***Ideal candidate has Chemical Engineering and/or Chemistry background + medical device process engineering experience. Any type of disposable device manufacturing is preferred.

Principal Duties & Responsibilities
* Lead process improvement projects. Perform project management, planning, scheduling, and resource allocation.
* Provide hands-on problem solving support to manufacturing. Analyze test results and process yields to identify and prioritize improvement opportunities.
* Design experiments, analyze internal and customer data to identify and solve problems.
* Write validation plans, experimental plans and reports, equipment specifications, etc.
* Write change orders to improve quality, costs, documentation, and/or regulatory compliance.
* Research technologies and techniques for applicability to current and future products.
* Must be independent top-level technical resource as well as team player.

Education & Experience:
Requires a B.S. in Chemical or Biomedical Engineering or Chemistry, MS preferred.
* Five years experience in the manufacture and/or development of complex processes or products.
* Must possess broad technical knowledge in engineering and chemistry as well as other applicable technologies.
* Direct experience working in FDA cGMP and ISO 13485:2003 regulated manufacturing environments.
* Experience in technical support within medical device manufacturing.
* Six Sigma experience; Green Belt minimum is preferred
* Strong technical writing background with a solid statistics knowledge base related to medical device process validations.
* Experience with data analysis software used to extract and analyze data, MS Access, Excel and Minitab preferred.