Senior Medical Device Reliability Engineer

Fresenius Kabi USA; Warrendale (Allegheny County); Hybrid; USD 85,000 - 95,000; Full time

Benefits offered by this job

Health benefits

401(k) with company contributions

Paid vacation and holidays

Job summary

Fresenius Kabi USA is seeking a Senior Engineer, Reliability to advance our Hardware Development and reliability programs. You will plan and execute testing to predict product reliability, design robust fixtures, and document findings in a regulated environment.

Role requires 3+ years in reliability or product testing, strong data analysis, and collaboration across hardware and sustaining teams. Hybrid Warrendale, PA with competitive salary and comprehensive benefits.

Qualifications

• BS degree in Engineering, or commensurate experience.
• Minimum 3 year(s) of hands-on experience as a reliability engineer or systems test 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 engineering documents including Test Plans, Protocols, and Reports.
• Experience using PLM to manage database and documentation revisions in accordance with FDA requirements.
• Weibull / reliability statistics preferred.
• Accelerated life testing (ALT/QALT) preferred.
• DFMEA and ISO 14971 risk management preferred.
• Medical device design controls and verification preferred.
• Reliability requirements and test strategy development preferred.
• Ability to work as a collaborative team member.

Responsibilities

• Plans, designs, executes, documents, and analyzes a regimen of tests to predict the reliability of new products and product changes.
• Operates within defined processes and procedures in a regulated environment.
• Works on problems of simple to moderate scope requiring analysis of multiple factors.
• Maintains reliability test equipment and performs regular maintenance.
• Records test results and defects in Excel, Jira, or other test databases.
• Assists in root cause analysis of field returns and reliability test failures.
• Develops and maintains troubleshooting documentation for internal and external customers.
• Develops, executes, and documents test protocols including ALT/QALT and RTL tests.
• Develops, fabricates, and qualifies reliability test fixtures.
• Designs in collaboration with Hardware and Sustaining teams testing processes and fixtures.
• Organizes test records for indexing and retrieval.
• Evaluates results against program goals and applies reliability theories.
• Ensures adherence to regulations and prepares compliance documentation.
• Supports Health, Safety, Environment, and Quality policies.

Skills

Data analysis

Reliability engineering

Technical writing

SQL knowledge

Education

BS in Engineering

Tools

Minitab

JMP

ReliaSoft Weibull++

MATLAB

Python

Excel

Windchill/PLM

Job description

Fresenius Kabi USA is seeking a Senior Engineer, Reliability to advance our Hardware Development and reliability programs. You will plan and execute testing to predict product reliability, design robust fixtures, and document findings in a regulated environment.

Role requires 3+ years in reliability or product testing, strong data analysis, and collaboration across hardware and sustaining teams. Hybrid Warrendale, PA with competitive salary and comprehensive benefits.