Manufacturing Engineer

POSITION SUMMARY:

The Manufacturing Engineer is responsible for the development, qualification, verification and validation of manufacturing processes. The Manufacturing Engineer will contribute in a creative and collaborative way to achieve the company's goals of producing market‑lead products through positive patient outcomes.

Team member of projects involving design and manufacturing resources, both internal and external. Specific expectations include:

• Review of component designs and identification of Design for Manufacturing opportunities. Able to identify critical component functions and determine which manufacturing techniques will provide the optimal outcome.
• Review of proposed component tolerances and input to manufacturing capability. Has knowledge of tolerance capabilities of machining, molding, casting, stamping, forming, grinding, etc. Understands GD&T and how to properly apply it to yield the desired fits between joining parts.
• Review of proposed device assembly requirements and identification of Design for Assembly opportunities. Understanding of assembly and joining techniques including laser welding, ultrasonic welding, adhesive bonding, over‑molding, etc. Understanding of error proofing, poke‑yoke.
• Provide input to systems test requirements for ongoing production.
• Definition of high‑level manufacturing system/flow.
• Selection of suppliers for parts and equipment.
• Coordination of parts and equipment fabrication.

• Knowledge of general manufacturing technologies including low to medium volume manufacturing processes.
• Work with outside suppliers to define, document, analyze and qualify their manufacturing processes.
• Identify new vendors, processes, materials, and technologies that can be used to improve product quality and reduce product cost.
• Lead the definition, development, verification, and validation of manufacturing processes for new products. Develop manufacturing processes that are simple, cost‑effective and reliable.
• Identify and implement manufacturing and product‑related cost reduction opportunities. Understand life‑cycle costs and cost‑benefit analysis.
• Familiar with manufacturing efficiency strategies such as Lean, Six Sigma, 5S, Value Stream mapping, etc.

• Able to define, communicate, and develop fixture concepts using internal and external resources. Able to incorporate the capabilities of typical production association into these concepts.
• Understanding of ergonomics as related to repetitive stress injuries.
• Work with designers and engineers in the design and development of manufacturing‑related equipment and fixtures.
• Define and track project tooling and equipment schedule and cost.
• Responsible for proper installation of new equipment, and setting up proper preventive maintenance and calibration plans.

• Responsible for developing detailed process qualification strategies. Able to define statistical sample sizes as related to variable and attribute data, based on established company and industry standards.
• Responsible for developing detailed Process FMEAs and using the output to develop robust manufacturing processes. Also using the output to determine in‑process testing and product final inspection requirements.
• Responsible for writing and executing process qualification protocols and reports. Understanding of IQ, OQ, and PQ approach as defined by Atri Cure Quality System.

• Understand supply chains, lead times, and raw material availability.
• Responsible for make vs. buy decisions on parts and processes.
• Able to construct Bills of Material, with proper unit of measure and inventory points.
• Working knowledge of MRP and other requirement planning systems.
• Able to create manufacturing routers. Understands labor collection and work centers.
• Understanding of standard costing and variances. Able to conduct time studies and analyze cost variances.

• Properly document all work in compliance with Atri Cure Quality System requirements.
• Responsible for process documentation release using tools such as Visio, Excel, Word, Procal and Master Control documentation…