Principal Scientist

Exciting development opportunity to work for a global leader dedicated to helping people see brilliantly. The largest device company in the world – with complementary businesses in Surgical and Vision Care.

Our client is looking to hire a Principal Scientist to join the R&D Team in Fort Worth, TX.  You will be responsible for toxicological and biocompatibility evaluations of products and technologies required for product approvals and patient safety across our clients Technology Platforms.

•              Partner with toxicology leaders to develop robust biocompatibility and nonclinical testing strategies to meet project goals and ensure patient safety of products.
•              Conduct safety assessment for new product development and provide solutions for evaluation of safety risk for manufacturing and product life cycle assessments.
•              Work functional leaders across the organization to execute product design evaluations required for product approvals
•              Drive interactions with project teams early in the process to identify potential toxicological/safety risks to projects and develop robust Biological Evaluation Plans to mitigate the risks.
•              Interface closely with the manufacturing site to ensure business needs are met for life cycle management and materials teams for product stewardship toxicology assessments.
•              Competent in literature searches, extracting relevant information, critical study selection to aid in developing the risk assessment.
•              Familiar or experience in conducting risk assessments according to ISO 10993-17.
•              Experience with in-silico and QSAR models for use in toxicological risk assessments (e.g., Derek/Nexus, Tox Tree, OECD QSAR Tool Box, etc.).
•              Familiar or experience with ISO 14971, ISO 13485, ISO 10993-1 standards.
•              Experience developing and executing nonclinical toxicology studies under Title 21 CFR; Part 58 Good Laboratory Practice (GLP) Regulations.
•              Familiar or experience with medical device submissions (e.g., PMA, IDE, MDR, etc.) to regulatory authorities. 

Key Requirements/Minimum Requirements
•              Bachelor’s Degree or equivalent years of directly related experience (or high school +13 yrs; Assoc.+9 yrs; M.S.+2 yrs; PhD+0 yrs)
•              The ability to fluently read, write, understand and communicate in English
•              5 Years of Relevant Experience

This job description is a complete list of all desired skills but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!

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