The Manufacturing Process Engineer will support in new product launches, manufacturing & process improvement initiatives, process & test method development and validations (IQ, OQ, PQ & TMV). He/She appreciates an environment where superior work is encouraged, noticed and rewarded and where individuals carry tremendous responsibility.
Essential Job Duties and Responsibilities
• Process Development
o Assist in development, testing and improve manufacturing processes for new and existing products that will reduce operating costs, reduce labor, reduce product variability and increase yields.
o Assist in planning, coordinating, developing and executing test protocols, experiments, process characterization and process validations (IQ, OQ, PQ) on new and revised products and processes.
o Assist in writing and updating standard operating procedures and other documentations required for the completion of the validation.
• Manufacturing Operations Support
o Support internal customers including but not limited to Manufacturing, Sales, Quality and others as necessary.
o Provide timely resolution of product, process and equipment problems in the form of creative short and long term solutions.
o Assist in technical support and troubleshooting for manufacturing and extrusion operations.
o Monitor manufacturing variances so that problem solving and improvement opportunities are identified.
o Stay current with and ensure appropriate QA/RA SOP’s are followed on all projects, including: product/process development process, process controls, process validations, and ECO system.
o Provide support as required to GMP, safety, ISO and internal audits.
o May perform other duties as assigned
Education and Experience
• Bachelors Level of Degree in the Mechanical, Polymer or Plastics Engineering.
• Minimum of 3 years engineering experience.
• Medical device experience preferred with knowledge of ISO FDA and cGMP regulations.
• Strong initiative – self-directed and takes action on opportunities.
• Experience creating and writing procedures, process/equipment IQ/OQ/PQ validations, including test method validations are preferred.
• Computer skills required include Microsoft PowerPoint, Excel & Word. Project and Minitab are preferred.
• Ability to effectively communicate both internally and externally.
• Strong organizational skills.