JOB TITLE: Principal Program Software Systems Engineer
JOB SUMMARY
This position is primarily concerned with software product definition across multiple product platforms and systems. It will work to translate users' needs, commercial desires, regulatory and technical standards into use cases, workflows, user stories, and UI mockups, and software specifications for multiple software development teams. This role is accountable for developing clear, concise software product development direction and requirements for complex medical devices and their associated software applications. This role must understand the goals of the end user and develop in-depth product expertise for multiple platforms, both from the user and technical perspectives. Working in a regulated industry, this role must adhere to design controls procedures and help teams to execute software development while generating evidence needed for regulatory submissions/audits. This role will work with cross-functional teams to help make trade-off decisions between development effort, required functionality, and end user experience. This role is accountable for establishing and maintaining alignment with the product/platform roadmap for a system of systems, providing vision and direction to software development teams throughout large scale projects.
ESSENTIAL DUTIES
Leads and is accountable for project deliverables, project definition, and technical execution.
Guides the successful completion of major programs and functions in a project leadership role.
Independently lead large complex programs consisting of several software development teams including global partner teams. May also support multiple platforms or projects simultaneously.
Gather and prioritize scope inputs 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.
Manage scope changes throughout the project lifecycle and lead impact assessments.
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.
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.
Work with software architects to define system behavior, allocate requirements, and review architectural design documentation. Collaborate with software architects to ensure functional and non-functional requirements are allocated to design elements and architecture.
Collaborate with software developers to further define lower level software specifications.
May visit customer sites to gain firsthand knowledge of how users interact with the system in their environment and to determine customer needs.
Collaborate with UI/UX designers, customer-facing associates, and human factors to create and optimize user interface design. Help drive consistency of product design and implementation across related platforms.
Recognize opportunities to share or reuse design and implementation between platforms, leveraging common components to realize faster product development.
Identify hazards, develops mitigations, and performs FMEA risk analysis as part of a cross-functional team of subject matter experts.
Provide mentoring and work direction to more junior software system engineers.
Owner of the interface control document which defines all interfaces with software, e.g., embedded to applications, software to hardware.
Develop integration test strategy and planning for a project with input from software development to ensure all interfaces are successful including software to hardware and embedded software to software applications to ensure that integration points are satisfied before moving forward.
Enforce project stage gates to ensure design controls adherence and best software lifecycle practices.
Works on complex issues where analysis requires an in-depth evaluation of variable factors. Exercises judgment in selecting methods, techniques and evaluation criteria for obtaining results.
Keeps updated on recent technical advances within the industry and applies this knowledge to products and processes.
OTHER DUTIES AND RESPONSIBILITIES
Interface and integrate with cross-functional teams (both non-R&D and R&D) to drive process improvements and strategic initiatives. Independently drive for meaningful, efficient, and consistent processes consistent with organizational strategic direction across multiple projects. Drive continuous improvement efforts and portions of the organization strategy.
Communicates effectively with a wide variety of cross-functional marketing, regulatory, quality, engineering and scientific groups (both verbally and in writing) on a broad range of complex issues.
Works closely with customers, clinical support, sales, and marketing to ensure alignment with customer needs.
Works across the software development organization to identify and manage cross-dependent projects and resources.
Assist with product support escalations, including technical analysis and characterization of issues.
Partner with Tech Comm team as a SME for customer-facing strings, user guide and training development
MINIMUM QUALIFICATION REQUIREMENTS
Education
Bachelor of Science degree in Computer science or Engineering or other science (e.g. chemistry, physics, biology).
Experience
Minimum 8 years experience.
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).
Strong background in 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.
Extensive experience in defining and documenting system and subsystem requirements for complex 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.
Expert in requirements and artifact (design docs, test plans, verification evidence, etc.) traceability management tools to manage requirements and traceability between requirements, design elements, software test artifacts, interface controls, risk control measures, and outputs.
Demonstrated success delivering large complex projects across the entire lifecycle.
Demonstrated leadership in software development project success.
Preferred: Experience in medical device and/or medical application SW development, including design controls deliverables required for regulated products.
Skills
Leading Teams: Demonstrated ability to lead teams towards achieving project milestones and goals.
Behavioral Modeling: Consistently model exceptional behaviors, contributing to a positive and productive work environment and a culture of integrity and excellence.
Change Leader: Change leader who identifies opportunities for improvement and implements solutions to drive positive change.
Strategic Decision-making: Solve complex problems amidst significant ambiguity. Utilize analytical skills and judgment to navigate complex challenges and achieve optimal outcomes that align with organizational goals and project deliverables.
Subject Matter Expertise: Exhibit a solid, hands-on understanding of the subject matter and systems supported.
Technical Recommendations: Capable of making and defending solid technical recommendations based on thorough analysis and understanding.
Decision-making and Problem Solving: Proficient in identifying and resolving issues promptly. Make timely decisions involving appropriate stakeholders, ensuring efficient problem resolution and project execution.
Organizational and Time Management: Excellent organizational and time management skills and proper prioritization, ensuring efficient workflow and deadlines consistently met.
Ownership and Follow-through: Proactively pinpoint and take ownership of issues, including thorough follow-through to resolution. Attention to Detail: Meticulous attention to detail in all tasks and projects.
Communication and Presentation: Clear communication and effective presentation skills, capable of delivering technical information to both technical and non-technical audiences and adept at responding to inquiries from various stakeholders.
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.
Regulatory and Technological Acumen: Proficient in navigating and managing challenges posed by rapidly evolving medical regulatory criteria and evolving software technologies, ensuring compliance and innovation.
Demonstrated in-depth knowledge of complex products and systems, and systems of systems.
Software Development Lifecycle: Extensive knowledge of the software development lifecycle (SDLC), from planning and development through to deployment and maintenance.