Principal Systems Engineer – Medical Devices & NPD Risk

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

Benefits offered by this job

Flexible workplace policy

Discretionary bonuses

Equitable pay practices

Job summary

Baxter International Inc. is seeking a Principal Systems Engineer to sustain and develop products in the Front-Line Care Connected Monitoring portfolio.

You will own systems and risk activities for NPD products, collaborating across functions to influence outcomes and deliver robust, compliant solutions. The role emphasizes translating needs into requirements, leading risk management, and coordinating a multi-disciplinary team to ensure deliverables meet high standards and regulatory

Qualifications

• Bachelor’s Degree in Mechanical, Electrical, Software Engineering or comparable technical discipline.
• 5 to 6+ years of engineering experience.
• Knowledge in ISO 14971 Application of Risk Management to Medical Devices.
• Knowledge in IEC 62304 and IEC/TR 80002-1.
• Strong interpersonal and written communication skills.
• Ability to plan, estimate and track deliverables.

Responsibilities

• Translate customer needs, business constraints, and regulatory requirements into system requirements.
• Conduct risk management activities including planning, risk analysis, risk evaluation and control.
• Decompose system requirements into module-level requirements.
• Plan and oversee reliability and robustness activities.
• Lead the technical team through risk identification, management, and defect resolution.
• Ensure changes are analyzed holistically and impacts understood.

Skills

Systems engineering

Risk management

Medical devices knowledge

Regulatory knowledge

Communication

Decision making

Education

Bachelor's degree in engineering

Job description

Baxter International Inc. is seeking a Principal Systems Engineer to sustain and develop products in the Front-Line Care Connected Monitoring portfolio.

You will own systems and risk activities for NPD products, collaborating across functions to influence outcomes and deliver robust, compliant solutions. The role emphasizes translating needs into requirements, leading risk management, and coordinating a multi-disciplinary team to ensure deliverables meet high standards and regulatory