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Principal Engineer at Baxter International - ApplyBlast

Principal Engineer

Baxter International

4 months ago

Round Lake, Illinois

Hybrid

Full Time

Senior

0 applicants

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About this role

The Risk Engineer leads risk management activities for infusion pump systems throughout the product lifecycle to ensure patient and user safety. Responsibilities include identifying hazards, assessing risks, implementing mitigation strategies, and collaborating with cross-functional teams to integrate risk management into design and post-market activities while adhering to ISO 14971 standards.

Responsibilities

Lead risk management activities in accordance with ISO 14971 standards
Identify mechanical, electrical, software, usability, and cybersecurity-related hazards
Collaborate with cross-functional teams to incorporate risk controls
Perform robust risk impact assessments of issue records and trends
Train and mentor team members on risk management principles and tools

Skills

Qualifications

Bachelor's degree in Biomedical, Mechanical, Electrical, Systems Engineering, Computer Science, or related field5+ years of experience in medical device risk management or product developmentWorking knowledge of ISO 14971 and related standardsExperience with risk analysis tools (FMEA, FTA, hazard analysis)Proficiency in bug tracking tools and requirements management tools

About Baxter International

baxter.com

Headquarters

Deerfield, Illinois, United States

Company Size

10001+ employees

Founded

1931

View Profile

Baxter International is a global healthcare company that develops and provides medical devices, connected solutions, and advanced injectable technologies for hospitals, physician offices, and home care settings. Their product portfolio spans primary care, hospital care, surgical care, nutritional care, and respiratory health. For nearly a century, Baxter has been committed to saving and sustaining lives by partnering with healthcare professionals and patients to deliver smarter, more personalized care.