As a Process Engineer you will leading the redevelopment of the manufacturing area providing production support and process improvement of high speed automated equipment, and custom, semi-automated equipment to manufacture analytical tests. You will conduct process development for new and existing products by utilizing Six Sigma/DMAIC and Lean methodologies to drive efficiency and solve problems. Target corrective actions, verification/validation activities, and process and quality improvements.
You will work collaboratively with the automation and equipment maintenance teams to learn processes, equipment, current controls in place and will then play an integral part of defining the future state of our manufacturing area.
What will I do?
Utilize Lean, Six Sigma and other quality and reliability improvement techniques in ongoing work, and participates in related projects.
Support continuous improvement activities to meet service cost, quality and schedule goals. Develops methods for handling and processing of materials to comply with design, manufacturing and safety requirements.
Resolve manufacturing/service problems. Perform on-going problem solving and process refinement support in collaboration with internal personnel and suppliers.
Recommend and justifies equipment/tools used for processing material, and manages implementation to meet cost, quality and schedule goals. Utilize appropriate levels of verification and validation when qualifying and implementing new tools or processes.
Ensure processes remain ISO compliant. Develop specifications associated with process outputs, and defines test methods for specification compliance.
Manage tasks and projects through to successful completion and attainment of goals.
Generate SOPs/work instructions and conducts training of personnel in the methods and techniques used.
Work with product development teams to provide support and services in areas of functional and skill expertise. Learn and becomes expert on the technical aspects of the product(s) in area(s) of responsibility.
Coordinate with other functional areas to plan and implement work, and exchange information. Coordinate with outside vendors and suppliers as needed.
What you need to succeed: 3+ years of experience. 4-year Engineering degree or equivalent combination of education and experience required. Experience using Statistical Process Control systems (SPC) in a manufacturing environment. Experience working on teams in support of projects to improve productivity, yield and/or cost in a high-volume manufacturing environment. Familiarity with and ability to learn Lean and Six Sigma principles and techniques. Work with design verification/validation, process validations, and change management procedures. Understand manufacturing process documentation and perform updates as needed. Read, analyze and interpret standards (e.g., ISO 9000), specifications, professional journals and technical procedures. Manage multiple priorities and tasks and projects through to successful completion and attainment of goals. Communicate to technical and non-technical personnel verbally and in writing. Work independently and collaboratively as members of cross-functional teams. Strong verbal and written communication skills, including presentation skills, ability to communicate technical data, technical writing skills and ability to create standard operating procedures (SOP’s) and work instructions understandable by various levels in organization. Learn technical aspects of products in area(s) of responsibility. Problem solving ability associated with product development, manufacturing or other technical issues. Ability to identify problems, collect data, establish facts, draw valid conclusions and implement solutions. Ability to organize and manage multiple priorities. Knowledge of ISO, GMP, quality audit, safety and environmental requirements. General computer skills, with proficiency in MS Office (Word, Excel, PowerPoint, Visio, Project), JMP and other engineering software as required. Some working knowledge of SAP preferred.
Occasionally required to climb, balance, bend, stoop, kneel or crouch. May be required to lift, move and carry up to 50 pounds. Work with exposed moving electro-mechanical parts. Work with exposed electrical power requiring proper protective equipment. Office, engineering lab and industrial environments requiring safety, electrostatic discharge (ESD), clean room and other equipment. Additional work with electrical solder and fluxes, exposure to supplier assembly processes using chemicals, with machinery noise. Exposure to a normal laboratory setting with varying levels of noise and exposure to various potential chemical and biological hazards. Personal protective equipment will be utilized as required. The use of Good Laboratory Practices is a requirement.