Manufacturing Validation Engineer

System One; Redmond (WA); On-site; USD 73,000 - 80,000; Full time

Benefits offered by this job

Medical

Dental

Vision

Spending accounts

Life insurance

Voluntary plans

Participation in a 401(k) plan

Job summary

System One, Inc. is seeking a Manufacturing Validation Engineer in Redmond, WA for a 9 month contract.

The role focuses on expanding production test capacity for the LP35 product line, validating new automated test stations, and supporting qualification protocols for a Class III life-sustaining medical device. You will lead validation activities, develop reports, and coordinate with cross-functional teams to ensure reliable test systems before shipping.

Qualifications

• Bachelor's degree required.
• Strong communication and cross-functional collaboration.
• Experience with validation projects is a plus.
• Willingness to troubleshoot with support from test engineers.

Responsibilities

• Oversee capacity expansion for LP35 production test stations and validation.
• Perform validation activities and report results.
• Support manufacturing operations and equipment qualification protocols.
• Coordinate with cross-functional teams to drive validation plans.
• Maintain documentation including IQ/PQ and validation reports.

Skills

Self-driven

Strong communication

Cross-functional teamwork

Troubleshooting

Education

Bachelor's degree

Job description

Job Title: Manufacturing Validation Engineer
Location: Redmond, Washington
Type: 9 month contract
Compensation: $53-58/hour, depending on qualifications
Work Model: On-Site

Overview
Lead expansion of production test capacity for the LP35 product line by validating new automated test stations, executing equipment qualification protocols, and supporting manufacturing operations for a Class III life-sustaining medical device.

Responsibilities

• Oversee production capacity expansion project for the LP35 product line, including assembly, characterization testing, troubleshooting, and formal validation of additional test stations for production, surrogate, and troubleshooting test.
• Performs engineering work in operations, production, or maintenance environments.
• Primarily a validation exercise
• There is a piece of standing test equipment – a device, once assembled, will be tested on that test equipment before getting shipped out. These are the manufacturer's test to ensure it's operational before it gets released.
• Procuring equipment and building several automated testation, replicate validations (PQ, IQ).
• Validation plans, reports, and completing replicate validations.
• Class 3 medical device, defibrillator, life save device.

Requirements

• Self-driven, strong communication skills and ability to work with cross functional teams
• Validation experience is a huge plus
• Not a huge technical lift, but some troubleshooting background would be beneficial; there are test engineers that are willing to help out if needed though
• Bachelor's degree

System One, and its subsidiaries including Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality.

Benefits

• Medical
• Dental
• Vision
• Spending accounts
• Life insurance
• Voluntary plans
• Participation in a 401(k) plan

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.