverage, and 401(k).
• Flexible work schedule
• And more to come!

Why Now?

This is an exciting time to be at Universal DX. We are growing rapidly and starting our US operations by building up our team, starting our lab and business operations, and establishing strategic partnerships.

We are looking for passionate changemakers to be a part of our journey in this expansive time for us.