Manufacturing Engineer (Medical Devices)

TL;DR

Manufacturing Engineer (Medical Devices): Developing and optimizing manufacturing lines and processes for medical devices with an accent on production efficiency, quality, and regulatory compliance. Focus on troubleshooting production issues, implementing Lean Manufacturing principles, and managing new product introductions (NPI).

Location: Kennewick, WA

Salary: $79,000 - $100,000 USD

Company

hirify.global is a manufacturer of specialized medical devices.

What you will do

• Develop and improve manufacturing systems, equipment, and training for medical devices.
• Create and maintain production line test methods and fixtures to ensure repeatability and scalability.
• Troubleshoot production issues and implement corrective and preventive actions.
• Identify and justify capital equipment investments to improve production robustness.
• Ensure processes align with FDA 21 CFR Part 820, ISO 13485, and EU Medical Device Regulations.
• Partner with R&D, Quality, and Regulatory teams to facilitate smooth design transfers and NPI.

Requirements

• Bachelor’s degree in engineering or equivalent experience.
• 2+ years of professional engineering experience, preferably in the medical or a highly regulated industry.
• Working knowledge of Process Engineering, Optimization, and Design-for-Manufacture (DFM) concepts.
• Experience with the NPI lifecycle, from development through manufacturing validation.
• Knowledge of Continuous Improvement processes such as Lean Manufacturing, Six Sigma, Kaizen, or 5S.
• Must be based in or able to work on-site in Kennewick, WA.

Nice to have

• Familiarity with automation and smart manufacturing technology integration to reduce rework.

Culture & Benefits

• Equal Opportunity Employer focusing on diversity and inclusion.
• Hands-on ownership of manufacturing processes and systems.
• Collaborative environment working across R&D, IT, and Quality Assurance.