Manufacturing Engineer

Job Description:

The Manufacturing Engineer applies knowledge of continuous improvement to enhance manufacturing quality, reliability, and cost-effectiveness. May design, or work with designers to refine product designs, to increase manufacturability, and decrease costs

Essential Duties and Responsibilities:

Applies lean manufacturing techniques to reduce medical device manufacturing waste.

Conducts time studies and adjusts production standards for medical device products as required.

Understands regulatory and industry requirements for medical device manufacturing (GMP, RoHS, REACH, etc.).

Ability to assist in the design, installation and troubleshooting of basic manufacturing equipment.

Identifies root cause of failures using statistical methods and recommends changes in designs, tolerances, or processing methods.

Works to develop a detailed understanding of customer requirements for new product launches and product sustainment. Completes all documentation required for PPAP submittal (FAI, PFMEA, SOP, etc.).

Properly drafts and submits ECRs and SICRs internally and externally to document changes to products or processes.

Performs validations (IQ/OQ/PQ activities) on products to ensure proper performance to designated specifications. Drafts, executes, and reports validation protocols internally and externally.

Qualification:

Must have 1-2 years of Manufacturing Engineering experience.

Must have done BS/MS in Mechanical/Industrial/Aerospace Engineering.

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