Senior Manufacturing Engineer-Medical Devices

Job Description

Job Description

Senior Project Engineer – Medical Device Contract Manufacturing

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.