Description: PDS Tech, Inc. is seeking a candidate for the Manufacturing/Industrial Engineer 3 position located in Mishawaka, IN.
The Mechanical Engineer is responsible for providing technical and design expertise on a production and facility consolidation project. This individual will undertake detailed engineering design of production equipment while preparing user requirements, design documentation and verification/validation protocols. Engineer will collaborate with project managers, associates, project architects and engineering consultants while attending meetings to ensure that design and project work are carried out within agreed upon deadlines and budgets. The estimated duration for this position is 2 years. The Mechanical Engineer will report directly to the Project Manager. • Participate in semi-complex material specification, schematic preparation and appropriate follow-up. • Provides support in semi-complex design, development, testing and modifications of solutions. • Provides support in preparing explanations and clarifies information to enable proper interpretation and evaluation of semi-complex specifications, performance characteristics or other technical data. • Authors user requirements (URS) and validation protocols for custom production equipment. Responsibilities • Establish and maintain compliance with internal corporate, ISO and FDA guidelines. • This person will also actively participate on cross-functional teams and work to enhance the systems and procedures that result in improved packaging process. The position also requires interaction with outside material, manufacturing line, and automation/integration machine vendors. Research new and existing package compliance issues while providing project leadership and technical expertise. • This person needs to facilitate communication with company employees, establish project plans, track, manage and provide updates in accordance with project schedule. • Participate in the on-going evolution and enforcement of the Quality Policy.
Required Knowledge/Skills, Education, and Experience: • Bachelor Degree in Mechanical Engineering (or equivalent degree, knowledge and skills in Mechanical Engineering, Materials Engineering, Industrial Engineering or Package Engineering) • A minimum of four (4) years of related professional work experience and (2-3) years ISO or GMP or GLP experience. • Some travel required with this position (5%) • Proven experience in lean manufacturing especially with regards to process waste reduction and elimination and process improvement • Ability to interface with diverse work groups and ability to work independently, taking initiative and driving projects to completion. • Ability to create documentation using CAD software, Word Processing, Project Planning, Solid Works and Spread Sheet Software. • Good written and verbal communication skills. Preferred Knowledge/Skills, Education, and Experience • Strong emphasis on web handling, material drying processes, slitting processes, and packaging processes. • Experience in either pharmaceutical, diagnostics or food packaging industry is desired. • Strong background in extreme moisture control especially with sealing processes, material selection to maintain or improve current vapor barrier (MVTR) and strong background on the type and use of desiccants. • ISO9001/ISO13485 experience preferred.