Fresenius Medical Care
Biocompatibility Engineer II
Fresenius Medical Care, Ogden, Utah, United States, 84403
Primary location is Ogden, Utah
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 teams, 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 the team to execute the project and solve the problems assigned by the CFT leader. The Engineer II requires intermediate supervision and may be tasked by the supervisor to mentor one or more entry level Engineer I employees.PRINCIPAL DUTIES AND RESPONSIBILITIES:
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 plans.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 the cross-functional product team.Oversees execution of testing at CROs to complete timely, quality sample testing.Develops and coordinates testing strategy with CROs.Participates or supports audits of external CROs and FDA, as required.Assists and prepares 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 toxicologists.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.EXPERIENCE AND REQUIRED SKILLS:
Bachelor's Degree in chemistry, bio-chemistry, analytical chemistry or scientific discipline required; advanced degree preferred.Minimum 2 or more years' related Biocompatibility experience.Experience working with cross-functional teams (Engineering, Manufacturing, Quality etc.).EO/AA Employer: Minorities/Females/Veterans/Disability/Sexual Orientation/Gender Identity
Fresenius Medical Care North America maintains a drug-free workplace in accordance with applicable federal and state laws.#J-18808-Ljbffr
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 teams, 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 the team to execute the project and solve the problems assigned by the CFT leader. The Engineer II requires intermediate supervision and may be tasked by the supervisor to mentor one or more entry level Engineer I employees.PRINCIPAL DUTIES AND RESPONSIBILITIES:
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 plans.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 the cross-functional product team.Oversees execution of testing at CROs to complete timely, quality sample testing.Develops and coordinates testing strategy with CROs.Participates or supports audits of external CROs and FDA, as required.Assists and prepares 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 toxicologists.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.EXPERIENCE AND REQUIRED SKILLS:
Bachelor's Degree in chemistry, bio-chemistry, analytical chemistry or scientific discipline required; advanced degree preferred.Minimum 2 or more years' related Biocompatibility experience.Experience working with cross-functional teams (Engineering, Manufacturing, Quality etc.).EO/AA Employer: Minorities/Females/Veterans/Disability/Sexual Orientation/Gender Identity
Fresenius Medical Care North America maintains a drug-free workplace in accordance with applicable federal and state laws.#J-18808-Ljbffr