Position Overview

Leads the projects associated with developing and optimizing polymer/chemical processes to manufacture new medical devices, combination devices and/or line extensions. Provides hands on support to characterize processes and implements innovative fixtures and automation to build optimum processes. Develops small scale process transitioning into large scale processes. Spearheads the root cause analysis investigations, related to product and process inconsistencies. Works closely with Manufacturing, Quality and Regulatory teams internally and outside vendors. Job duties
  • Initiates process conceptualization and development on bench scale.
  • Spearheads scale up activity through pilot and manufacturing in conjunction with Manufacturing Engineering.
  • Implements fixtures, equipment and automation to create optimum manufacturing processes and product testing.
  • Formulates hypothesis, designs experiments (DOE), collects and analyzes data and presents solutions to R&D and manufacturing teams.
  • Supports validation and verification of product, equipment and processes.
  • Spearheads the root cause analysis investigations related to product and process failures.
  • Supports builds for new products in prototype, pilot and production setting, including training of Operators, Technicians, and Manufacturing Engineers.
  • Spearheads cost reduction steps to improve existing processes.
  • Documents process and product investigations.
  • Executes process development and issue resolution with minimum supervision.
  • Performs additional responsibilities as assigned.

    1. Bachelor’s Degree in Chemical engineering and/or Material Science Engineering or Chemistry.
    2. A minimum of six (6) years of hands on process, chemical process manufacturing engineering experience in medical device industry.
    3. Knowledge of hydrogel, polymer or chemical processes is required.
    4. Experience in development of pilot processes is required.
    5. Strong technical and hands on skills including validation experience in scale up is required.
    6. Proven ability to design, execute and analyze processes using designs/experiments.
    Desired Qualifications
    1. Experience working on products from bench scale to manufacturing and troubleshooting.
    2. Exposure to drug manufacturing a plus.
    3. Ability to read and prepare technical documentation, including manufacturing and R&D procedures, specs and engineering drawings.
    4. Ability to prioritize and meet deadlines in a timely manner.
    5. Expert proficiency with MS Word, Excel, PowerPoint, SolidWorks and/or other CAD systems.