Manufacturing Engineer

Premier Group; Pasco (WA); On-site; USD 80,000 - 100,000; Full time

Job summary

Premier Group in Pasco, WA, is seeking a Manufacturing Engineer to own and improve production processes for high-quality medical devices. You will support NPI and design transfer, develop test methods and ensure regulatory alignment.

You will partner with Production, R&D, Quality, Regulatory and Supplier Quality to drive Lean initiatives, troubleshoot issues, and implement CAPAs while scaling operations for growth.

Qualifications

• Bachelor's degree in Engineering or equivalent.
• 2+ years of Manufacturing Engineering experience.
• Experience in a regulated medical devices environment.
• Knowledge of NPI and manufacturing transfer.
• Lean manufacturing and automation experience.

Responsibilities

• Developing, maintaining and improving manufacturing processes, equipment and production systems.
• Supporting New Product Introduction (NPI) and design transfer into manufacturing.
• Designing and improving production line test methods, fixtures and manufacturing processes.
• Troubleshooting production issues and implementing corrective and preventive actions.
• Identifying opportunities to improve efficiency, quality, throughput and manufacturing performance.
• Supporting capital equipment selection, justification and implementation.
• Developing and maintaining equipment calibration programs.
• Ensuring manufacturing processes comply with FDA, ISO 13485 and Medical Device Regulations.
• Supporting internal and external quality audits.
• Collaborating with Engineering, Production, Quality, Regulatory, Supplier Quality and IT teams.
• Driving Lean Manufacturing and continuous improvement initiatives across production.

Skills

Manufacturing processes

NPI

DFM

Lean Manufacturing

Automation

Root cause analysis

Cross-functional collaboration

Regulatory knowledge

Education

Bachelor's degree in Engineering

Job description

A leading medical device manufacturer is looking to add a Manufacturing Engineer to its growing engineering team in Pasco, Washington.

This is an excellent opportunity for an engineer who enjoys owning manufacturing processes, driving continuous improvement, and supporting new product introductions within a regulated manufacturing environment. You'll play a key role in ensuring production processes remain efficient, scalable and capable of delivering high-quality medical devices.

Working closely with Production, R&D, Quality, Regulatory and Supplier Quality teams, you'll help bridge engineering and manufacturing while contributing to the successful launch and ongoing support of new products.

The Role

As the Manufacturing Engineer, you'll be responsible for developing, maintaining and improving manufacturing processes, equipment and production systems while supporting day-to-day manufacturing operations.

Responsibilities include:

• Developing, maintaining and improving manufacturing processes, equipment and production systems
• Supporting New Product Introduction (NPI) and design transfer into manufacturing
• Designing and improving production line test methods, fixtures and manufacturing processes
• Troubleshooting production issues and implementing effective corrective and preventive actions
• Identifying opportunities to improve efficiency, quality, throughput and manufacturing performance
• Supporting capital equipment selection, justification and implementation
• Developing and maintaining equipment calibration programs
• Ensuring manufacturing processes comply with FDA, ISO 13485 and Medical Device Regulations
• Supporting internal and external quality audits
• Collaborating with Engineering, Production, Quality, Regulatory, Supplier Quality and IT teams
• Driving Lean Manufacturing and continuous improvement initiatives across production

What We're Looking For

• Bachelor's degree in Engineering or equivalent industry experience
• 2+ years' Manufacturing Engineering experience
• Experience working within a regulated manufacturing environment (medical devices preferred)
• Knowledge of New Product Introduction (NPI) and manufacturing transfer
• Experience developing manufacturing processes, production equipment or test methods
• Understanding of Design for Manufacturability (DFM)
• Strong troubleshooting and root cause analysis skills
• Excellent communication and cross-functional collaboration skills
• Medical Device Regulation (EU MDR)
• Lean Manufacturing
• Automation and manufacturing technology integration

What\'s On Offer

• Salary of $80,000-$100,000
• Opportunity to work within a well-established medical device manufacturer