Manufacturing Engineer (MedTech)

TL;DR

Manufacturing Engineer (MedTech): Design and develop new and improved manufacturing processes for orthopedic medical devices with an accent on efficient design transfer and process optimization. Focus on leading cross-functional teams to implement manufacturing methods, ensuring adherence to quality systems, and driving Lean/Kaizen initiatives.

Location: Houston, Texas (onsite). Must have full-time work authorization in the United States; no sponsorship provided.

Company

An innovation-driven medical technology growth company dedicated to developing clinically differentiated solutions for orthopedics.

What you will do

• Design and develop new and improved manufacturing processes to ensure effective product design transfer into production.
• Lead cross-functional teams to implement manufacturing processes and drive improvements across various platforms.
• Ensure product and process quality by designing testing methods and confirming process capabilities.
• Manage critical documentation including BOMs, Routers, and FMEAs to meet quality systems requirements.
• Write and review validation protocols and reports applicable to new manufacturing processes.
• Coordinate equipment maintenance and train staff on testing and manufacturing procedures.

Requirements

• Bachelor’s degree in BSME, science, or a related Engineering degree.
• Minimum of 2 years of experience in a process or manufacturing engineering role.
• Full-time work authorization in the US (hirify.global does not provide sponsorship).
• Ability to work onsite in a manufacturing environment in Houston, Texas.

Nice to have

• Previous experience in an orthopedic medical device manufacturing setting.
• Proficiency in DFM, Lean Manufacturing, Process Control, DOE, and 6 Sigma.
• Knowledge of FDA regulations (21CFR 820) and ISO 13485 standards.
• Experience with CAD software (SolidWorks, MasterCAM, AutoCad) and Minitab.
• Experience with Measurement Systems (CMMs, Vision Inspection) and GD&T (ASME Y14.5M).

Culture & Benefits

• Comprehensive medical, dental, and vision insurance.
• 401(k) plan and spending/savings accounts.
• Paid vacation, sick leave, and holidays.
• Income protection plans and discounted insurance rates.
• Legal services.