Principal Engineer

Fresenius Kabi USA•Warrendale, PA

1d•$100,000 - $120,000

About The Position

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.

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.

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.