Principal Engineer (systems, Requirements)

Fresenius Kabi

Remote, US
Base: $105,000 - $115,000; bonus: target 8% of bas...
Fully remote
System and subsystem requirements development
Regulated industry product development experience
Cross-functional collaboration in r&d
Fresenius Kabi is seeking a Principal Engineer specializing in systems and requirements for their infusion systems division, which is a fully remote position. The role entails developing and managing system-level requirements for FDA-governed medical devices and collaborating cross-functionally to ensure compliance and performance throughout the product lifecycle

Job Summary

  • The Principal Engineer is responsible for developing system-level assessments and documentation for the Ivenix Infusion System throughout its product lifecycle.
  • This role requires collaboration with engineering, quality, regulatory, and cyber security teams to ensure holistic systems development satisfying customers and agencies.
  • The position offers a comprehensive benefits package including a 401(k) plan with company contributions, paid vacation, and full health coverage.

Matching Summary

Match Score: 85

Fresenius Kabi is seeking a Principal Engineer specializing in systems and requirements for their infusion systems division, which is a fully remote position. The role entails developing and managing system-level requirements for FDA-governed medical devices and collaborating cross-functionally to ensure compliance and performance throughout the product lifecycle.

Salary

Base: $105,000 - $115,000; Bonus: Target 8% of base salary; Benefits: 401(k), health, dental, vision, paid time off

Skills & Requirements

Must-have

  • System and subsystem requirements development
  • Regulated industry product development experience
  • Cross-functional collaboration in R&D

Nice-to-have

  • Strong verbal and written communication skills
  • Ability to operate independently with judgment
  • Knowledge of ISO 13485 and IEC62304 standards

Key Requirements

  • B.S. degree in Engineering or related field
  • Minimum 5 years of related experience
  • Experience with FDA governed medical devices
  • Authorized to work for any employer in the United States

Work Rights

Must be authorized to work for any employer in the United States

Tailored Resume

Cover Letter