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:
Understand the basic principle of biocompatibility testing concept
Familiar with the external standards to perform the biocompatibility testing.
Familiar with Design Control concept apply it to the biocompatibility testing.
Familiar with Fresenius’ biocompatibility testing SOP
Follows SOP to perform the biocompatibility testing for assigned project
Collaborates with cross-functional teams to participate team activities and response on the biocompatibility testing for a specific project.
Oversees execution of testing at CRO’s to complete timely, quality sample testing.
Develops and coordinates testing strategy with CRO’s.
Assists in maintaining biocompatibility project documentation according to quality procedures.
Works with regulatory affairs department on preparing information related to FDA-related correspondences.
Prepares technical presentations relevant to the biocompatibility program/projects
Coordinates toxicological risk assessments with toxicologist
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.
EDUCATION:
Bachelor's Degree in related Engineering or scientific discipline required
EXPERIENCE AND REQUIRED SKILLS:
0 - 2 years' related experience.
Excellent oral and written communication skills
EO/AA Employer: Minorities/Females/Veterans/Disability/Sexual Orientation/Gender IdentityFresenius Medical Care North America maintains a drug-free workplace in accordance with applicable federal and state laws.