Software Systems Engineering (SSE)

Software Systems Engineer

Job Summary

This role is responsible for the following as they relate to complex medical devices and their associated software applications:

• Develop clear, concise software requirements, behavior, and feature definition
• Participate in software planning and estimation
• Requirements allocation and traceability
• Software integration strategy and planning
  
  

Essential Duties

Project:

• Lead simple programs or support more senior associates on large programs consisting of several software development teams including global partner teams with limited oversight.
• Define software behavior (requirements, environment, performance, etc.) for complex medical devices using a hybrid Waterfall-Scrum software development methodology, balancing structured planning with iterative development to meet project timelines while ensuring adherence to quality standards and customer requirements.
• Gather and prioritize scope inputs, with support from more senior associates, from diverse stakeholders including Business Area Leaders, Platform Tech Leads, Systems Engineering, Innovation, Software Development, Marketing, and Cybersecurity Teams. Define system behavior, use environment, requirements, feature definition, use case scenarios, full error paths, corner cases, and design constraints to ensure comprehensive project scope and functionality that meets customer needs.
• Collaborate effectively with multidisciplinary teams (systems engineering, software engineering, marketing, commercialization, regulatory affairs, quality assurance) to achieve customer requirements, design control objectives, and regulatory standards.
• Obtain formal cross-functional agreement of scope and priority of each project scope subset prior to starting software design and development with support from more senior associates.
• Manage scope changes throughout the project lifecycle with support from more senior associates.
• Collaborate with UI/UX designers, customer-facing associates, and human factors to create and optimize user interface design.
• May visit customer sites to gain firsthand knowledge of how users interact with the system in their environment and to determine customer needs.
• Work with software architects to define system behavior, allocate requirements, and review architectural design documentation with support from more senior associates.
• Collaborate with software architects to ensure functional and non-functional requirements are allocated to design elements and architecture with support from more senior associates.
• Own the interface control document which includes all software interfaces with support from more senior associates.
• Develop the integration test strategy and planning for a project with support from more senior associates. Ensure that integration points are satisfied before moving forward.
• Enforce project stage gates to ensure design controls adherence and best software lifecycle practices with support from more senior associates.
  
  

Process:

Contribute to meaningful, efficient, and consistent processes. Assist in identification of potential improvements.

Behaviors:

• Ability to identify, communicate, and propose mitigations to project risks that may impact delivery timelines.
• Consistently deliver high-quality results and meet deadlines.
• Deep end-to-end, hands-on knowledge of complex systems and their field applications including all system domains, i.e. hardware, software, disposables, labeling, embedded software, and interfacing software applications. Become a go-to person and system subject matter expert.
  
  

Minimum Qualification Requirements

Education

Bachelor of Science degree in Computer science or Engineering or other science (e.g. chemistry, physics, biology).

Experience

• Minimum 2-5 years of experience in developing medical device software compliant with IEC 62304:2006 / AMD 1:2015 Software life cycle processes for medical devices standard. Development of software to a similar standard or level of rigor also acceptable (e.g. aerospace).
• Knowledge of risk management processes, including FMEA (Failure Mode and Effects Analysis). Expertise in utilizing FMEA to analyze potential failure modes, prioritize risks, and develop robust mitigation strategies. Functional knowledge of ISO 14971:2019 Application of risk management to medical devices standard.
• Experience in defining and documenting system and subsystem requirements for systems and software solutions. Proficient in adhering to ISO/IEC/IEEE 29148:2018 Systems and software engineering standard to ensure comprehensive and structured requirements engineering.
• Familiar with requirements traceability management tools to manage requirements and traceability between requirements, design elements, software test artifacts, interface controls, risk control measures, and outputs.
  
  

Skills

• Attention to Detail: Meticulous attention to detail in all tasks and projects.
• Behavioral Modeling: Consistently model exceptional behaviors, contributing to a positive and productive work environment.
• Collaboration and Team Contribution: Skilled in fostering open communication and collaboration.
• Communication and Presentation: Clear communication and effective presentation skills.
• Communication Skills: Superior written and verbal communication abilities.
• Critical Thinking: Apply critical thinking skills to analyze problems.
• Decision-making and Problem Solving: Proficient in identifying and resolving issues promptly.
• Effective Communication: Proven ability to communicate effectively both verbally and in writing.
• Lab environment: Should not be sensitive to the sight or discussion of blood or needles. Both human and bovine blood is used where necessary, in addition to visiting customer sites where our equipment is used in a clinical or donor environment.
• Listening and Observational Skills: Strong listening and observational skills.
• Organizational and Time Management: Excellent time management skills.
• Ownership and Follow-through: Proactively pinpoint and take ownership of issues.
• Resource Utilization: Skilled in identifying resources effectively to optimize outcomes.
• Self-directed: Able to work independently, demonstrating initiative and self-motivation.
• Software Development Lifecycle: Knowledge of the software development lifecycle (SDLC), from planning and development through to deployment and maintenance.
• Subject Matter Expertise: Exhibit a solid, hands-on understanding of the subject matter and systems supported.
• Technology Proficiency: Knowledge and effective use of relevant PC software applications and skills to use them effectively.
  
  

Work Ethic: Strong work ethic characterized by dedication and reliability in team-based settings.