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
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