Fresenius Medical Care North America Engineer II, Biocompatibility in Ogden, Utah
Job ID 19000CNW
Available Openings 1
PURPOSE AND SCOPE:
The level Engineer II may be assigned to participate in a design project, execute the building of prototypes, and pioneer research and development activities contributing to Fresenius products. As a member of one or more Fresenius R&D team, the Engineer II may be assigned to break down high level tasks into smaller well-defined tasks. The Engineer II may be responsible to initiate the design concept, formulate the pre-development project and participate actively in the feasibility study as assigned. The Engineer II can be part of cross-functional teams (CFT) as assigned by the supervisor. If so, this person will work closely with team to execute the project and solve the problems assigned by the CFT leader. The Engineer II requires intermediate supervision. The Engineer II may be tasked by the supervisor to mentor one or more entry level Engineer I employees.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
Be involved in various projects as assigned by direct supervisor.
Authors testing plans, engineering test reports and position and/or white papers.
Builds productive working relationships.
Learns FDA/ISO Design Control regulations and their application.
Offers ideas and potential inventions to be used in new products.
Continuously improves knowledge related to research projects by continuous assessment of current publications.
Hands-on involvement with fabrication, processing, and develops detailed engineering specifications under intermediate supervision.
Develops new techniques, test protocols, writes SOP / TM and perform validations on TMs as assigned.
Coordinates secondary projects and supports sub tasks of other projects as assigned. Completes these tasks with intermediate supervision.
Maintains general housekeeping of working area and plant.
May provide assistance to Engineer I staff with general tasks that require a better understanding of functions, as directed by immediate supervisor.
Seeks senior level staff or supervisory assistance with higher level problems that may arise.
Normally receives general work instructions on routine work, detailed instructions on new projects or assignments. Is assisted with these tasks by senior level or supervisory assistance as required. Works with intermediate independence. Work is reviewed for soundness.
May participate in cross-functional teams on new product development and manufacturing problem-solving efforts as assigned.
Assists GMQ sites with set-ups, adjustment and operation training on production equipment and evaluates analysis instruments.
Review and comply with the Code of Business Conduct and all applicable company policies and procedures, local, state and federal laws and regulations.
Writes engineering reports, feasibility reports as assigned.
Maintain assigned documentation and design history files per establish standards.
Exercises best judgment within defined procedures and practices to accomplish assigned tasks.
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.
- Bachelor’s Degree in related Engineering or scientific discipline required; advanced degree preferred.
EXPERIENCE AND REQUIRED SKILLS:
2 – 5 years’ related experience.
Master’s Degree with industry experience.
PhD Degree with Postdoctoral related experience.
Possess expertise in ISO/AAMI 10993, FDA Guidance, ASTM, and biocompatibility specific standards, as well as knowledge of current industry trends and upcoming standards application
Coordinates biocompatibility testing of materials and products in accordance with FDA requirements
Partners with biocompatibility colleagues and stakeholders to prepare and execute biocompatibility test plan
Coordinates biocompatibility projects and collaborates with cross-functional teams for product development efforts on new or existing products in accordance with FMCNA biocompatibility SOP
Supports design control process activities within cross-functional product team
Oversees execution of testing at CRO’s to complete timely, quality sample testing.
Develops and coordinates testing strategy with CRO’s.
Participate or support audits of external CRO’s, as required.
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
EO/AA Employer: Minorities/Females/Veterans/Disability/Sexual Orientation/Gender Identity
Fresenius Medical Care North America
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