Sr Engineer (Medical Device Reliability)

Job Summary The Senior Engineer, Reliability will play a key contributor role in our Hardware Development Team and reliability programs. This role plans and contributes to the reliability program activities to meet reliability, safety, quality, and business goals. Working under moderate supervision, the engineer participates in designing, building, and maintaining processes and documentation to test, report, and improve the reliability of medical device hardware and software. Salary Range: $85,000 - $95,000. Final pay determinations will depend on experience level, education, and skills. Hybrid role, 3 days per week in Warrendale, PA. Applicants must be authorized to work in the United States. Unsupported visa sponsorship. Responsibilities Plan, design, execute, document, and analyze a regimen of tests to predict the reliability of new products and product changes. Operate within defined processes and procedures consistent with a regulated environment. Work on problems of simple to moderate scope where analysis requires review of a variety of factors. Operate as an individual contributor and as a member of the larger team. Exercise judgment within defined procedures and practices to determine appropriate action. Participate in technical reviews and prepare appropriate documentation for assigned projects. Maintain reliability test equipment and execute regular maintenance activities. Accurately record test results and defects in Excel, Jira, or other test databases. Assist in root cause analysis of field returns and reliability test failures. Develop and maintain detailed troubleshooting documentation for internal and external customers. Assist in documentation, tracking, and analysis of field failure data. Develop and execute written test protocols designed to evaluate and demonstrate product reliability, including QALT and reliability life testing. Develop, fabricate, and qualify reliability test fixtures. Collaborate with Hardware and Sustaining teams to develop processes, tools, or fixtures for testing products. Organize test records to ensure indexed, archived, and retrievable records. Evaluate results relative to program goals and apply standard techniques to solve difficult problems. Apply functional understanding of reliability theories and practices to daily activities. Demonstrate full understanding of regulations, prepare documentation for compliance with standard operating procedures. Ensure compliance with company documents, programs, and activities related to 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 engineering documents including test plans, protocols, and reports. Experience using PLM to manage database and documentation revisions in accordance with FDA requirements. Collaborative team player. Analysis, troubleshooting, and debugging skills. SQL experience is a plus. Experience developing and running reliability test protocols. Task‑management skills with ability to prioritize multiple assignments with minimal supervision. Experience in data capture and manipulation in software tools such as Excel and Access; proficiency in analyzing data to support reliability metrics. Ability to diagnose and solve problems involving multiple technologies (mechanical, electrical, software). Follow OSHA 29 CFR 1910.1030 regulations. Methodical, hands‑on approach in a development lab environment. Attention to detail. Strong problem‑solving and analytical skills. Reasonable accommodations may be made for individuals with disabilities. Benefits 401(k) plan with company contributions. Paid vacation, holiday, and personal days. Employee assistance program. Health benefits including medical, prescription drug, dental, and vision coverage. Life insurance, disability, 401K with company contribution, and wellness program. Equal Opportunity / Affiliation Statement Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status. #J-18808-Ljbffr Fresenius Kabi USA