Senior Manufacturing Engineer-Medical Devices

Position Summary: We are seeking an experienced Senior Project Engineer to lead new product introductions, manufacturing engineering projects, process improvements, and customer programs within a precision medical device manufacturing environment. This is a hands-on engineering role requiring strong experience with CNC machining, Matsuura machining centers, RoboDrill mills, Wire EDM, GD&T, tooling, fixturing, and process development. The Senior Project Engineer will work closely with customers, Quality, Manufacturing, and Operations to take products from prototype through validated production.

Key Responsibilities: Lead engineering projects from customer requirements and prototype through production release. Serve as the technical point of contact for assigned customer programs. Review customer drawings, CAD models, specifications, tolerances, and manufacturing requirements. Develop and optimize CNC machining processes for complex, tight-tolerance medical components. Program, troubleshoot, and improve Matsuura and RoboDrill CNC machining centers. Program, set up, troubleshoot, and optimize Wire EDM processes. Develop tooling, fixtures, workholding, setup sheets, routings, work instructions, and manufacturing processes. Select cutting tools, feeds, speeds, machining sequences, and process strategies. Troubleshoot dimensional, surface-finish, tooling, cycle-time, and process-stability issues. Lead technical activities for New Product Introduction (NPI), including prototype and first-article builds. Support quoting by developing labor, tooling, programming, fixturing, and manufacturing assumptions. Lead or support PFMEA, process validation, IQ/OQ/PQ, root-cause analysis, and continuous-improvement activities. Support ECOs, nonconformances, CAPAs, and other engineering/quality activities. Work within FDA, ISO 13485, customer, and internal Quality Management System requirements. Partner with machinists, operators, Quality, customers, suppliers, and management to resolve manufacturing challenges. Mentor less-experienced engineers and serve as a senior technical resource.

Qualifications: Bachelor's degree in Mechanical, Manufacturing, Industrial Engineering, or related field; significant relevant experience may be considered in place of a degree.5+ years of experience in manufacturing engineering, project engineering, precision machining, or a related field. Strong hands-on CNC machining and programming experience. Experience with Matsuura and RoboDrill CNC machining centers. Experience programming and operating Wire EDM equipment. Strong knowledge of GD&T and complex engineering drawings. Experience with CAD/CAM software and CNC programming. Strong understanding of tooling, workholding, feeds and speeds, materials, and machining processes. Experience manufacturing complex, tight-tolerance components. Medical device, aerospace, or other highly regulated manufacturing experience strongly preferred. Experience with process development, validation, root-cause analysis, and continuous improvement. Strong project-management, problem-solving, and communication skills. Ideal candidates are equally comfortable managing customer engineering projects and working hands-on with CNC and EDM manufacturing processes.