Manufacturing Engineer – Medical Device Processes & Lean

EXALTA; Florida; On-site; USD 85,000 - 125,000; Full time

Job summary

EXALTA is seeking a Manufacturing Engineer in Bonita Springs, FL to design, develop, validate, and continuously improve manufacturing processes for precision medical-device components.

You will lead process improvement, validation activities, and collaborate with R&D, QE, and production to ensure quality, manufacturability, and cost targets. The role requires 7+ years of experience and strong knowledge of CNC machining, Lean, and SPC.

Qualifications

• Bachelor's degree in Engineering or related field.
• Minimum 7 years of manufacturing engineering experience.
• Experience in medical device manufacturing preferred.
• Strong knowledge of GD&T and blueprints.

Responsibilities

• Lead projects and serve as customer point of contact.
• Develop PFPs, PFMEAs and control plans.
• Review orders and determine processing requirements.
• Develop processes and routers aligned with QA and BMI SOPs.
• Lead validation activities (IQ/OQ/PQ) and CAPA processes.

Skills

CNC machining

Lean Manufacturing

Six Sigma

Root cause analysis

Project management

Cross-functional leadership

Communication skills

Problem solving

Education

Bachelor's degree in Engineering

Tools

SolidWorks

Epicor

Microsoft Office

Job description

EXALTA is seeking a Manufacturing Engineer in Bonita Springs, FL to design, develop, validate, and continuously improve manufacturing processes for precision medical-device components.

You will lead process improvement, validation activities, and collaborate with R&D, QE, and production to ensure quality, manufacturability, and cost targets. The role requires 7+ years of experience and strong knowledge of CNC machining, Lean, and SPC.