Product Design Quality Engineer

Job Description

Product Design Quality Engineer

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Location: Bothell, WA | Hybrid

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Benefits: No employer-provided benefits are offered for this contract position.

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Job Summary

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We are seeking a Product Design Quality Engineer to support product development and lifecycle quality activities in a regulated environment. This role will focus on design quality, process validation, design controls, risk management, verification and validation, CAPA, root cause analysis, and continuous improvement. The ideal candidate will have strong quality engineering or related engineering experience and the ability to work effectively with cross-functional stakeholders.

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Responsibilities

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• Create and execute comprehensive process validation strategies using statistical tools to support the transition of new products into production while meeting quality and regulatory requirements.
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• Manage design control activities, including design inputs, verification, validation, and design transfer.
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• Develop and maintain quality engineering documentation, including quality plans for hardware, software, and systems.
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• Integrate quality, reliability, and Post Market Surveillance (PMS) insights throughout the product lifecycle to drive continuous improvement.
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• Assess product and system designs, review performance data, and conduct root cause analysis to identify and resolve quality issues.
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• Validate critical design inputs related to usability, reliability, performance, manufacturability, and safety.
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• Support risk management activities throughout the product lifecycle, including risk identification, assessment, and mitigation.
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• Analyze post-market performance data and provide actionable feedback to manufacturing and design teams.
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• Support preparation for quality audits and inspections by maintaining appropriate documentation and processes.
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• Manage and execute CAPA activities, including problem identification, root cause analysis, corrective actions, and prevention of recurrence.
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• Apply continuous improvement techniques to strengthen quality practices and maintain audit readiness.
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• Collaborate with internal and external stakeholders and provide guidance related to quality standards and project milestones.
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Required Qualifications

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• Bachelor's or Master's degree in Mechanical Engineering, Electronics Engineering, Science, or an equivalent field.
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• With a Bachelor's degree, 5+ years of experience in Quality Engineering, Safety Engineering, R&D Engineering, or an equivalent area.
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• A Master's degree may qualify candidates with no prior experience, as specified for the role.
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• Experience with quality engineering, design quality, or related product development quality activities.
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Preferred Qualifications

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• Six Sigma Green Belt certification.
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• Experience with Design Quality Management.
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• Data analysis and interpretation.
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• Design for Quality (DFQ).
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• Root Cause Analysis (RCA).
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• CAPA methodologies.
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• Regulatory requirements.
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• Privacy, safety, and security considerations.
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• Risk assessment.
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• Technical documentation.
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• Continuous improvement.
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• Product quality and reliability.
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• Defect management.
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• Design verification planning.
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• Design validation planning.
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• Product test design.
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Equal Opportunity Employer

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We are committed to providing equal employment opportunities to all qualified applicants and maintaining an inclusive workplace. Employment decisions are made without regard to legally protected characteristics under applicable federal, state, or local law.

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Application

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Qualified candidates are encouraged to apply and will be considered based on their skills, experience, and qualifications.