Manufacturing Engineer

TL;DR

Manufacturing Engineer (Medical Devices): Design and develop new and improved manufacturing processes for orthopedic foot & ankle products with an accent on efficient design transfer, process validation, and quality assurance. Focus on evaluating processes, implementing Lean improvements, and ensuring compliance with FDA/ISO standards under high-quality requirements.

Location: Houston, Texas (onsite)

Company

Innovation-driven medical technology growth company dedicated to clinically differentiated solutions in orthopedics for better patient outcomes.

What you will do

• Manage adherence to procedures to ensure product quality meets or exceeds goals
• Evaluate and develop manufacturing processes by researching, designing, and testing methods and equipment
• Serve on cross-functional teams as manufacturing expert for new product introductions
• Assure product and process quality through testing methods, standards, and validation protocols
• Execute CAPA, project management, and quality systems deliverables with proper documentation
• Maintain equipment, train staff, and participate in Kaizen events and Lean initiatives

Requirements

• Bachelor’s degree in science, BSME, or related engineering field
• Minimum 2 years of experience in process or manufacturing engineering
• Must have full-time work authorization in the United States, both now and in the future, without requiring sponsorship
• Ability to work in office and manufacturing environment, sit/stand for extended periods

Nice to have

• Experience in orthopedic medical device manufacturing
• Knowledge of DFM, Lean, DOE, Process Validation, FMEA, Six Sigma
• Proficiency in CAD (SolidWorks, MasterCAM, AutoCAD), Minitab, CMMs, Vision Inspection
• Familiarity with FDA regulations (21CFR 820), ISO 13485, GD&T ASME Y14.5M
• Master’s degree or metals/plastics machining experience

Culture & Benefits

• Comprehensive benefits: medical, dental, vision insurance; 401(k) plan
• Vacation, sick leave, holidays; income protection plans
• Spending/savings accounts, discounted insurance rates, legal services
• Culture of continuous improvement, collaboration, and scientific excellence
• Climate-controlled workspace in office and manufacturing environment