Manufacturing Validation Engineer

System One; 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

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. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as 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.

#LI- Ref: #558-Scientific

Ref: #558-Scientific

System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as 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.