Senior Engineer – Medical Device Reliability

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

• 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

• 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

Core Competencies

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 Testing
• Data Analysis
• Test Protocol Development
• Electromechanical Assemblies
• Compliance with FDA Regulations

ATS Optimization Keywords

Hard Skills

• Reliability Testing
• Data Analysis
• Test Design
• Test Plans
• Test Protocols
• Troubleshooting
• SQL
• Excel
• Access
• Root Cause Analysis

Soft Skills

• Problem-solving
• Analytical Skills
• Task Management
• Collaboration
• Communication

Industry Keywords

• Health and Safety
• Quality Management Systems
• OSHA Regulations
• Reliability Life Testing
• Field Failure Data

Tools & Technologies

• Jira
• PLM
• Reliability Test Equipment
• Test Databases