MedTech Manufacturing Engineer — Lean Process Innovator

EXALTA Group; Florida; On-site; USD 85,000 - 110,000; Full time

Job summary

EXALTA Group in Bonita Springs, FL, is seeking a Manufacturing Engineer to design, develop, validate, and continuously improve precision medical-device manufacturing processes. The role protects product quality, manufacturability, and cost while guiding engineering teams from concept to production.

50% office and 50% shop floor, ISO 13485 experience preferred. The position requires strong project leadership, process validation (IQ/OQ/PQ), and cross-functional collaboration with RD, QE, and

Qualifications

• Bachelor's degree in Engineering is required.
• Experience in medical device manufacturing is preferred.
• Strong problem-solving and project-management skills.

Responsibilities

• Act as project manager and point of contact for engineering projects.
• Develop PFMEA, control plans, and validation activities.
• Create manufacturing processes, routers, and BOMs.
• Lead process improvement through lean methods to reduce cost and lead time.
• Collaborate with R&D and engineering on testing protocols.
• Support CAPA and complaint processes to closure.
• Ensure manufacturability, quality, and cost targets are met.

Skills

CNC machining

SolidWorks

Lean manufacturing

Six Sigma

GD&T

Process improvement

Education

Bachelor's degree in Engineering

Job description

EXALTA Group in Bonita Springs, FL, is seeking a Manufacturing Engineer to design, develop, validate, and continuously improve precision medical-device manufacturing processes. The role protects product quality, manufacturability, and cost while guiding engineering teams from concept to production.

50% office and 50% shop floor, ISO 13485 experience preferred. The position requires strong project leadership, process validation (IQ/OQ/PQ), and cross-functional collaboration with RD, QE, and