This role supports manufacturing operations in the areas of process development, tool design, machine programming, machinery & equipment acquisition, manufacturing layout, continuous improvement and other duties associated with engineering support of production
ENGINEERING DUTIES AND RESPONSIBILITIES:
- Participates in engineering projects including developing and executing to the plan and schedule and meeting the goals and objectives of the project. Assists in tracking costs, preparing status reports, conducting meetings, and documenting and communicating progress to management.
- Participates in investigations, develops plans and executes tasks to solve process problems including Nonconformances (NC), complaint investigations, audit observations and Corrective and Preventive Actions (CAPA).
- Provides day to day support and direction to production such as, but not limited to turning, milling, drilling, EDM, finishing, packaging etc. as required.
- Executes engineering studies and process validation protocols and summary reports (Installation Qualification, Operation Qualification, Performance Qualification, Computer Software Validation and Test Method Validation).
- Identifies and assists in process improvements for existing manufacturing processes utilizing appropriate engineering principles and standard strategies such as, Lean and Six Sigma principles.
- Assists in gage design, measurement system analysis, and gage implementation as required. Is able to use various types of measuring instruments including, micrometers, calipers, comparators, tensile testers, coordinate measurement systems etc. to support engineering testing.
- Assists in developing fixtures and designing tools and has the ability to express and implement ideas with tool designers.
- Supports new equipment acquisition efforts including user requirement specifications, machine selection, installation, validation, employee training, and other related equipment responsibilities as required.
- Assists in the development of manufacturing and inspection procedures.
- Participates in cross-functional teams which may include, but are not limited to Manufacturing Engineering, Production, Quality Assurance, Finance, and Product Development.
- Acts as a liaison to vendors with regard to contracted products, tools & fixtures, and their manufacture.
- Performs other related duties, as required.
EDUCATION AND EXPERIENCE REQUIREMENTS:
- Bachelor of Science Degree from accredited institution (or AS degree and actively pursuing BS degree) in Manufacturing Engineering, Mechanical Engineering, Industrial Engineering, or a related degree.
- Previous experience in manufacturing and/or engineering, working in a regulated industry, such as Medical Device is preferred is preferred.
Demonstrates strong organizational, project management, computer, written, verbal and presentation skills
- Must be willing to support 2nd and 3rd shifts.
- Participates in and understands compliance related activities pertaining to the job assignment including compliance with the Quality System Regulation (QSR), Standard Operating Procedures (SOP), and applicable Work Instructions.
- Works in conditions that may be hot, cold, wet and/or noisy along with exposure to fumes, oil, coolants and other manufacturing related chemicals.
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