Sr Engineer (Medical Device Reliability)

Job Summary

The Senior Engineer, Reliability can 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 the reliability, safety, quality, and business goals. The Senior Engineer, Reliability, works under moderate supervision. Participates in designing, building, and maintaining of processes and documentation to test, report, and improve the reliability of medical device hardware and software.

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 consistent with a regulated environment.
• Works on problems of simple to moderate scope where analysis of situations or data requires a review of a variety of factors.
• Effectively operates as an individual contributor and a member of the large team.
• Exercises judgment within defined procedures and practices to determine appropriate action.
• Participates in technical reviews and responsible for organizing data and preparing appropriate documentation for assigned projects.
• Maintains reliability test equipment including the execution of regular maintenance activities.
• Accurate recording of 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 detailed troubleshooting documentation, for both internal and external customers.
• Assists in documentation, tracking, and analysis of field failure data.
• Develops and executes written test protocols designed to evaluate and demonstrate product reliability including but not limited to QALT (Quantitative Accelerated Life Testing) and Reliability Life Testing.
• Develops, fabricates, and qualifies reliability test fixtures.
• Designs in collaboration with the Hardware and Sustaining teams and develops processes, tools, or fixtures for testing products.
• Organizes test records to ensure that records are indexed, archived, and can be retrieved.
• Evaluates results relative to program goals.
• Applies standard techniques to solving difficult problems.
• Applies functional understanding of reliability theories and practices to daily activities.
• Displays full understanding and knowledge of regulations to apply guidance and standards on reliability activities and work products; prepare documentation for compliance with standard operating procedures.

Requirements

• BS degree in Engineering, or commensurate experience
• Minimum 3 year(s) of hands-on experience as a reliability engineer on product development teams
• 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
• Experience with SQL is a plus
• Experience with 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
• Experience with analyzing data to support reliability metrics
• Experience with diagnosing and solving problems involving multiple technologies (i.e. mechanical, electrical, software)
• Follow OSHA 29CFR 1910.1030 regulations

Benefits

Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision coverage.

Additional Information

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company contribution, and wellness program. 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.