PURPOSE AND SCOPE:
The entry level Engineer will participate in designing, executing, and championing research and development activities of Fresenius' products. As a member of a tech team, the Engineer I environment is mentored - with oversight from higher level Engineers to complete pre-defined work. The Engineer I may be involved in quality planning, internal audits, data collection and analysis, specification development and review and design review and qualification. The Engineer I will work with cross-functional teams to develop, commercialize, and maintain high quality.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
Works as a team member to design, develop, edit, and modify test plans, protocols, and reports for multiple projects by analyzing component, software and system requirements and following the appropriate developmental and design control process.
Participates in verification plans and protocol reviews and other related design reviews.
Works with product development teams to evaluate system interfaces, operational requirements, and performance requirements, and testability software.
Creates, identifies, validates, and uses test methods that facilitate data gathering and test method execution.
Participates in the design, build, validation and deployment of effective test automation solutions.
Understands defect management and works closely with Engineers on defect resolution.
Maintains effective communication with team members on project scope, timelines, and design changes.
Works on complex issues where analysis of a situation or data requires an in-depth evaluation of variable factors. Exercises judgment in selecting methods, techniques and evaluation criteria for obtaining results.
Determines methods and procedures on new assignments and may coordinate activities of other personnel (Team Lead).
Other duties as assigned, not limited to:
Responsible for lab layout and expansion
Conduct and track defect investigations
Build test bench and test fixtures
Handle material purchasing and lab inventory management
Hands-on prototype assembly, testing, data analysis
Trouble shooting electronic circuitry, hydraulic and/or pneumatic systems
Other duties as assigned.
Additional responsibilities may include focus on one or more departments or locations. See applicable addendum for department or location specific functions.
PHYSICAL DEMANDS AND WORKING CONDITIONS:
The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Regularly required to talk, hear, sit, stand, and walk.
Must be able to lift 50 lbs. with assistance as required.
Bachelor's Degree in related Engineering or scientific discipline required
EXPERIENCE AND REQUIRED SKILLS:
Bachelors degree and minimum one or more years' related experience.
Demonstrated understanding of principles, theories and concepts in the engineering field, Mechanical, Electrical, Biomedical engineering, or related fields preferred.
Experience with Python, C, and C++ scripting for data acquisition and processing, is preferred.
Experience using tools to test and troubleshoot software applications.
Excellent organizational and verbal/written communication skills.
Strong interpersonal skills with ability to work effectively in a team or individually with supervision.
Highly motivated and energetic. Passion for creating high quality medical devices.
Experience and familiarity with ISO 13485 and IEC 62304, and with FDA GMP, is preferred.
Experience with sensors, microprocessor/microcontroller and/or FPGA based digital design, is preferred.
Excellent oral and written communication skills
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