Position Overview

Support the development and manufacture of medical devices. Work with Manufacturing, R&D, and/or R&D Chemist to resolve product quality issues. Support manufacturing process changes, product design changes/improvements, and the implementation of new products. Job duties:
  • Work with R&D Chemists to support analytical test method validation by reviewing test protocols and reports.
  • Work with R&D Engineers, R&D Chemists, and Manufacturing to support design transfer of analytical test processes from R&D to Production.
  • Work with R&D Engineers to support implementation of new products by reviewing quality and testing plans.
  • Work with cross-functional team to create risk documents (i.e., Hazard Analysis, Risk Analysis, Design and Process FMEA), with special focus on chemical processes.
  • Perform additional duties and responsibilities as assigned.

    1. Bachelor’s degree in Chemistry, Chemical Sciences, or a related field.
    2. Minimum of three (3) years of related experience.
    3. Strong written and verbal communication skills.
    4. Must be able to perform and interpret GC and HPLC testing.
    5. Proficient with MS Word, Excel, Teams, and Outlook.
    Desired Qualifications
    1. Knowledge of medical product manufacturing.
    2. Knowledge of medical product quality assurance (including the requirements test protocols, test reports and statistical techniques).
    3. Knowledge of medical product design control process.
    4. Knowledge of 21CFR820, ISO9001/13485.