Manufacturing Engineer III

Manufacturing Engineer

RESPONSIBILITY AND AUTHORITY

This position is responsible for optimizing the manufacturability of products. Under direction of a more senior engineer, design and develop manufacturing processes, tooling, and fixtures in order to meet daily production schedules while enhancing productivity and product quality.

PRIMARY ACTIVITIES

? Design and develop manufacturing processes for new products, product changes and enhancements, and related tooling and fixtures which are consistent with a zero defect level as well as low product cost.
? Perform process validation activities on all manufacturing processes.
? Create and maintain tool drawings and shop orders in coordination with the Quality Assurance and R&D functions.
? Coordinate work of assigned technicians and temporary workers as needed.
? Plan and schedule projects in a manner consistent with corporate objectives.
? Maintain accurate documentation of concepts, designs, and processes.
? Support prototype and pilot production of new products, product changes, and enhancements in coordination with the Manufacturing and Quality Control functions.
? Participate in facilities engineering and planning when appropriate.
? Work with product development staff to ensure that products under development are optimally manufacturable. Work toward resolution of manufacturing issues.
? Maintain GMP systems, including pre-production and postproduction quality assurance.
? GMP compliance in coordination with the Document Control, R&D, and Quality Assurance functions. Complete accurate and timely manufacturing documentation including manufacturing procedures, material records, etc.
? Support company goals and objectives, policies and procedures, Good Manufacturing Practices, and FDA regulations.

MINIMUM REQUIREMENTS AND QUALIFICATIONS

? Minimum of a BS in Manufacturing, Mechanical or Biomedical Engineering
? 1-3 years experience, or MS in Manufacturing, Mechanical or Biomedical Engineering with 1+ years experience.
? Exposure to manufacturing technology.
? Knowledge of standard machine shop equipment.
? Excellent communication skills both verbal and written; ability to communicate technical concepts graphically and written.
? CAD software
? Proficient in MS Office software

DESIRED SKILLS AND QUALIFICATIONS

? Six sigma black belt and/or lean certification
? Manufacturing experience with Class II or III Medical Devices