Job Summary

Salary Range: $85,000 to $95,000 Per Year

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.

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.

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.
   

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.

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.