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 complex 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 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.
• Determine and enforce high level ordering of activities and feature sets to deliver project scope subsets to the software development teams.
• Obtain formal cross-functional agreement of scope and priority of each project scope subset prior to starting software design and development.
• Manage scope changes throughout the project lifecycle. For mid-project requirements changes, lead and conduct impact assessments on the requirements; requirement allocation; integration strategy; and project impacts. Participate in impact assessments on the requirements flow; verification strategy, plan or protocols; and existing design and development work.
• 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.
• May visit customer sites to gain firsthand knowledge of how users interact with the system in their environment and to determine customer needs.
• Skilled in estimating project delivery dates through collaborative efforts with software development and verification teams, ensuring on-time delivery within budget.
• 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.
• Owner of the interface control document which includes all interfaces with software, e.g., embedded to applications, software to hardware.
• Develop the integration test strategy and planning with input from software development to ensure all interfaces are successful. Ensure that integration points are satisfied before moving forward.
• Enforce project stage gates to ensure design controls adherence and best software lifecycle practices.
• Support junior software systems engineering associates on projects and project tasks.

Process:

Interface and integrate with cross-functional teams (both non-R&D and R&D) to drive process improvements. Deliver content for meaningful, efficient, and consistent processes. Regularly identify potential improvements and contribution the organization strategy.

Behaviors:

• Provide clear solutions to complex, ambiguous problems.
• Support, mentor, and model good behavior to more junior software systems engineers. Perform peer reviews on other programs.
• Ability to identify, communicate, and mitigate project risks that may impact delivery timelines.
• Consistently deliver high-quality results and meet deadlines.
• Take initiative, full ownership of responsibilities, and personal accountability to drive progress and achieve aggressive goals.
• Continuously seek to expand knowledge and skills.
• Communicate effectively, collaborate well with others, maximize productivity, and align work with the organization's strategic goals.
• 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 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).
• 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.
• 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 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.

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 and a culture of integrity and excellence.
• Change Leader: Change leader who identifies opportunities for improvement and implements solutions to drive positive change.
• Collaboration and Team Contribution: Skilled in fostering open communication and collaboration, encouraging input from others and contributing to a positive team environment.
• 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.
• Communication Skills: Superior written and verbal communication abilities, ensuring clear and effective communication of complex information across diverse audiences.
• Critical Thinking: Apply critical thinking skills to analyze problems and develop innovative solutions.
• 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.
• Effective Communication: Proven ability to communicate effectively both verbally and in writing, fostering strong relationships and clear understanding.
• 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.
• Leading Teams: Demonstrated ability to lead teams towards achieving project milestones and goals.
• Listening and Observational Skills: Strong listening and observational skills, able to quickly grasp audience needs and adjust communication style accordingly.
• 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.
• 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.
• Resource Utilization: Skilled in identifying and leveraging resources effectively to optimize outcomes.
• Self-directed: Able to work independently, demonstrating initiative and self-motivation.
• Software Development Lifecycle: Extensive knowledge of the software development lifecycle (SDLC), from planning and development through to deployment and maintenance.
• Strategic Decision-making: Solve complex problems amidst significant ambiguity.
• 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.
• 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.