Principal Engineer (Electrical)

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

The Principal Engineer performs Electrical Engineering tasks for the life-cycle management for on-market products manufactured at the production unit of active and non-active hardware medical devices, software, and laboratory equipment. This includes maintaining design requirements, design specifications, and risk management documentation; performing electrical testing; supporting verification and validation activities. This also includes performing technical and problem-solving activities to analyze and resolve field and manufacturing product issues. Requires working in a team environment with cross-functional team members, such as manufacturing, quality, regulatory, and other R&D departments.

Please note: This position cannot provide employment-based immigration sponsorship now or in the future. Applicants must be currently authorized to work in the United States for any employer and must be able to maintain that authorization for the entire duration of employment without requiring employer sponsorship at any time, including in the instance when your current work authorization expires. We ask that candidates answer all work authorization questions fully and accurately during the application process.

Responsibilities

• Engineer with Purpose – Drive the design, development, integration testing, and root cause analysis of complex electronic systems to meet critical product requirements and business goals.
• Solve Real-World Problems – Apply sound engineering principles, computational tools, and creative problem-solving to tackle technical challenges and ensure quality across the product life cycle.
• Advance Automation – Collaborate on the design, deployment, and continuous improvement of smart automation tools that power the production of cutting-edge medical devices.
• Design for Innovation – Work with cross-functional teams to develop custom test fixtures and specialized hardware to support product validation and manufacturing.
• Lead Critical Investigations – Take ownership of in-depth failure analysis for field and production issues, including component faults, ESD, soldering, and EMI.
• Ensure Continuity and Compliance – Evaluate supplier changes, assess part obsolescence, and lead requalification efforts for electrical components.
• Be the Voice of the Customer – Analyze field return data, address customer complaints, and contribute to CAPA activities to ensure reliable and safe product performance.

All employees are responsible for ensuring the compliance to company documents, programs and activities related to the Health, Safety, Environment, Energy, and Quality Management Systems, as per your roles and responsibilities.

Requirements

• Bachelors degree in Electrical Engineering and/or Engineering degree with 5-7 years of relevant experience in automated test fixtures.
• Proficiency in automation and data analysis software, like Python, LabView, and MATLAB
• Experience with troubleshooting hardware and software issues in a production environment
• Diagnose and resolve failures: PCBs, connectors, cables, sensors, batteries, power management circuits.
• Experience with electrical design tools: Altium, PSpice, oscilloscopes, signal generators, etc.
• Familiar with appropriate FDA QSR and ISO regulations: IEC 60601, design controls, document controls, design verification and validation.
• Must possess a firm foundation in the basic principles of their respective engineering discipline.
• Able to manage projects, coordinate contractors, and direct the activities of a technician.
• Excellent verbal and written communication skills.
• The Company’s primary business language is English. The successful candidate must be able to effectively speak, read, write, and understand English to perform the essential functions of the position, including independently understanding policies, procedures, training materials, and workplace communications written in English due to our heavily regulated work environment.

Additional Information

Salary Range: $100,000 to $120,000

Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities. Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most.

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company contribution, and wellness program.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.