Manufacturing Engineer Jobs

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:

• Conducts time studies and adjusts production standards for medical device products as required.
• 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.
• Understands regulatory and industry requirements for medical device manufacturing (GMP, RoHS, REACH, etc.).
• Applies lean manufacturing techniques to reduce medical device manufacturing waste.
• 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.).
• Ability to assist in the design, installation and troubleshooting of basic manufacturing equipment.

• BS/MS in Mechanical/Industrial/Manufacturing/Biology/Chemical/Biochemistry/Biomedical Engineering/Polymer Sciences/Engineering, Mechanical Engineering,Industrial Engineering, Biomedical Engineering, or Science/Aerospace Engineering.