Sr Process Improvement Engineer

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 Patty.Diaz@kellyengineering.com #J-18808-Ljbffr