Principal Systems Engineer, Medical Devices & Risk

Baxter International Inc.; Skaneateles Falls (NY); On-site; USD 112,000 - 154,000; Full time

Benefits offered by this job

Medical and dental coverage starts day

Employee Stock Purchase Plan (ESPP)

401(k) Retirement plan with company 1:

Paid holidays and PTO

Parental leave

Job summary

Baxter International Inc. is seeking a Principal Systems Engineer to sustain and develop Front-Line Care Connected Monitoring products throughout their lifecycle. You will own system and risk activities for NPD projects, guiding teams to meet regulatory and performance goals while delivering life-saving outcomes.

You will collaborate across R&D, ensure robust requirements, and lead technical risk management, with a focus on patient care improvements and cross-functional influence.

Qualifications

• Bachelor’s degree in a technical discipline and 5+ years of engineering experience.
• Knowledge of risk management in medical devices (ISO 14971).
• Familiarity with IEC 62304 and IEC TR 80002-1.

Responsibilities

• Translate customer needs and regulatory requirements into system requirements and performance specs.
• Conduct risk management activities including planning and control.
• Decompose system requirements into module level requirements.
• Plan and oversee reliability and robustness activities.
• Lead the technical team through risk identification and defect resolution.
• Ensure changes are analyzed holistically with full impact assessment.

Skills

Interpersonal skills

Planning & estimation

Requirements writing

Team leadership

Education

Bachelor’s Degree in Mechanical, Electrical, Software Engineering or similar

Tools

ISO 14971 Knowledge

IEC 62304 Knowledge

IEC TR 80002-1 Knowledge

Job description

Baxter International Inc. is seeking a Principal Systems Engineer to sustain and develop Front-Line Care Connected Monitoring products throughout their lifecycle. You will own system and risk activities for NPD projects, guiding teams to meet regulatory and performance goals while delivering life-saving outcomes.

You will collaborate across R&D, ensure robust requirements, and lead technical risk management, with a focus on patient care improvements and cross-functional influence.