Sr. Principal Systems Engineer

Baxter International Inc. • Milwaukee, WI

3d • $128,000 - $176,000 • Hybrid

About The Position

This position will understand and define customer needs; product functionality and performance requirements; product architecture, constraints and trade-offs; design and interface requirements, of new products being developed. You will support the overall design of the final product and responsible for all risk management activities to ensure a safe and effective product. As a Sr. Principal Systems Engineer, you will be a part of a multidisciplinary new product development team! Your work contributes directly to making a significant impact on others. It's challenging work—and you're not on your own. Our teams collaborate cross-functionally and lead by influence. Our colleagues within our R&D organization desire to work on products that make a meaningful difference in others' lives. We are motivated by the power of teamwork and are natural leaders who are skilled at influencing others!

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
• 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
• Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time.

Nice To Haves

• Experience using tools such as MATLAB (MBSE), Azure DevOps, Polarion, Trackwise preferred.
• Prior experience on Resting ECG devices (AFE, Cardiographs) is a plus.

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.
• 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, asist with complaint & post-market investigations.
• Oversee platform-based product designs that meet needs for multiple portfolios by coordinating shared needs and requirements.

Benefits

• medical and dental coverage that start on day one
• insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
• Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount
• 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
• Flexible Spending Accounts
• educational assistance programs
• paid holidays
• paid time off ranging from 20 to 35 days based on length of service
• family and medical leaves of absence
• paid parental leave
• commuting benefits
• Employee Discount Program
• Employee Assistance Program (EAP)
• childcare benefits

What This Job Offers

• Job Type: Full-time
• Career Level: Senior