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

• 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 Dev Ops, 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.