Job Summary

Performs System Test tasks for the development, commercialization, and life-cycle management of Transfusion and Cell Technology devices. This includes Verification and Validation activities such as impact analysis, test planning, test design, test execution, data analysis, and test reporting. May also include integration testing, debugging and root cause analysis.

Salary Range: $87,000 - $92,000
• 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: Onsite 3 days per week

Responsibilities

Demonstrate working knowledge of basic technical theories and principles. Assess feasibility of simple research and design concepts.

Works on problems of moderate scope where analysis of situations or data requires a review of a variety of factors.

Develop plans to verify and/or validate a system.

Develop test methods to explore design options and challenge requirements of apheresis devices and cell processing equipment.

Execute tests of apheresis devices and cell processing equipment at the system and subsystem level.

Record data with good documentation practices, including making observations.

Analyze data and interpret and document results.

Generate clear and detailed technical documentation, including plans, reports, execution, and results of tests or studies.

Manage traceability and versions of test objects: plans, requirements, test objectives, test scripts, test case records, and system issues.

Investigate issues to determine root cause using established problem-solving tools.

Set up and maintain test articles, test fixtures, and laboratory environment. Prepare blood for testing and characterize blood components after processing.

Participate in Risk Management activities.

Participate in Usability Engineering activities, such as formative and summative studies.

Interface effectively with product development teams and technical support groups.

Work under general supervision with latitude for independent judgment. May consult with senior peers on certain projects. Exercises judgment within defined procedures and practices to determine appropriate action.

Builds productive internal/external working relationships. Offer advice and assistance to team members regarding routine problems.

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.

This job position within the Business Unit - Transfusion and Cell Technologies (BU-TCT) of Fresenius Kabi USA hereby commits itself to protect any persons working under its control from work related hazards to health and safety as well as to protect the environment as the basis of life. This includes the prevention of diseases, incidents, and pollution as well as the responsible and sustainable use of resources. Our aim is to enhance our performance in the area of occupational and environmental safety, and to fulfill compliance obligations. To achieve this target, we implement and continuously improve the integrated management system according to ISO 14001 (Environmental Management System, or EMS) and ISO 45001 (Occupational Health and Safety Management Systems, or OHSMS).

Requirements
• B.S. or M.S. degree in Engineering (systems, biomedical, electrical, mechanical, or similar engineering discipline)

with 2+ years related experience.
• Basic skills with moderate level of proficiency. Must possess a firm foundation in the basic principles of their

respective engineering discipline.
• Previous experience with Medical Device Development preferred. Familiar with appropriate FDA QSR regulations,

design controls, document controls, and overall medical device industry knowledge.
• Experience with systems engineering tasks such as Requirement Management, Usability, Verification and Validation.
• Ability to diagnose and solve problems involving multiple technologies (i.e. mechanical, electrical, software).
• Ability to work with a cross-functional team, as well as independently.
• Task management skills with ability to prioritize multiple assignments.
• Orientation to details, natural inclination to be methodical and hands-on in a development lab environment.
• Familiarity with biological laboratory processes preferred.
• Proven capability in laboratory work, data analysis, system testing, and test design.
• Strong organizational, interpersonal, written, and verbal communication skills.
• Strong critical thinking skills and the ability to function in a sometimes-ambiguous situation.
• Ability to guide and direct the activities of a technician or co-op.

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.