Principal Engineer (Electrical)

RXinsider LTD.; Northern (KY); Hybrid; 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 in the United States is seeking a Principal Engineer to lead electrical engineering activities across life-cycle management of medical devices and lab equipment. You will maintain design requirements, perform electrical testing, and support verification and validation in a cross-functional team environment.

The role emphasizes solving real-world problems, advancing automation, and ensuring compliance with FDA QSR and ISO 60601 standards, while delivering reliable product

Qualifications

• Bachelors degree in Electrical Engineering and/or related field.
• 5–7 years of experience with automated test fixtures.
• Proficiency in automation and data analysis software (Python, LabVIEW, MATLAB).
• Experience troubleshooting hardware and software in production.
• Familiar with FDA QSR and ISO IEC 60601 design controls.

Responsibilities

• Drive design, development, integration testing, and root cause analysis of complex electronic systems.
• Apply engineering principles to tackle technical challenges and ensure quality.
• Advance automation tools powering production of medical devices.
• Collaborate with cross-functional teams for design validation and manufacturing.
• Lead investigations into failures and ensure regulatory compliance.
• Analyze field data, support CAPA activities, and address supplier changes.

Education

Bachelor's degree in Electrical Engineering or related

Tools

Python

LabVIEW

MATLAB

Altium

Pspice

Oscilloscopes

Job description

Job Summary

********** SIGN-ON BONUS ***********

Salary Range: $100,000 to $120,000 per year, dependent upon education and experience, plus an annual target bonus opportunity of 8% of base salary.

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.

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.

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.

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.


• 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

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

Please note that joining our team does not create a guaranteed or permanent employment arrangement. 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.

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.