Senior Principal Systems Engineer

Responsibilities Manage and own the technical roadmap for product families, integrate technical roadmaps with Upstream Marketing product roadmaps Work with Program Management, Upstream Marketing and Customers to plan new development, initiate product change activities, understand & translate market needs into technical product requirements & workflows Work with cross functional team members (e.g., Marketing and Clinical personnel) to translate user needs into system requirements Serve as liaison VOC from Marketing to Engineering Work with Engineering Project Management to define and scope projects to achieve program goals Participate as a member of project teams for the assigned program Lead development of Design Inputs and Digital Interface Requirements Develop User and Clinical Workflows to drive requirement analysis Own System Architecture Lead engineering resources (Electrical, Mechanical, and Software) in the decomposition of system requirements to derived requirements Contributes to resolution of competing constraints among inter-related functions (e.g., engineering, manufacturing, regulatory, marketing) required to deliver products to market Lead Decision Making using tools such as Decision Matrices to evaluate trade-offs Resolves interface issues and have the ability to document theory of operations of complex medical product designs Work with verification engineers to define test strategies for the development of verification plans and validation plans using requirement tracing methods Owner of the Design History File (DHF) Responsible for ensuring technical product requirements are clearly & thoroughly documented, and verified & validated This includes the following: Ensures usability requirements are adequately incorporated per IEC 62366 Lead technical resource for Risk Management analysis activities per IEC 14971 including capturing hazards, mitigations, and residual risk determination Lead Coordination and review of system and design level requirements to ensure they adequately meet system requirements, market needs, serviceability and manufacturability of the product Member of multi-functional support team; duties as needed include serving as critical issue point-person, lead product support meetings, participate in CAPA activities, assist with complaint & post-market investigations Oversee platform-based product designs that meet needs for multiple portfolios by coordinating shared needs and requirements Requirements Bachelor’s Degree (Mechanical, Electrical, Software, Biomedical Engineering or comparable technical subject area) 8+ years' of engineering experience on medical devices Knowledge in ISO 14971 Application of Risk Management to Medical Devices Knowledge of IEC 60601 Safety Compliance of Medical Devices Ability to apply systems engineering principles in Agile SAFe framework by supporting the Product Owner in Epic, Feature and Story development/definition and backlog prioritization Experience using tools such as MATLAB (MBSE), Azure DevOps, Polarion, Trackwise preferred Strong interpersonal skills with the ability to lead and work collaboratively with others in a team environment Able to work in the absence of complete information and make timely decisions performing with great attention to detail Excellent verbal and written communication, especially relating to clear, concise, and verifiable requirements Strategic problem solver, organized and able to progress on many different tasks in parallel Able to plan, estimate and accurately track deliverables Fundamental understanding of Hardware & Software engineering Adaptive, open to change and continuously looks for ways to improve and simplify sophisticated work Prior experience on Resting ECG devices (AFE, Cardiographs) is a plus. #J-18808-Ljbffr