This position has the responsibility to generate documentation related to non-product tools and equipment (NPE). The role will be required to work with the new product development team and specifically with Manufacturing Engineering, Quality Engineering, New Product Development Engineering, and Project Management to define requirements, write specifications, helps determine and document calibration and preventative maintenance requirements for NPE associated with major development project. This position will work within an overall project plan but will be expected to help fine tune details for timing and subtasks based on actual work to help keep overall project on track.
• Capture/Define tool and equipment requirements for new product.
• Help capture required overall documentation package for project planning and traceability purposes.
• Development and document specifications based on requirements. Establish calibration and/or preventative maintenance requirements.
• Develop trace matrix.
• Interact with project team, production operators, and other technical staff.
• Help manage to timeline and project deliverables.
• B.A./B.S. in Mechanical Engineering or similar field.
Years Of Experience:
• 3-5 years’ experience as a Manufacturing or Quality Engineer.
• 2-3 years’ experience in a GMP environment.
Specialized Knowledge Required:
• Must have experience in working with multi-disciplinary project teams to achieve manufacturing and quality objectives.
• Experience with document control system, electronic product lifecycle management.
• Experienced with or knowledge engineering specifications and documentation for standard commercial manufacturing processes such as die casting, injection molding, extrusion, machining, and high level assembly.
• The candidate should also be a creative, self-motivated, team player, with excellent writing and communication skills.
• Familiar with quality control and regulatory processes.
• Experience in design/manufacture of medical devices. Knowledge in various manufacturing processes as they apply to the medical device designs.
• Familiar with the FDA’s Design Control process, the CE Mark process, and ISO requirements. Able to comprehend all necessary design control documentation related to a project.
• Demonstrated leadership is a strong plus.
• Demonstrated successful project management skills.
• Excellent verbal and written communication skills.
• Strong analytical and problem solving skills.
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