Senior Electrical Engineer - Medical Devices & Automation

Fresenius Kabi USA; Warrendale (Allegheny County); On-site; USD 100,000 - 120,000; Full time

Benefits offered by this job

Medical, dental, and vision coverage

Life insurance

Disability insurance

401K with company contribution

Wellness program

Job summary

Fresenius Kabi USA seeks a Principal Engineer to lead electrical engineering activities for life-cycle management of on-market hardware medical devices, software, and lab equipment. You will maintain design requirements, design specifications, and risk management documentation, and support verification/validation activities.

You will collaborate with cross-functional teams across manufacturing, quality, regulatory, and R&D to analyze field issues and drive improvements ensuring safe, reliable

Qualifications

• Bachelor's degree in Electrical Engineering.
• 5–7 years of relevant experience in automated test fixtures.
• Experience troubleshooting hardware and software in a production environment.
• Familiar with FDA QSR and IEC 60601 design controls.

Responsibilities

• Drive design, development, integration testing, and root cause analysis of complex electronic systems.
• Apply engineering principles and data tools to tackle technical challenges and ensure quality across the product life cycle.
• Advance automation tooling powering production of medical devices.
• Develop test fixtures and specialized hardware to support validation and manufacturing.
• Lead investigations into field and production failures (ESD, soldering, EMI).
• Evaluate supplier changes and manage component requalification.
• Analyze field data and CAPA to ensure product reliability.

Education

Bachelor's degree in Electrical Engineering

Tools

Python

LabVIEW

MATLAB

Job description

Fresenius Kabi USA seeks a Principal Engineer to lead electrical engineering activities for life-cycle management of on-market hardware medical devices, software, and lab equipment. You will maintain design requirements, design specifications, and risk management documentation, and support verification/validation activities.

You will collaborate with cross-functional teams across manufacturing, quality, regulatory, and R&D to analyze field issues and drive improvements ensuring safe, reliable