Job Summary

The Engineering Specialist, Reliability is the technical lead and Reliability Subject Matter Expert of the BU-INS-IVX infusion systems (Software and Hardware) reliability programs. This role plans and leads the reliability program activities to meet the reliability, safety, quality, and business goals.

Salary Range: $145,000 - $155,000

• Position is eligible to participate in a bonus plan with a target of 15% of the base salary (include only if applicable to the grade level)
• 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: Onsite 3 days per week

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. Erroneous decisions or failure to achieve solutions may result in additional costs or serious delays in overall schedules.
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.
All employees are responsible for ensuring compliance with 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
•     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
 

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.