Position Overview

Lead and support new ideas and technologies, sustainment, and optimization to develop and establish robust manufacturing processes for chemistry centered products and subassemblies. Job duties:
  • Work closely with R&D, Quality, and Regulatory in supporting the development of new products and manufacturing process to achieve a smooth and successful transfer to Manufacturing and Production Launch.
  • Collaborate with cross-functional departments and associates to achieve company objectives and resolve project issues.
  • Lead continuous improvement initiatives such as process improvements, optimization, and cost reductions for the chemical manufacturing lines.
  • Communicate project status and challenges in a timely, clear, and appropriate manner to the organization.
  • Direct research and the analysis of data to ensure robust and repeatable manufacturing processes.
  • Direct the execution of process and test method validations.
  • Manage required builds for new product development in a pilot or production setting, including training of Operators and coordination with production planning.
  • Review manufacturing documentation (MP, BR, BOM, etc.) for new product transfers to production and current production.
  • Confer with appropriate departments, resources, and/or outside services to prepare design modifications, clarify problems, and develop processes.
  • Direct and plan quality system documentation, specifications, and detailed drawings.
  • Manage nonconformances and/or CAPAs issued to the chemical manufacturing lines.
  • Lead and develop direct reports with varying technical experience from entry to senior level roles.
  • Perform additional duties as assigned.
    1. Bachelor’s Degree in Chemistry or related field of study.
    2. A minimum of six (6) years of relevant professional work experience in medical device or equivalent industry.
    3. Strong written and verbal communication skills.
    4. Proficient computer skills including MS Word, Excel, Outlook, Teams, Project, and statistical software.
    Desired Qualifications
    1. Eight (8) years of relevant professional experience in Medical Device or equivalent industry.
    2. A minimum of one (1) year of management or supervisory experience/responsibility.
    3. Knowledge of raw material and suppliers.
    4. Ability to read and prepare technical documentation.
    5. Knowledge of medical and technical development.
    6. Background in Lean/Six Sigma techniques.
    7. Proven history managing multiple projects and teams.