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1+ months

Senior Biocompatibility Scientist

Medtronic
Rice, MN 56367
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Senior Biocompatibility Scientist

Location:

Rice Creek, Minnesota, United States

Requisition #:

2200022R

Post Date:

Feb 10, 2022


**Senior Biocompatibility Scientist**


**Careers that Change Lives**

Impact patient outcomes. Come for a job, stay for a career.


The individual in this position will develop and execute the biocompatibility analysis of medical device products, supporting the regulatory submission of both implantable and non-implantable Medtronic Neuromodulation products. This person will work closely with program/project cross-functional teams to develop biocompatibility strategy, assembling current design documentation, providing gap assessments and verification reports to remediate in accordance with international standards such as ISO10993 and European medical device regulations.


**Inclusion and Diversity:**

We believe that when people from different cultures, genders, and points of view come together, innovation is the result and everyone wins. Medtronic walks the walk, creating an inclusive culture where you can thrive.


**Day in the life:**

Develop biocompatibility strategies and prepare biological evaluation plan in consideration of gaps in materials, design and process to achieve optimal solutions that satisfy timeline, cost and technical requirements as they relate to biological safety

Coordinates and facilitates biocompatibility testing of materials and designs in accordance with FDA requirements, internal SOPs and standards

Liaise with internal resources (design, regulatory, quality, clinical and manufacturing) and external resources, developing and coordinating test strategies with Contract Research Organizations (CROs) to ensure appropriate planning and execution of required testing

Perform gap assessments of products by reviewing legacy documentation and evaluating device BOMs to determine the applicability of test data to ISO 10993 standard.

Write biological evaluation assessments to ensure all the relevant end points mentioned in ISO 10993 are met.

Analyze, interpret, and draw conclusions from biocompatibility testing, including, but not limited to, extractable and leachable chemical characterization and biological evaluations

Develop and deliver regulatory submission responses to biocompatibility related questions

Influence organization excellence by recommending approaches, procedures, and work aids as they relate to biocompatibility, in compliance with applicable global regulatory requirements

Participate in the analysis of technical issues and the development of recommendations for project decisions and actions


**Must Have: Minimum Qualifications**

- Bachelors degree

- 4+ years of experience with Bachelors Degree OR 2+ years of experience with an Advanced Degree


**Nice to Have**

Experience in the medical device industry

Knowledge of international and domestic regulations associated with biocompatibility

Experience applying industry standards such as ISO 10993 strongly preferred.

Knowledge of materials and interactions with the body and environment

Knowledge of Microsoft applications (Excel, Word, Outlook)

Demonstrated ability to deliver quality technical work within project schedules and timelines.

Must be team oriented, with the ability to work well on common deliverables with diverse cross-functional teams and to interact at the highest professional manner with all organizational levels

Excellent communication skills, both verbal and written, and interpersonal skills to successfully partner on varying levels ranging from cross functional to global multi-site and multi-business unit

Experience writing biological evaluations for new product and remediating existing products

Fundamental understanding of toxicological assessment, extractable and leachable analysis, medical device manufacturing processes, and biocompatibility assessment methodology

Biocompatibility testing knowledge of methods (analytical chemistry, in vitro and in vivo biology)

Technical understanding of the effect processing has on material properties and performance including on biocompatibility

Ability to correlate material properties with product performance and predict various failure modes


**About Medtronic**

Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life.


We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.

We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Lets work together to address universal healthcare needs and improve patients lives. Help us shape the future.


**Physical Job Requirements**

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.

The physical demands described within the Day in the Life 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.
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.

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Posted: 2022-03-15 Expires: 2022-06-13
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Senior Biocompatibility Scientist

Medtronic
Rice, MN 56367

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