Senior Medical Device Reliability Engineer (Hybrid)

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

Benefits offered by this job

401(k) with company contributions

Paid vacation and holidays

Personal days

Health benefits: medical, Rx, dental,視

Wellness program

Job summary

Fresenius Kabi USA seeks a Senior Engineer, Reliability to contribute to our Hardware Development Team and reliability programs. You will plan, design, execute and document tests to predict the reliability of medical device hardware and software, while adhering to regulatory requirements.

The role is hybrid in Warrendale, PA with three days on-site. A BS in Engineering and 3+ years in reliability or systems testing on product teams are required; strong data analysis, documentation, and

Qualifications

• BS degree in Engineering or commensurate experience.
• Minimum 3 years hands-on experience as a reliability 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 per FDA requirements.
• Weibull/reliability statistics preferred.
• Accelerated life testing (ALT/QALT) preferred.
• Medical device design controls and verification preferred.

Responsibilities

• Plans, designs, executes, documents, and analyzes tests to predict reliability of new products.
• Operates within regulated processes and procedures in a development team.
• Acts as an individual contributor within a large team.
• Organizes data and prepares documentation for projects.
• Maintains reliability test equipment and conducts maintenance.
• Records test results and defects in Excel, Jira, or test databases.
• Assists in root cause analysis of field returns and failures.
• Develops and maintains troubleshooting docs for internal and external customers.
• Develops and executes written test protocols (QALT, RLT).
• Designs, fabricates, and qualifies reliability test fixtures.
• Collaborates with Hardware and Sustaining teams to develop testing tools.
• Organizes test records for indexing, archiving, and retrieval.
• Evaluates results against program goals; applies reliability theories.
• Ensures compliance with SOPs and regulatory guidance.

Skills

Reliability engineering

Data analysis

Test design

Root cause analysis

Technical writing

Problem solving

Collaboration

Education

Bachelor's degree in Engineering

Tools

PLM/Windchill

Minitab

JMP

ReliaSoft Weibull++

MATLAB

Python

Excel

SQL

Access

Job description

Fresenius Kabi USA seeks a Senior Engineer, Reliability to contribute to our Hardware Development Team and reliability programs. You will plan, design, execute and document tests to predict the reliability of medical device hardware and software, while adhering to regulatory requirements.

The role is hybrid in Warrendale, PA with three days on-site. A BS in Engineering and 3+ years in reliability or systems testing on product teams are required; strong data analysis, documentation, and