Bio/ Toxicologist Ii

**Careers that Change Lives
**A Day in the Life
**POSITION RESPONSIBILITIES:
- Performs within the requirements of the Medtronic site Quality System.
- Provide biological safety assessment to achieve ISO 10993 compliance and to support product development activities.
- Provide guidance in the development of product and selection of materials to ensure that released designs meet biological safety requirements. The Toxocologist is responsible for the timely completion of technical deliverables.
- Prepares documentation of biological assessment efforts using sound scientific principles. Coordinates biological testing activities by partnering with MDT Physiological Research Laboratories, NAmSA, Apptec, or Toxicon as appropriate. Provides primary interface with MDT Physiological Research Laboratories for MDT XMD.
- Establishes and integrates risk management process as part of the biological evaluation program in a manner that complies with ISO 10993.
- Assesses the biological safety impact from manufacturing and supplier changes on patient-contacting devices.
- Consults on the biological safety impact from device field issues.
- Develops or identifies resources and provides training to aid product development activities with biological evaluation process. (Web-based biomaterials support, biomaterials testing databases)
- Mentors engineers.
- All activities must be performed in compliance with the Quality System.
- Performs duties in compliance with environmental, health and safety related site rules, policies or governmental regulations.
- All other duties as assigned.
- Travel requirement: Less than 10%

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**BASIC QUALIFICATIONS:
**EDUCATION REQUIRED**:

- Bachelor’s degree

**YEARS OF EXPERIENCE**
- Bachelor’s degree with 2+ years of experience.
- Masters Degree with 0 years of experience in toxicology, physiology, or related discipline.

**SPECIALIZED KNOWLEDGE REQUIRED**
- No specialized knowledge required.

**PREFERRED QUALIFICATIONS**
- Master's degree preferred.
- In-depth knowledge of biological impact of foreign materials in the human body.
- Knowledge of applicable ASTM, ISO, FDA and EN standards. An in-depth understanding of ISO 10993 - Biocompatibility standard.
- Requires strong problem solving and analytical skills.
- Computer proficiency using word processors, spreadsheet, project management, and statistical software programs is required.
- Strong oral and written communication skills
- Excellent presentation skills.
- Must be able to handle multiple tasks/projects and manage priorities accordingly.
- Must be able to work in a team environment, including cross-functional teams, and exert influence without alienating others.
- Unimpeachable integrity.
- A sense of humor.

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**PHYSICAL JOB REQUIREMENTS**:Physical capabilities to perform the job
- The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to use a computer, and communicate with peers and co-workers.
- The employee must be able to lift 10 pounds per job requirement.

**WORK ENVIRONMENT**:The 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.
- While performing the duties of this job, the employee is occasionally exposed to humid conditions because of air conditioning units used to control the building environment. The noise level in the work environment is usually quiet.

The above description is intended to describe the general content, identify the essential functions of, and requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities or requirements