**Main Purpose of Job**:
- Under the direction of the Director of Manufacturing Engineering, Engineering Manager (Product Launch or Sustaining), Value Stream Manager (VST) or Designee, is responsible for:
- Providing engineering support to all required manufacturing/engineering areas in order to improve processes and provide immediate solutions to any problems that may affect process performance in areas such as assembly, printing, quality, special projects, etc.
- Supporting the engineering and technical needs of the campus and customers (strategic and tactical, such as value improvement projects, new process / equipment, etc.).
- Designing and implementing fixturing, tooling and methodologies to support manufacturing and production efficiencies.
- Analyzing current manufacturing methods and practices in order to identify opportunities to eliminate non-value added steps; recommending, developing and prototyping new processes and production methods to enhance manufacturing. Discerning when and how to use Lean Manufacturing techniques: 5S, waste identification and elimination, value stream mapping, Kaizen, error proofing, one piece flow, set-up time reduction, Kanban, balanced work flow, etc.
- Providing team leadership support for process improvement projects involving quality, productivity and cost reductions.
- Supporting product launches across the campus.
- The validation, implementation and controls to support manufacturing process transfers, relocations and changes.
- Analyzing current project plans and execute accordingly, ensuring achievement of expected quality levels, customer satisfaction and financial goals.
Main Job Duties/Responsibilities
- Support, promote and enforce safety across the campus. Support and promote the overall EHS initiatives and programs.
- Follow all Good Manufacturing Practices (GMP's) and Standard Operating Procedures (SOP's) as defined by MedPlast's policies, practices and procedures to ensure that FDA and ISO regulations along with MedPlast quality standards are met.
- Identify processes improvements and as applicable; plan, design and implement methods (including line/workstation reconfigurations, tools, fixtures and others) to meet quality specifications and productivity goals of the current and/or new business supported. Continuously seek for product/process improvement projects, relevant to Lean Manufacturing and Innovation.
- Provide budgetary, costing and other data to support the decision making process prior to the implementation of a new process or process change.
- Drive product/process compliance investigations for non-conformances (NCs), Corrective and Preventive Actions (CAPAs) and Internal/External Audits; and ensure timely completion and effectiveness of implemented actions.
- Prepare and present reports on accomplished tasks. Perform applicable recommendations based on those reports.
- Create, update and optimize manufacturing line layout and material flow.
- Perform project management responsibilities for assigned manufacturing process changes, sustaining projects and the introduction of new products to existing lines (mainly for sustaining of existing manufacturing processes). Coordinate activities for implementing changes to existing manufacturing processes with the applicable departments.
- Coordinate and carry out qualification and validation activities for new products, processes, changes and transfers as per FDA or other applicable regulations (IQs/OQs/PQs/PPQs/TMVs). Prepare validation protocols and reports for low and moderate complexity qualifications.
- Perform revalidation assessments for changes requested for validated processes.
- Participate on product/process development or characterization stages as required.
- Maintain constant communication with internal and external stakeholders regarding customer satisfaction and feedback on products and processes. Take actions on duties outlined under his/her responsibility when applicable.
- Conduct and/or coordinate troubleshooting activities for the repair of machinery and equipment used in the manufacturing process.
- Customer service: Communicates with external customers under supervision. Lead technical meetings with internal customers and suppliers.
- Perform other duties, tasks, or projects at the direction of immediate supervisor and not limited to the job category.
Knowledge / Education
- Minimum education required to perform duties: Bachelor degree in Engineering (i.e. Mechanical, Manufacturing, Industrial Engineering or science related engineering discipline, etc.)
- Bilingual English/Spanish - Intermediate English level, reading and listening comprehension, writing and oral expression.
Job Experience
- At least 2 years of experience in a manufacturing environment.
- Project Management experience is a plus.
- Additional Knowledge as a Plus
- Proficient in CAD software (AutoCad or SolidWorks) is a plus.
- Proficient in 3D modeling CAD software (SolidWorks) is a plus.
- Knowledge of Six