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Siemens Healthineers · 4 hours ago

Systems Engineer, Requirements Engineering

Walpole, MA

Full-time

Onsite

Senior Level, Lead/Staff

$123K/yr - $169K/yr

8+ years exp

Siemens Healthineers is a leader in medical technology, dedicated to pioneering breakthroughs in healthcare. The Systems Engineer (Requirements Engineering) will lead requirements definition across software, assay, and other subsystems while engaging with stakeholders to drive efficient development and manage requirements throughout the lifecycle.

Health CareHealth DiagnosticsMedicalMedical Device

Responsibilities

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 tradeoff 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

Qualification

Systems Engineering principlesRequirements gatheringMedical device software developmentIBM DOORSAzure DevOpsRisk managementTechnical writingCollaboration skillsCommunication skillsAttention to detailTime management

Required

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

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

Proficient in tools and processes related to requirements and systems engineering, including IBM DOORS, and Azure DevOps

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

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 ISO13485, IEC62304, and ISO14971

Working knowledge of requirements management tools such as DOORS, or similar

Proficiency with Microsoft Office Suite and Azure DevOps

Preferred

Familiarity with critical care or primary care assays is a plus

Experience with SAP is a plus

Benefits

Medical insurance

Dental insurance

Vision insurance

401(k) retirement plan

Life insurance

Long-term and short-term disability insurance

Paid parking/public transportation

Paid time off

Paid sick and safe time

Company

Siemens Healthineers

Glassdoor4.1

Siemens Healthineers is a healthcare technology company that provides diagnostic and therapeutic products and services. It is a sub-organization of Siemens.

Founded in 1847

Malvern, Pennsylvania, USA

10001+ employees