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PURPOSE AND SCOPE:

The level Engineer II for Biocompatibility may be assigned to participate in a design project, execute the evaluation of prototypes, and accompany research and development activities to evaluate the biocompatibility and toxicological as well as EHS risks and contributing by that to Fresenius Medical Care products. As a member of the Quality & Regulatory team of the Vertical In-Center, the Engineer II may be assigned to break down high level tasks into smaller well-defined tasks. The Engineer II may be responsible to evaluate the design concept for biocompatibility, influence the pre-development project definition 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:

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 and international (e.g. EU MDR) 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 authority-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; advanced degree preferred.

EXPERIENCE AND REQUIRED SKILLS:

2 - 5 years' related experience.

Master's Degree with industry experience.

PhD Degree with Postdoctoral related experience.

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.