Senior Engineer, Reliability

Fresenius Kabi USA•Warrendale, PA

4d•$130,000 - $140,000•Hybrid

About The Position

The Senior Engineer, Reliability is a self-starter who 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.

Requirements

BS degree in Engineering, or commensurate experience
8 years minimum of hands-on experience as a reliability engineer on product development teams
Minimum of 3 years of experience developing within a regulated environment (Medical, Aerospace, Military)
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
Experience using PLM to manage database and documentation revisions in accordance with FDA requirements
Attention to details, natural inclination to be methodical and hands-on in a R&D lab environment.
Task management skills with ability to prioritize multiple assignments.
Strong problem solving and analytical skills.

Responsibilities

Lead and promote a reliability-driven culture within the R&D team.
Define and implement effective reliability strategies for new products and product changes to meet reliability targets.
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 supervise 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.
Performs and contribute to DFMEA according to product / system functional analysis, and updates reliability tests accordingly.
Identify risks and resolve issues that may negatively impact project schedules and identify solutions to improve project schedules.
Investigate new technologies and best practices.
Establishes and performs DoE to assess and characterize new solutions and designs.
Design in collaboration to the Hardware and Sustaining teams and develop processes, tools or fixtures for testing products.
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 product to inform problem solving strategies.
Participate in product design reviews and change impact meetings.
Mentor junior team members to grow team 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.
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