Senior Engineer – Medical Device Reliability

Fresenius Kabi USA

Senior reliability engineer testing medical-device hardware and software for Fresenius Kabi, a global healthcare company. Designing reliability protocols, analyzing failures, and developing test fixtures in Warrendale.

Posted 8/10/2026full-timeWarrendale • Pennsylvania • 🇺🇸 United StatesSenior💰 $85,000 - $95,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in reliability testing, data analysis, and compliance within regulated environments. Proficient in developing test protocols and collaborating with cross-functional teams to enhance product reliability.

Highest-signal resume keywords

Reliability TestingData AnalysisTest Protocol DevelopmentElectromechanical AssembliesCompliance with FDA Regulations

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Reliability TestingData AnalysisTest DesignTest PlansTest ProtocolsTroubleshootingSQLExcelAccessRoot Cause Analysis

Soft Skills

Problem-SolvingAnalytical SkillsTask ManagementCollaborationCommunication

Tools & Technologies

JiraPLMReliability Test EquipmentTest Databases

Industry Keywords

Health and SafetyQuality Management SystemsOSHA RegulationsReliability Life TestingField Failure Data

Tech Stack

Tools & technologies

SQL

About the role

Key responsibilities & impact

Plan, design, execute, document, and analyze reliability tests for new products and product changes
Operate within defined processes and procedures in a regulated environment
Participate in technical reviews and organize data and documentation for assigned projects
Maintain reliability test equipment and perform regular maintenance
Record test results and defects in Excel, Jira, or other test databases
Assist with root cause analysis of field returns and reliability test failures
Develop and maintain troubleshooting documentation for internal and external customers
Document, track, and analyze field failure data
Develop and execute written test protocols, including QALT and Reliability Life Testing
Develop, fabricate, and qualify reliability test fixtures
Collaborate with Hardware and Sustaining teams to develop testing processes, tools, and fixtures
Organize, index, archive, and retrieve test records
Evaluate results against program goals
Apply reliability theories, practices, regulations, guidance, and standards to reliability activities and compliance documentation
Ensure compliance with Health, Safety, Environment, Energy, and Quality Management Systems

Requirements

What you’ll need

BS degree in Engineering, or commensurate experience
Minimum 3 years of hands-on experience as a reliability engineer on product development teams
Experience with electromechanical assemblies and complex mechanisms
Proven capability in data analysis, reliability testing, and test design
Ability to create Test Plans, Protocols, and Reports
Experience using PLM to manage database and documentation revisions in accordance with FDA requirements
Experience developing and running reliability test protocols
Experience in data capture and manipulation using Excel and Access
Proficiency in analyzing data to support reliability metrics
Ability to diagnose and solve problems involving mechanical, electrical, and software technologies
Follow OSHA 29CFR 1910.1030 regulations
Analysis, troubleshooting, and debugging skills
SQL experience is a plus
Task management skills and ability to prioritize multiple assignments with minimal supervision
Ability to work collaboratively as a team member
Strong problem-solving and analytical skills
Methodical, hands-on approach in a development lab environment
Ability to effectively speak, read, write, and understand English
Applicants must be authorized to work for any employer in the United States; Fresenius Kabi cannot sponsor or take over sponsorship of an employment visa

Benefits

Comp & perks

401(k) plan with company contributions
Paid vacation, holiday and personal days
Employee assistance program
Medical, prescription drug, dental and vision coverage
Life insurance
Disability coverage
Wellness program