Lead Systems Design & Quality Engineer

Elyon International; Bothell (WA); On-site; USD 110,000 - 140,000; Full time

Benefits offered by this job

Paid sick leave

Medical/Dental (optional)

401(k) Retirement Plan (optional)

Employer Paid Life Insurance

Employer Paid Short Term Disability

Optional Life Insurance

Job summary

ELYON International, Inc. is a quality-focused engineering leader seeking a candidate to drive design verification, validation, and transfer across hardware, software, and systems.

You will lead risk assessments, CAPA, and continuous improvement initiatives while ensuring regulatory and quality compliance throughout the product lifecycle. Responsibilities include drafting and maintaining quality plans, performing root-cause analysis, and guiding cross-functional teams through audits and

Qualifications

• Bachelor's or Master's degree in engineering or science as stated.
• Minimum 5+ years experience in Quality Engineering, Safety Engineering, R&D Engineering, or equivalent, or a Master's with no experience.
• Certification not required, but Six Sigma Green Belt preferred.

Responsibilities

• Create and execute process validation strategies using statistical tools.
• Lead design control, from inputs to verification, validation, and design transfer.
• Draft and maintain quality documents for hardware, software, and systems.
• Drive quality improvement through PMS insights and lifecycle integration.
• Perform design reviews, root cause analysis, and CAPA implementation.
• Validate usability, reliability, performance, manufacturability, and safety.
• Guide risk management across product lifecycle and ensure mitigation.
• Use post-market data to drive corrective actions with manufacturing/design teams.
• Prepare for quality audits and inspections with proper documentation.
• Record and manage CAPA processes and ongoing improvements.
• Apply continuous improvement techniques and maintain audit readiness.
• Engage with internal and external stakeholders to align with standards and milestones.

Skills

Data Analysis

Root Cause Analysis

CAPA

Design for Quality

Regulatory Requirements

Risk Assessment

Technical Documentation

Continuous Improvement

Product Quality and Reliability

Defect Management

Design Verification Planning

Design Validation Planning

Product Test Design

Six Sigma Green Belt

Education

Bachelor's / Master's Degree in Mechanical Engineering, Electronics Engineering, Science, or equivalent

Job description

ELYON International, Inc. is a quality-focused engineering leader seeking a candidate to drive design verification, validation, and transfer across hardware, software, and systems.

You will lead risk assessments, CAPA, and continuous improvement initiatives while ensuring regulatory and quality compliance throughout the product lifecycle. Responsibilities include drafting and maintaining quality plans, performing root-cause analysis, and guiding cross-functional teams through audits and