Medical Device Manufacturing Validation Engineer (On-Site)

System One, Inc.; Redmond; On-site; AUD 104,000 - 114,000; Full time

Job summary

System One, Inc. is seeking a Manufacturing Validation Engineer in Redmond, WA to lead the expansion of production test capacity for the LP35 product line.

You will validate new automated test stations, execute equipment qualification protocols, and support manufacturing operations for a Class III life-sustaining medical device. The role emphasizes hands-on validation, IQ/PQ activities, and collaboration with cross-functional teams.

Qualifications

• Self-driven with strong communication and cross-functional collaboration.
• Validation experience is a huge plus.
• Some troubleshooting ability; help from test engineers.
• Bachelor’s degree required.

Responsibilities

• Oversee expansion of LP35 test stations and validate production tests.
• Perform engineering work in operations, production, or maintenance.
• Lead validation activities including IQ/PQ.
• Ensure test equipment validates prior to release.
• Prepare validation plans and reports; replicate validations.
• Support Class III life-sustaining device manufacturing.

Skills

Self-driven

Communication

Cross-functional teams

Validation experience

Troubleshooting

Education

Bachelor’s degree

Job description

System One, Inc. is seeking a Manufacturing Validation Engineer in Redmond, WA to lead the expansion of production test capacity for the LP35 product line.

You will validate new automated test stations, execute equipment qualification protocols, and support manufacturing operations for a Class III life-sustaining medical device. The role emphasizes hands-on validation, IQ/PQ activities, and collaboration with cross-functional teams.