Manufacturing Engineer II - Lean, GMP & Process Improvement

Viant Medical Inc.; Wheeling (IL); On-site; USD 90,000 - 100,000; Full time

Benefits offered by this job

Medical, dental, vision benefits

Company-paid life insurance

Paid time off & holidays

401k with company match

Tuition reimbursement

Pet Insurance

Job summary

Viant Medical Inc. in Wheeling, IL invites applications for a Manufacturing Engineer role focused on continuous improvement of equipment and processes.

You will design, test, and implement improvements, validate equipment, and resolve production issues while upholding GMP standards. The position requires a Bachelor’s in Engineering, 5+ years in engineering, and expertise in machining (CNC/Swiss), ISO13485, Lean Six Sigma, PFMEA, Minitab, and SolidWorks.

Qualifications

• Bachelor’s Degree in Engineering or related field.
• 5+ Years of experience in Engineering role.
• Medical, Aerospace, Pharms or Military Mfg. experience.
• Machining Environment, CNC, Swiss, Lathes or Grinders.
• Advanced understanding of ISO13485, Lean Six Sigma, PFMEA, Minitab, Oracle Configuration, Process/Equipment Validation, NPI, Root Cause Analysis and SolidWorks.
• Good Manufacturing Practices.
• Designs of Experiments (DOE).
• Proficiency in Microsoft Office Software.
• Project Management and Lean Manufacturing experience.
• Excellent knowledge of statistical tools and SPC knowledge preferred.

Responsibilities

• Follow GMP practices, SOPs, and quality policies.
• Troubleshoot production, process, equipment, and quality issues.
• Lead root cause investigations and CAPAs to improve quality and productivity.
• Develop, validate, and maintain manufacturing processes and equipment.
• Support changes, new product introductions, and process validations (IQ/OQ/PQ).
• Create and maintain manufacturing documentation and process controls.
• Drive Lean initiatives to reduce waste and costs while increasing throughput.
• Manage projects on process improvements, fixture design, and material flow.
• Collaborate with Quality, Operations, suppliers, and customers to resolve challenges.
• Ensure safety, ergonomics, and regulatory compliance; conduct data-driven analyses.

Skills

GMP knowledge

Lean Six Sigma

Root cause analysis

DOE

Statistical tools

Project management

Communication skills

ISO13485

Minitab

SolidWorks

SPC

Education

Bachelor’s Degree in Engineering

Tools

Minitab

SolidWorks

Oracle Configuration

MS Office

Job description

Viant Medical Inc. in Wheeling, IL invites applications for a Manufacturing Engineer role focused on continuous improvement of equipment and processes.

You will design, test, and implement improvements, validate equipment, and resolve production issues while upholding GMP standards. The position requires a Bachelor’s in Engineering, 5+ years in engineering, and expertise in machining (CNC/Swiss), ISO13485, Lean Six Sigma, PFMEA, Minitab, and SolidWorks.