Sr Process Improvement Engineer

Kelly Science, Engineering, Technology & Telecom; Wheeling (IL); On-site; USD 90,000 - 120,000; Full time

Job summary

A reputable medical device manufacturer in Wheeling, IL is seeking a Senior Process Improvement Engineer who excels in hands-on manufacturing roles. This position involves optimizing processes to enhance efficiency and leading initiatives like Lean and Kaizen directly on the production floor. Candidates should have 7–12 years of experience in FDA-regulated environments, showcasing strong leadership in process improvement. The role requires a proactive approach to driving quality and regulatory compliance, making a significant impact on the organization.

Qualifications

• 7–12 years of hands-on experience in FDA-regulated medical device manufacturing.
• Proven leadership in process improvement within a manufacturing environment.
• Strong Lean / CI mindset with real execution experience.

Responsibilities

• Redesign and optimize manufacturing processes to reduce waste.
• Lead Lean, Kaizen, and CI initiatives on the production floor.
• Drive RCA, CAPA, and FMEA for quality and process issues.

Skills

Process improvement leadership

Lean methodologies

Cross-functional team leadership

Job description

Overview

Senior Process Improvement Engineer | Medical Device Manufacturing

Kelly Engineering is partnering with a well-established, FDA-regulated medical device manufacturer in Wheeling, IL to hire a Senior Process Improvement Engineer who thrives on the manufacturing floor and knows how to turn inefficiency into results.

This is not a theory-only role.

This is hands-on, visible, and impactful.

What You’ll Be Doing

• Redesign and optimize manufacturing processes to reduce waste and bottlenecks
• Lead Lean, Kaizen, and CI initiatives directly on the production floor
• Drive RCA, CAPA, and FMEA for quality and process issues
• Support tech transfer and regulatory-driven process changes
• Improve workflow, layouts, and resource utilization
• Prepare for and support FDA, QSR, and ISO 13485 audits

What We’re Looking For (Must-Haves)

• 7–12 years of hands-on experience in FDA-regulated medical device manufacturing
• Proven process improvement leadership in a production environment
• Strong Lean / CI mindset with real execution experience
• Experience with Class II / 510(k) devices
• Comfortable leading cross-functional teams and owning outcomes

Bonus Experience

• Change control and tech transfer exposure

⚠ Please note: Candidates without direct medical device manufacturing experience will not be considered.

Interested or curious?

Apply directly or message me directly at [e-mail]