Manufacturing Engineer

Operations Engineering · Everett, Washington · Full-time
Reports to: Engineering Manager 
Partners across: Engineering, Production, and Service (Repair & Calibration)

SECTION 1

Why should you join Fluke Health Solutions – Everett Ops

Everett Operations is intentionally transforming how engineering supports the factory – moving from reactive, daily firefighting to a preventive, capability-driven model. In this role, you will partner with Design and Test Engineering to improve device and component quality, improve lean manufacturing processes, and deliver on key projects from design to production. We are a team that values innovation, collaboration and growth and development.

SECTION 2

What this role entails:

• Formulate and issue clear, concise, and accurate, process and procedure instructions for the production operators.
• Analyze historical test data and non-conforming material, collaborate with suppliers and repair technicians to identify root cause of failures and implement permanent corrective actions - thereby improving performance quality.
• Coordinate closely with R&D, Operations, Quality, and Supply Chain teams to develop and maintain robust manufacturing systems capable of supporting world-class quality, delivery, and productivity performance.
• Use lean manufacturing principles to improve production layout, workstation concepts, tooling requirements, fixtures, work instructions, and manufacturing process flow – resulting in improved yield and waste reduction.
• Complete design changes for existing products with collaboration from Device Engineering and RA/QA, including First Article qualifications and associated design change documentation.
• Investigate customer returned units to resolve root cause of failure and work with design team to implement permanent countermeasures.
• Apply FBS Standard Work; participate in Kaizen.
• Ensure conformance to the ISO 13485 / FDA 21 CFR 820 quality system.

Fortive Business System Expectations

• Live the Fortive Business System: Kaizen, Standard Work, Problem Solving (root-cause to countermeasure), and Daily Management.
• Use visual management and data to drive decisions; sustain improvements rather than re-solve.
• Contribute to the function's continuous-improvement cadence and transactional/process Kaizen.

Job Leveling - Scope & Expectations

Knowledge & Expertise: Applies established engineering principles, standards, and procedures to defined problems. Brings a function depth of understanding in the manufacturing engineering discipline to drive growth and improvement in the factory.

Complexity & Problem-Solving: Solves problems of moderate scope using prescribed methods with minimal oversight. For problems with complex scope, proactively partners with senior engineers as needed.

Autonomy & Supervision: Works under general supervision; responsible for independently creating process and instructions for new work and projects.

Impact & Scope: Decisions affect factory floor manufacturability but have cross-functional ties to Design and Quality/Regulatory.

Influence & Interaction: Interacts primarily within the team and assigned cell; explains information to peers and technicians.

Adjacent levels: Growth path to DFX Manufacturing Engineer (P17/P18) as understanding of design, problem solving complexity, and project ownership increase.

SECTION 3

Required Qualifications

• Bachelor’s degree in Mechanical, Electrical, or Biomedical Engineering, Computer Science, or equivalent
• 2+ years of related Engineering experience
• Good knowledge of various manufacturing processes, calibration,[HH1]  and metrology preferably from an industry with high regulatory demands.
• Ability to deliver root-cause analysis using various problem-solving methodologies
• Knowledge of ISO 13485 / FDA 21 CFR 820 quality systems preferred
• Ability to open and interpret CAD drawings for design of new parts, fixtures, and jigs to facilitate ease of manufacturing and assembly. 

Fortive Leadership Behaviors & Anchors

• We deliver results - accountable to commitments and KPIs.
• We continuously improve - FBS as the way we work.
• We lead with intelligent action - bias to action, grounded in data.
• We build extraordinary teams - develop talent and inclusion.
• We learn and teach to win - curiosity over judgment; share knowledge.

Work Environment, Travel & Regulatory

• Work environment: manufacturing, test/calibration lab, and office areas at FHS Everett.
• Physical: prolonged computer use; occasional lifting/handling of instruments and fixtures (typically up to ~25 lbs); lab bench work.
• Travel: Minimal (< 5%).
• Regulatory & Quality: all activities conform to the FHS ISO 13485 / FDA 21 CFR 820 quality management system and applicable EHS requirements.
• Equal Opportunity: Fluke Health Solutions, a Fortive operating company, is an Equal Opportunity Employer.