Sr Engineer (Medical Device Reliability)

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

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, work 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.

Salary Range: $85,000 - $95,000

Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities.

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.

Hybrid role, 3 days per week in Warrendale, PA

Applicants must be authorized to work for ANY employer in the United States. Fresenius Kabi is unable to sponsor or take over sponsorship of an employment visa either now or in the future.

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

Requirements

The requirements listed below are representative of the knowledge, skill, and /or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• 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 preferredMedical device design controls and verification preferred
• Reliability requirements and test strategy development preferred
• 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
• Attention to details, natural inclination to be methodical and hands-on in a development lab environment.
• Preferred Technical Tools: Minitab, JMP, ReliaSoft Weibull++, MATLAB or Python for data analysis, Excel (advanced statistical functions), Windchill/PLM systems, Requirements management tools
• Ability to work across Systems, Quality, Regulatory, and R&D teams preferred
• Strong technical writing and presentation skills preferred
• Ability to justify reliability strategies to management and regulators preferred
• Mentoring junior engineers and technicians preferred
• Project planning and execution preferred
• The Company's primary business language is English. The successful candidate must be able to effectively speak, read, write, and understand English to perform the essential functions of the position, including independently understanding policies, procedures, training materials, and workplace communications written in English due to our heavily regulated work environment.

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.

Please note that joining our team does not create a guaranteed or permanent employment arrangement. All employment is at-will, meaning both the employee and Fresenius Kabi have the right to end the employment relationship at any time, in accordance with applicable federal and state laws.

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.