MedTech Manufacturing Engineer – Process & Quality

Exalta Group; Hunters Ridge (FL); Vor Ort; USD 80.000 - 110.000; Vollzeit

Zusammenfassung

EXALTA Group in Bonita Springs, FL is seeking a Manufacturing Engineer to design, develop, validate, and continuously improve manufacturing processes for precision medical-device components. You will lead process improvements, validations, and cost-focused manufacturing strategies.

The role requires 7+ years in manufacturing engineering, strong knowledge of Lean/Six Sigma, GD&T, SolidWorks, and ERP systems.

Qualifikationen

• Bachelor's degree in Engineering required.
• Proven experience in manufacturing engineering in machining/production.
• Strong knowledge of Lean/Six Sigma and continuous improvement.
• Experience with GD&T, blueprints, and SPC is a plus.
• Proficient with SolidWorks and ERP systems (Epicor).
• Experience in ISO 13485 and FDA 21 CFR820 preferred.
• Ability to manage multiple projects and work in a team environment.

Aufgaben

• Act as project manager and customer point of contact for projects and technical information.
• Develop PFMEA, control plans and manufacturing routes.
• Review orders and determine processing requirements for cost-effective production.
• Develop procedures and validations for manufacturing processes and equipment.
• Lead process improvement and CAPA activities with cross-functional teams.
• Apply lean tools to reduce waste and lead time while maintaining quality.
• Create part numbers, BOMs, and routings in ERP; review prints for manufacturability.

Kenntnisse

Project management

Lean manufacturing

Root cause analysis

GD&T

SolidWorks

Quality systems

Cross-functional teamwork

Ausbildung

Bachelor's degree in Engineering

Tools

Epicor ERP

Jobbeschreibung

EXALTA Group in Bonita Springs, FL is seeking a Manufacturing Engineer to design, develop, validate, and continuously improve manufacturing processes for precision medical-device components. You will lead process improvements, validations, and cost-focused manufacturing strategies.

The role requires 7+ years in manufacturing engineering, strong knowledge of Lean/Six Sigma, GD&T, SolidWorks, and ERP systems.