Medtronic is seeking to solve challenges related to biocompatibility assessments and regulatory submissions for their medical devices, requiring expertise in chemical characterization and data analysis to ensure product safety and compliance.
Requirements
- BS in science, medical technology, or related fields. MS or PhD preferred
- Strong skills in design of experiments, data analysis, written and verbal communications, and collaboration
- Critical thinking skills to Interpret available data and recommend strategies to resolve technical challenges
- Applies comprehensive knowledge and a thorough understanding of concepts, principles, and technical capabilities to perform varied tasks and projects
- Author, execute, review, and approve protocols, reports, and/or regulatory submissions pertaining to chemical characterization per ISO 10993-12, 17 and 18.
- Provide objective assessment through critical review, interpretation and analysis of raw data, clinical relevance, toxicological risk assessments and trending
- Root cause(s) and efficient recommendations for resolution
Responsibilities
- Perform chemical characterization in alignment with biocompatibility assessments, organizing and coordinating required testing, and preparing clear, concise, and well-structured test plans and reports to support regulatory submissions.
- Provide technical documentation supporting biological assessments of material and device safety in accordance with ISO 10993-1 by conducting chemical characterization analysis impact assessments for changes in materials, processes, or intended uses of devices.
- Coordinate and oversee chemical characterization testing with external laboratories, and analyze test results to ensure regulatory compliance.
- Perform technical feasibility and design verification activities in a product development environment, including chemical characterization analysis, toxicological risk assessments, materials of concern (MOC) in collaboration with department staff and contract laboratories.
- Interpret chemical characterization data to integrate into the Biological Evaluation Report (BER), preparing devices for submission to internal and external laboratories, maintaining good documentation practices, and ensuring accurate records of original information.
- Author, execute, review, and approve protocols, reports, and/or regulatory submissions pertaining to chemical characterization per ISO 10993-12, 17 and 18.
- Provide objective assessment through critical review, interpretation and analysis of raw data, clinical relevance, toxicological risk assessments and trending
Other
- Requires a Bachelors degree and minimum of 2 years of relevant experience, or advanced degree with 0 years of experience.
- Must be self-motivated and able to multi-task, meet tight deadlines and prioritize changing demands in a fast-paced environment
- Close collaboration with multidisciplinary and cross-functional teams
- Contribute to scientific presentations and author relevant technical publications as needed.
- The role supports product development by designing and executing design verification test methods
