Hybrid role in Warrendale, PA with a focus on keeping on-market medical devices and supporting equipment performing reliably across their life cycle. You will contribute to design control documentation, electrical testing, and problem-solving that helps drive quality and safety for active and non-active hardware, software, and laboratory equipment.
Compensation: USD 100,000 - 120,000 per year. Experience level: 5+ years. This position is within a heavily regulated environment, so clear English communication and strong documentation practices are essential.
What You’ll Do
- Lead 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 creative problem-solving to address technical challenges and support quality across the product life cycle.
- Collaborate on the design, deployment, and continuous improvement of smart automation tools used in production of medical devices.
- Work with cross-functional teams to develop custom test fixtures and specialized hardware supporting product validation and manufacturing.
- Own 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 for electrical components.
- Analyze field return data, address customer complaints, and contribute to CAPA to support reliable, safe performance.
Key Qualifications
- Ability to speak, read, write, and understand English to perform essential functions, including independent understanding of policies, procedures, training materials, and workplace communications in a regulated work environment.
- Bachelor’s degree in Electrical Engineering and/or an Engineering degree with 5-7 years of relevant experience in automated test fixtures.
- Proficiency with automation and data analysis software, including Python, LabView, and Matlab.
- Experience troubleshooting hardware and software issues in a production environment.
- Ability to diagnose and resolve failures involving PCBs, connectors, cables, sensors, batteries, and power management circuits.
- Experience with electrical design tools such as Altium and Pspice, plus instrumentation like oscilloscopes and signal generators.
- Familiarity with relevant FDA QSR and ISO regulations, including IEC 60601, design controls, document controls, and design verification/validation.
- Strong foundation in the basic principles of the relevant engineering discipline.
- Ability to manage projects, coordinate contractors, and direct the activities of a technician.
- Excellent verbal and written communication skills.
Technologies
Python, LabView, Matlab, Altium, Pspice, oscilloscopes, signal generators
Benefits
- Medical, dental and vision coverage
- Life insurance
- Disability
- 401K with company contribution
- Wellness program
Work Location
Hybrid remote in Warrendale, PA 15086
Additional Information: 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. Joining the team does not create a guaranteed or permanent employment arrangement. Employment is at-will, and Fresenius Kabi is an Equal Opportunity/Affirmative Action employer.
