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Sr. Chemist - Biocompatibility Specialist

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Research & Development
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19000EWE Requisition #
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Careers that Change Lives:


In this exciting role as a Sr. Chemist-Biocompatibility Specialist you will be responsible for creating biocompatibility plans, scientific documentation and timely evaluation of changes to existing products, material, and process changes for potential biocompatibility hazards within a Risk Management Framework in compliance with global medical device regulations. In addition, you will play a critical role with your quality engineering, research and development, operations, and regulatory partners in supporting key improvements to current products and processes.

 

This position is also responsible for generation of test plans, coordination of sample tests, and final reports suitable for regulatory submission as well as for the accuracy and integrity of documentation generated.


A Day in the Life

  

• Work as an extended team member of the Product Development Process (PDP) Team. Ensures all Biocompatibility related issues are addressed for the PDP. Leads project team in solving difficult problems.

• Analyzes products, raw materials, and in-process materials to ensure they are biocompatible and in alignment with regulatory standards and the company's quality program.

• Follows protocols and regulations to deliver safe and effective products, supplies, and processes.

• Interprets and evaluates the analyses in terms of accuracy and precision compared against established specifications and recommends and implements corrective action where necessary.

• Uses applicable standards, written procedures, statistical processes and academic understanding of biological principles to accomplish tasks.

• Applies existing techniques and procedures with recommendations and implementation of modification for improved efficiency, or devises and develops new analytical methods and techniques.

• Performs qualitative tests or quantitative assays on samples using techniques that vary from use of standard analytical equipment to highly modern and automated instrumentation.

• Evaluates and approves changes related to biocompatibility. May also be involved in establishing requirements for the transfer of methodology from R&D.

• Provide technical documentation concerning biological assessments of material and device safety as required for device qualification and marketing

• Development of Biological Risk Assessments and Test Plans for new products and material or process changes

• Exercises technical judgment in selecting and justifying appropriate biocompatibility test methods, techniques and criteria. Perform literature searches in support selection and justifications.

• Coordinate chemical characterization testing between internal clients and internal service providers

• Coordinate biological safety testing when required between internal clients and external service providers

• Update department technical procedures, work instructions, and other documentation as required

• Will participate in studies and other duties under general supervision as required.

• Conducts exploratory research to produce new knowledge and potential products; conceives, organizes, promotes, and executes ideas and plans to increase chemistry's role in and contribution to the discovery and chemical approaches to meet exploratory objectives in product discovery.

• Develops research proposals to provide a technically and economically sound basis for developing and evaluating new or improved products, synthetic methods, processes, and analytical and physical testing techniques.

• Recommends utilization of the results or changes in the scope of work or termination of projects.


Must Have: Minimum Requirements
To be considered for this role, please ensure the minimum requirements are evident on your resume.

Bachelor of Science Degree in Engineering, Chemistry, Biochemistry or Health Science Discipline with 4+ years of experience in a professional or academic research and/or

development setting or advanced degree in Engineering, Chemistry, Biochemistry or Health Science Discipline with 2+ years of experience in a professional or academic research and/or development setting,

Nice to Have

- Experience writing biocompatibility evaluations

- Knowledge of ISO 10993 series

- Degree in Chemistry or Life Sciences

- Knowledge of quality systems and regulatory submissions

- Auditing skills

- Experience with sample preparation/extraction/ separation techniques for material analyses

- Experience in healthcare industry supporting products that require pre-market approval (PMA)
- Write test requests for Chemical Characterization studies
- Cytotoxicity Testing
- Experience in polymer, analytical or synthetic chemistry
- Experience in instrumentation analysis
- Experience performing laboratory data interpretation including working with mathematical concepts relevant to the laboratory setting
- Experience with HPLC, GC, IC, spectroscopic techniques, ICP-AES, ICP-MS, GC/MS
- Experience reading, analyzing, and interpreting common scientific and technical journals, scientific procedures and regulatory guidelines.

- Experience drafting documentation in compliance with medical device regulations and processing through Documentation Change Control process

- Ability to coordinate work through outside service laboratories

- Ability to multitask and track multiple projects at various stages

- Work must show accuracy, attention to detail, completeness of documentation, and be well organized.


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. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.

Physical Job Requirements

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. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)

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