Job Summary
The Sr Engineer performs System Engineering tasks for the development, commercialization, and life-cycle management of Transfusion and Cell Technology devices. This includes Requirement Management, Risk Management, Usability Engineering, Algorithm Development, Test Planning, Integration Testing, Debugging and Root Cause Analysis.
Implements cost reductions and product enhancements while working in a team environment with cross functional team members, such as manufacturing sites, marketing, quality, regulatory and other departments.
Responsibilities
- 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.
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 match, 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.
