Manufacturing Engineer – Lean & Quality Systems

Fortive Careers; Everett (WA); On-site; USD 90,000 - 120,000; Full time

Job summary

Fluke Health Solutions in Everett, WA is seeking an Operations Engineer to partner with Design and Test Engineering to enhance device quality and lean processes. You will deliver clear work instructions for operators and support key projects from design to production in a regulated environment.

The role emphasizes problem solving, root-cause analysis, and cross-functional collaboration with R&D, Quality, and Supply Chain while applying Fortive Business System practices for continuous improvement

Qualifications

• Bachelor’s degree in Mechanical, Electrical, or Biomedical Engineering, Computer Science, or equivalent.
• 2+ years of related Engineering experience.
• Knowledge of manufacturing processes, calibration, and metrology in regulated environments.
• Ability to deliver root-cause analysis using problem-solving methodologies.
• Knowledge of ISO 13485 / FDA 21 CFR 820 quality systems preferred.
• Ability to open and interpret CAD drawings for design of parts, fixtures, and jigs.

Responsibilities

• Formulate and issue clear, concise process and procedure instructions for production operators.
• Analyze historical test data and non-conforming material; identify root causes and implement corrective actions.
• Coordinate with R&D, Operations, Quality, and Supply Chain to maintain robust manufacturing systems.
• Use lean manufacturing to improve layout, tooling, fixtures, and process flow.
• Complete design changes with collaboration from Device Engineering and RA/QA.
• Investigate customer returns to resolve root cause and implement countermeasures.
• Apply Fortive Business System; participate in Kaizen.
• Ensure conformance to ISO 13485 / FDA 21 CFR 820 quality system.

Skills

Root-cause analysis

Problem solving

Data-driven decisions

Collaboration

Bias to action

Attention to detail

Education

Bachelor’s degree in Mechanical, Electrical, or Biomedical Engineering, Computer Science, or equivalent

Tools

CAD software

Job description

Fluke Health Solutions in Everett, WA is seeking an Operations Engineer to partner with Design and Test Engineering to enhance device quality and lean processes. You will deliver clear work instructions for operators and support key projects from design to production in a regulated environment.

The role emphasizes problem solving, root-cause analysis, and cross-functional collaboration with R&D, Quality, and Supply Chain while applying Fortive Business System practices for continuous improvement