Senior Reliability Engineer - Test Protocols & Compliance

Jobtailor; Warrendale (Allegheny County); On-site; USD 90,000 - 120,000; Full time

Job summary

Fresenius Kabi in Warrendale, PA, seeks a Reliability Engineer to plan and execute reliability tests for new products, maintain test equipment, and analyze field failure data. You will create test plans and protocols, ensure compliance with FDA guidelines, and collaborate with cross-functional teams.

The role requires 3+ years in reliability engineering on product development teams, with strong data analysis, problem-solving, and documentation skills.

Qualifications

• BS degree in Engineering or commensurate experience.
• Minimum 3 years of hands-on reliability engineering on product development teams.
• Experience with electromechanical assemblies and complex mechanisms.
• Proven data analysis, reliability testing, and test design skills.
• Experience creating Test Plans, Protocols, and Reports.
• Experience using PLM to manage documentation revisions per FDA requirements.
• 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 29 CFR 1910.1030 regulations.
• SQL experience is a plus.

Responsibilities

• Plan, design, execute, document, and analyze reliability tests for new products and 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

Skills

Reliability Testing

Data Analysis

Test Design

Test Plans

Test Protocols

Troubleshooting

Root Cause Analysis

Excel

Access

SQL

English Proficiency

Education

BS degree in Engineering

Tools

Jira

PLM

Reliability Test Equipment

Test Databases

Job description

Fresenius Kabi in Warrendale, PA, seeks a Reliability Engineer to plan and execute reliability tests for new products, maintain test equipment, and analyze field failure data. You will create test plans and protocols, ensure compliance with FDA guidelines, and collaborate with cross-functional teams.

The role requires 3+ years in reliability engineering on product development teams, with strong data analysis, problem-solving, and documentation skills.