• Demonstrate the ability to apply technical theories and principles. Accurately assess results for validity and conformance to specifications.

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

• Develop system- and subsystem-level requirements for medical devices that include electromechanical hardware, software, disposables, and labeling.

• Participate in Risk Management and Usability Engineering activities.

• Develop moderately complex algorithms using pseudocode to define desired device behavior.

• Develop test plans and test methods to explore design options and challenge requirements.

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

• Record data with good documentation practices, including making observations.

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

• Analyze data and interpret and document results.

• Generate clear and detailed technical documentation.

• 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.

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, Risk Management, Usability, System Architecture, Verification and Validation.

• Ability to work with a cross-functional team, as well as independently.

• Familiarity with biological laboratory processes preferred.

• 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.

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability,401K with company match, andwellness 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.