Bachelor's degree in Mechanical or Manufacturing Engineering or equivalent experience
5-10 years of experience in production, manufacturing engineering, or operations leadership
Experience in medical device manufacturing
Strong hands-on knowledge of CNC machining methods (milling, turning, Swiss-turning)
Working knowledge of G-code/M-code, Mastercam, and tooling selection
Solid understanding of GD&T (ASME Y14.5)
Familiarity with ISO 13485 and FDA 21 CFR 820
Responsibilities
Lead Lean Manufacturing and Continuous Improvement initiatives for measurable quality, cost, productivity, and sustainability gains
Collaborate with CNC machinists, setup technicians, engineers, and leaders to optimize processes
Analyze production data using ERP systems to identify trends and improvement opportunities
Champion Kaizen events, Six Sigma projects, and Lean deployments from concept to execution
Investigate and implement new manufacturing technologies, tools, and fixtures
Perform root cause analysis and implement corrective actions
Mentor and train operations teams on Lean principles to enhance continuous improvement culture
Support new product introductions, plant layouts, and process validations
Benefits
Opportunity to work in a leading medical device manufacturing environment
Role in continuous improvement initiatives that can impact organizational sustainability
Possibility to mentor and train others, enhancing leadership skills
Exposure to cutting-edge manufacturing technologies and methodologies
Participation in cross-functional teams promoting operational excellence
Full Job Description
What You'll Do (Your Impact)
You'll be a driving force behind safer, smarter, and more efficient manufacturing processes:
Lead Lean Manufacturing and Continuous Improvement initiatives that deliver measurable gains in quality, cost, productivity, and sustainability
Partner closely with CNC machinists, setup technicians, engineers, and leaders to optimize cycle times, tooling, and workflows
Analyze production data using ERP systems (Epicor preferred) to identify trends, root causes, and improvement opportunities
Champion Kaizen events, Six Sigma projects, and Lean deployments from concept through execution
Investigate and implement new manufacturing technologies, tools, and fixtures
Perform root cause analysis and corrective actions on internal and external issues
Mentor and train operations teams on Lean principles, fostering a culture of continuous improvement
Support new product introductions, plant layouts, and process validations
Serve as a key member of the plant leadership team, promoting safety, teamwork, and operational excellence
What You Bring
You're a blend of technical expert, coach, and change agent:
Bachelor's degree in Mechanical or Manufacturing Engineering (strongly preferred), or equivalent experience
10+ years of experience in production, manufacturing engineering, or operations leadership
Experience in medical device manufacturing
Strong hands-on knowledge of CNC machining (milling, turning, Swiss-turning)
Working knowledge of G-code/M-code, Mastercam, cutters, inserts, and tooling selection
Solid understanding of GD&T (ASME Y14.5)
Familiarity with ISO 13485 and FDA 21 CFR 820
Proven leadership, project management, and facilitation skills
Comfort working cross-functionally with Quality, Engineering, Inventory, Maintenance, and Leadership
Salary Range: $95,000-120,000
About Smiths Machine
Smiths Machine is a manufacturing company that specializes in precision machining and assembly services. The company was founded in 1980 and is headquartered in Indianapolis, Indiana. Smiths Machine has a team of experienced machinists and technicians who use state-of-the-art equipment to produce high-quality parts and components for various industries, including aerospace, defense, medical, and transportation. The company's services include CNC machining, turning, milling, grinding, and assembly. Smiths Machine is committed to providing its customers with high-quality products and services and has a reputation for delivering on-time and on-budget.
