Principal Systems Engineer Job at Baxter (Skaneateles Falls)

Job Description

As a Principal Systems Engineer at Baxter, you will play a critical role in both the sustainment of currently marketed products and New Product Development (NPD) within the Front Line Care Exam Diagnostics portfolio. This role is responsible for leading system-level engineering and risk management activities, with ownership across the full product lifecycle.

Job Responsibility

Translate customer needs, business objectives, and regulatory requirements into clear, testable system-level requirements
Lead and execute risk management activities in accordance with ISO 14971
Decompose system-level requirements into subsystem and module-level requirements, ensuring traceability
Plan and oversee reliability and robustness activities to ensure product performance over time
Lead cross-functional teams in identifying and mitigating technical risks, resolving issues, and managing test defects
Evaluate product and design changes holistically to ensure impacts are fully assessed across system, regulatory, and business dimensions
Drive alignment across engineering, quality, and regulatory functions on system-level decisions and deliverables
Support adherence to Baxter product development processes, documentation expectations, and regulatory requirements

Requirements

Bachelor's degree in Mechanical, Electrical, Software Engineering, or a related technical discipline
5+ years of relevant engineering experience, preferably in medical devices or a regulated industry
Strong working knowledge of ISO 14971
Strong working knowledge of IEC 62304
Strong working knowledge of IEC/TR 80002-1
Demonstrated ability to lead through influence in a cross-functional team environment
Strong interpersonal and communication skills
Ability to make sound decisions in the absence of complete information and navigate ambiguity effectively
Strategic mindset with strong attention to detail and execution discipline
Proven ability to manage multiple priorities and deliverables in parallel
Strong problem-solving and critical-thinking skills
Experience planning, estimating, and tracking technical work
Solid understanding of both hardware and software development processes
Demonstrated ability to write clear, concise, and verifiable requirements
Adaptable and continuous improvement-oriented mindset, with a focus on simplifying complex processes
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.

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer
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
time-off benefits such as 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

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Principal Systems Engineer

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