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Scientist V

Ft Worth, TX 76134

Posted: 09/20/2023 Employment Type: Contract Job Category: Scientific Job Number: 576445 Is job remote?: No Country: United States

Job Description

Seeking to hire a Principal Scientist to join our 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 the 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
  • Bachelors 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
  • Work hours: Standard M-F
  • Travel Requirements: Minimal
  • Relocation assistance: No
  • Sponsorship available: No

Preferred Requirements:
  • Advanced Degree and five years of directly related experience
Target pay: $60/hr
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