Engineering Specialist (Reliability)

Fresenius Kabi USA • Warrendale, PA

19h • Hybrid

About The Position

The Engineering Specialist, Reliability serves as the technical lead and Subject Matter Expert for the reliability programs of BU-INS-IVX infusion systems, encompassing both software and hardware. This role is responsible for planning and leading reliability program activities to ensure the achievement of reliability, safety, quality, and business objectives. The position is eligible to participate in a bonus plan with a target of 15% of the base salary. Final pay determinations will depend on various factors, including experience level, education, knowledge, skills, and abilities. The company offers comprehensive benefits and programs designed to support colleagues' health and well-being. This is a hybrid role requiring onsite presence 3 days per week. Applicants must be authorized to work for ANY employer in the United States, as Fresenius Kabi is unable to sponsor or take over sponsorship of an employment visa.

Requirements

• BS degree in Engineering, or commensurate experience
• 10+ years of hands-on experience as a reliability engineer on product development teams
• 3+ years of direct experience working on medical devices in an FDA regulated environment
• Experience with electromechanical assemblies and complex mechanisms
• Experience with developing and running reliability test protocols
• Proficiency in analyzing data to support reliability metrics
• Follow OSHA 29CFR 1910.1030 regulations
• 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

• Lead and promote a reliability-driven culture within the R&D team.
• Using specialized knowledge and benchmarking skills, define and implement effective reliability strategies for new products and product changes to meet reliability targets.
• Display advanced understanding of theories/practices utilized by own discipline and other disciplines outside the primary area of expertise to identify improvements in product reliability assessment and performance.
• Devise new approaches to complex problems through adaptations and modifications of standard technical principles.
• Establish and document sound planning, testing and analysis activities.
• Network with senior internal and external personnel in own area of expertise to effectively operate and facilitate cross-functional teams.
• Routinely provide advice and assistance to team members regarding routine and unique problems.
• May mentor or direct Sr engineers and lower-level engineers on assigned projects.
• Define reliability metrics for new and existing products.
• Evaluate and drive reliability growth.
• Analyze and interpret test data and field complaints and perform reliability assessment and predictions.
• Conduct reviews with key stakeholders to identify trends and opportunities for improvements.
• Develop appropriate QALT, HALT, HASS and ALT tests on components and assemblies.
• Identify and purchase equipment or fixtures needed for effective reliability testing.
• Collaborate with engineers in cost reduction design projects, optimizing designs for reliability and uptime.
• Lead investigations and diagnostic testing of returned products to inform problem solving strategies.
• Participate in product design reviews and change impact meetings.
• Participate in hazard and failure mode assessments (dFMEA, FTA, etc.).
• Mentor junior team members to grow team competencies and promote career development.
• Manage Reliability engineers to guide the team, grow competencies and promote career development.
• Work with extensive latitude for independent judgment to resolve issues and contribute to the team’s development.
• 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.
• Ensure compliance with company documents, programs and activities related to the Health, Safety, Environment, Energy, and Quality Management Systems, as per your roles and responsibilities.

Benefits

• bonus plan with a target of 15% of the base salary
• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Number of Employees: 501-1,000 employees