Principal Engineer (Electrical)

301055 Fenwal, Inc.; Warrendale (Allegheny County); On-site; USD 100,000 - 120,000; Full time

Benefits offered by this job

Medical/dental/vision coverage

Life insurance, disability, 401(k)

Wellness program

Job summary

Fresenius Kabi in Warrendale, PA, is seeking a Principal Engineer to perform electrical engineering tasks for the life‑cycle management of medical devices and related hardware, software, and laboratory equipment.

This includes maintaining design requirements, design specifications, and risk management documentation; performing electrical testing; supporting verification and validation activities; and conducting technical problem‑solving to analyze field and manufacturing issues.

Qualifications

• Excellent verbal and written communication skills.
• Ability to manage projects, coordinate contractors, and direct the activities of a technician.

Responsibilities

• Drive the design, development, integration testing, and root cause analysis of complex electronic systems to meet critical product requirements and business goals.
• Apply engineering principles, computational tools, and problem-solving to tackle technical challenges and ensure quality across the product life cycle.
• Collaborate on the design, deployment, and continuous improvement of smart automation tools powering production of medical devices.
• Develop custom test fixtures and hardware to support validation and manufacturing.
• Lead in-depth failure analysis for field and production issues, including component faults, ESD, soldering, and EMI.
• Evaluate supplier changes, assess part obsolescence, and lead requalification of electrical components.
• Analyze field return data, address customer complaints, and contribute to CAPA activities to ensure reliable and safe product performance.

Skills

Communication skills

Project management

Education

Bachelor's degree in Electrical Engineering

Tools

Python

LabView

Matlab

Job description

Job Summary

Salary Range: $100,000 to $120,000 per year depending on education and experience.

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 maintain that authorization for the entire duration of employment without requiring employer sponsorship at any time.

We ask that candidates answer all work authorization questions fully and accurately during the application process.

The Principal Engineer performs Electrical Engineering tasks for the life‑cycle management of 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; and 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.

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.

Qualifications

• 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.
• Bachelor’s 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, such as Python, LabView, and Matlab.
• Experience with troubleshooting hardware and software issues in a production environment: diagnose and resolve failures involving PCBs, connectors, cables, sensors, batteries, and power‑management circuits.
• Experience with electrical design tools including Altium, Pspice, oscilloscopes, and signal generators.
• Familiarity with FDA QSR and ISO regulations: IEC 60601, design controls, document controls, design verification, and validation.
• Firm foundation in the basic principles of electrical engineering.
• Ability to manage projects, coordinate contractors, and direct the activities of a technician.
• Excellent verbal and written communication skills.

Benefits

• Medical, dental, and vision coverage.
• Life insurance, disability coverage, and a 401(k) plan with company contribution.
• Wellness program and other benefits as per company policies.

Employment Details

All employment is at‑will, meaning both the employee and Fresenius Kabi have the right to end the employment relationship at any time, in accordance with applicable federal and state laws.

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

Equal Opportunity Employer

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.