Systems Engineer, Requirements Engineering

Systems Engineer, Requirements Engineering

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• Leading requirements definition across software, assay, and other subsystems.
• Defining and analyzing use cases and user stories in alignment with business objectives, Design Input Requirements, and system design.
• Driving software requirements through E&E, interviews, document analysis, requirements workshops, hands‑on product experience, and workflow analysis.
• Independently engaging with internal and external stakeholders across commercial, marketing, usability, assay development, and systems engineering to inform and drive efficient subsystem, assay, and software development.
• Collaborating with UX on workflow and GUI definition, including analyzing competitive and legacy product workflows, edge cases and exceptions/error conditions.
• Guiding technical discussions to assess ability of common platform solutions to meet software requirements.
• Writing clear, testable subsystem requirements using standard templates.
• Supporting subsystem risk management activities by facilitating risk and test tracing to subsystem requirements.
• Controlling changes to baselined requirements and supporting impact analysis for proposed changes, bug fixes, or new features.
• Identifying and resolving requirements conflicts, facilitating prioritization, driving trade‑off analyses and proactively managing requirements to achieve project objectives.
• Managing requirements throughout the development lifecycle, maintaining traceability in DOORS, and linking subsystem requirements to DIRs, specifications and tests.
• Leading peer reviews and design reviews of requirements documents; identifying and remediating requirements errors and defects.
• Supporting technical reviews of design, implementation, and test to assess compliance to subsystem requirements.
• Tracking and reporting progress to teams and stakeholders verbally and in writing.

• Knowledge of Systems Engineering principles and best practices. Experience in requirements gathering, analysis, and documentation for complex systems.
• Solid understanding of medical device software development and risk management processes.
• Demonstrated ability to work independently as well as part of a cross‑functional product development team.
• Facilitation skills to lead and drive discussions with technical and commercial stakeholder groups to elicit information to inform requirements.
• Proficiency in tools and processes related to requirements and systems engineering, including IBM DOORS, and Azure Dev Ops.
• Excellent collaboration and communication skills for interfacing with multiple stakeholders, interdisciplinary teams, distributed teams, and external development partners.
• Proficiency in creating clear, consistent, and testable user stories, acceptance criteria, and documentation.
• Excellent technical writing, communication, and presentation skills.
• Good attention to detail and the ability to recognize discrepancies; aspiration for technical excellence.
• Strong organization and time management skills; experience tracking and reporting progress using data‑driven dashboards.
• Proven track record of delivering quality results in a resource‑constrained environment.

• Degree in Systems Engineering, Software Engineering or related field plus 8+ years’ experience in a systems engineering role supporting product development in the life sciences or healthcare industry.
• Experience driving systems engineering activities at the subsystem level (e.g., requirements, verification/validation, design and test traceability, risk management).
• Familiarity with in vitro diagnostic device development processes including ISO
  13485, IEC
  62304, and ISO
  14971.
• Familiarity with critical care or primary care assays is a plus.
• Working knowledge of requirements management…