Job Description

Neo Medical, Inc. a subsidiary of CHS USA Inc., is hiring Manufacturing Enginee r.

The Manufacturing Engineer will be responsible for managing engineering responsibilities of product and manufacturing activities, ensuring compliance to QSR, CMDR, and ISO 13485 standards, and also to perform any other assigned duties

Major Responsibilities:

• Design and test new Equipment, Tooling, Fixtures, Processes, Procedures and Systems.
• Ensure that key elements of the quality policies are understood, implemented, and maintained at all levels of the manufacturing organization.
• Maintain all Manufacturing related Controlled Drawings.
• Perform testing per test protocols and/or inspection procedures.
• Perform inspection of incoming production components and complete associated paperwork.
• Maintain an effective filing system for inspection records.
• Transfer production materials to operations and complete associated paperwork.
• Assist in New Product Development Projects as assigned.
• Assist in conducting tests for process validations and process improvements.
• Perform in-process and final inspections as required.
• Prepare Inspection Rejection Reports as required.
• Perform and complete material rejection reports as required.
• Assist in coordination of calibration efforts and maintaining calibration records.

Reports to: Engineering Manager

Requirements:

One to Five years of mechanical engineering experience, with a significant portion in manufacturing development. Experience in medical devices considered a plus.

• Well organized, self-starter, good leadership and communication skills, innovative problem solver, mature, interested in teaching and learning.
• Demonstrated knowledge of development, manufacturing, and quality systems requirements for medical devices a plus.
• Education: BSME or equivalent required.
• Knowledge and experience appropriate to the tasks assigned to them, about risk assessment and / or risk management generally and as applicable to medical devices being manufactured, their use, and the technologies involved.
• Full bilingual proficiency in Spanish and English is required.

Pay range: $65,000.00 - $70,000.00 per year

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