Senior Requirements Engineer

About the role

You own the end-to-end software requirements engineering lifecycle for regulated medical device and laboratory automation software, translating complex bioinformatics and clinical workflows into precise, traceable requirements. You own collaboration with cross-functional stakeholders including computational biologists, bioinformaticians, software architects, validation specialists, and regulatory teams to ensure alignment with IEC 62304, ISO 14971, FDA design controls, and Computer System Validation expectations. You own the definition of software architectural constraints, functional specifications, and non-functional requirements that directly support multi-omics data interpretation and cancer detection algorithms. You own the development and maintenance of bidirectional traceability between requirements, risk controls, test cases, and source code within validated environments. You own the analysis of use cases and user workflows to derive robust functional and performance requirements for cloud-based and on-premise deployments. You own close coordination with quality assurance and regulatory affairs to ensure requirements stability, verification readiness, and auditability throughout the product lifecycle. You own the continuous refinement of requirements artifacts to accommodate evolving scientific insights and compliance obligations in a high-assurance development environment.

Key facts

What you'll do

Analyze complex bioinformatics and laboratory automation workflows to derive detailed functional and non-functional software requirements that satisfy IEC 62304, ISO 14971, and FDA design control regulations.

Develop and maintain comprehensive software requirements specifications, user stories, acceptance criteria, and use cases that clearly define intended system behavior for multi-omics and cancer detection platforms.

Establish and oversee bidirectional traceability between high-level product goals, software requirements, risk controls, verification activities, and source code to ensure compliance and audit readiness.

Collaborate with computational biologists and bioinformaticians to translate complex analytical algorithms and data models into precise, testable software requirements and performance criteria.

Partner with validation and quality teams to define verification strategies, boundary conditions, and acceptance testing approaches that demonstrate requirements fulfillment under validated conditions.

Support the creation of Computer System Validation (CSV) and Computer Software Assurance (CSA) artifacts, including risk analyses, design specifications, and change impact assessments for Class III medical device and IVD software.

Guide the definition of software architecture constraints, interface contracts, data formats, and security controls required for cloud-based and on-premise deployments in regulated environments.

Facilitate stakeholder reviews and design discussions to resolve ambiguities, manage scope, and ensure requirement stability across development sprints and regulatory milestones.

Monitor emerging regulatory guidance and industry standards, translating updates into actionable requirements engineering practices and process improvements.

Contribute to the development of training materials and process documentation that support consistent application of requirements engineering best practices across the development lifecycle.

Requirements

You possess a Bachelor's or Master's degree in Computer Science, Software Engineering, Bioinformatics, Computational Biology, or a closely related technical field that provides foundational knowledge of software development and life sciences data modalities.

You bring 8+ years of experience in software requirements engineering, systems engineering, or technical product definition for medical device, IVD, or regulated software environments.

You hold demonstrated expertise in IEC 62304, ISO 14971, FDA design controls, and Computer System Validation (CSV) / Computer Software Assurance (CSA) principles, with a clear understanding of how these frameworks apply to multi-omics and laboratory automation software.

You have substantial experience creating and managing bidirectional traceability between requirements, risk, verification, and source code using dedicated tools and versioned documentation.

You bring hands-on experience translating complex bioinformatics workflows, analytical pipelines, and data models into structured software requirements, acceptance criteria, and testable specifications.

You have a strong working knowledge of cloud and on-premise deployment architectures, data formats, security controls, and integration patterns relevant to regulated life sciences platforms.

You demonstrate exceptional written and verbal communication skills, with the ability to synthesize complex scientific and technical information into clear, precise requirements for cross-functional audiences.

You show a meticulous, detail-oriented approach to requirements definition, change management, and configuration control in high-assurance development environments.

Nice to have

Experience with colorectal cancer screening, liquid biopsy, or multi-cancer early detection platforms is preferred.

Familiarity with bioinformatics data pipelines, variant calling, and genomic data standards is advantageous.

Prior involvement in regulated software development for Class III medical devices or IVD systems is highly valued.

Practical notes

Hours: Full-time (40 hours per week).

Travel: None required.

Visa: Sponsorship is not available for this position at this time.

Deadlines: Please submit your application through the company portal by the closing date listed on the job posting.