Fresenius Kabi · 5 hours ago
Sr Engineer (Reliability)
Warrendale, PA
Full-time
Hybrid
Mid, Senior Level
$85K/yr - $95K/yr
3+ years expFresenius Kabi is seeking a Senior Engineer in Reliability to contribute to their Hardware Development Team and reliability programs. This role involves planning and executing reliability program activities to ensure the reliability, safety, and quality of medical device hardware and software.
BiotechnologyHealth CarePharmaceutical
No H1B
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
Design in collaboration to the Hardware and Sustaining teams and develop 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
Display 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
All employees are responsible for ensuring the compliance to company documents, programs and activities related to the Health, Safety, Environment, Energy, and Quality Management Systems, as per your roles and responsibilities
Qualification
Required
BS degree in Engineering, or commensurate experience
Minimum 3 year(s) 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
Ability to work as a collaborative team member
Analysis, troubleshooting, and debugging skills. 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
Ability to diagnose and solve problems involving multiple technologies (i.e. mechanical, electrical, software)
Follow OSHA 29CFR 1910.1030 regulations
Natural inclination to be methodical and hands-on in a development lab environment
Attention to details, natural inclination to be methodical and hands-on in a development lab environment
Strong problem solving and analytical skills
Benefits
401(k) plan with company contributions
Paid vacation
Holiday and personal days
Employee assistance program
Health benefits to include medical, prescription drug, dental and vision coverage
Life insurance
Disability
Wellness program
Company
Fresenius Kabi
Fresenius Kabi is a health care company, that offers therapy and care of chronically seriously ill people - in and out of hospitals.
10001+ employees
Funding
Current Stage
Late StageLeadership Team
Christian Mattis
Chief Financial Officer MedTech NAM
Tanja Greve
CFO BU Biopharmaceuticals
Recent News
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