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Jobs / Medical Device Quality Engineer in United States of America
18 hours agoBe an early applicant
Daikinapplied·18 hours ago
18 hours agoBe an early applicant

Design Quality Engineer

Plymouth, United States of AmericaMid · 2-5 years

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About this role

Join the world's largest HVAC company, named by Forbes as one of America's Best-In-State Employers 2025!

Design Quality Engineer – Plymouth, MN - Hybrid

Daikin Applied is seeking a Design Quality Engineer responsible for ensuring product quality is designed, validated, and verified throughout the product development lifecycle by owning requirements quality, design risk identification, and validation effectiveness to support evidence-based readiness decisions prior to product launch. This role is embedded within engineering teams and acts as a technical partner to ensure risks are understood, mitigated, and clearly articulated before advancing through NPI decision points.

Come be a part of an exciting journey at Daikin Applied, where innovation and excellence drive our every endeavor!

Location: Hybrid - Plymouth, MN

Your Responsibilities:

  • Requirements Quality
    • Ensure product and system requirements are complete, testable, and traceable from customer needs through engineering
    • Establish and maintain linkage between requirements, design outputs, and validation plans
    • Identify gaps, ambiguity, or misalignment early in the design process
    • Support integration of field, reliability, and validation feedback into requirements
  • Design Risk Management
    • Lead development and continuous improvement of DFMEA to ensure comprehensive risk identification and mitigation
    • Drive prioritization and closure of critical design risks prior to design freeze
    • Challenge assumptions, failure modes, and design trade-offs to improve robustness
    • Ensure design risks are transparent, quantified, and actively managed
  • Validation Effectiveness (Prove It Works)
    • Define and assess validation strategy and DVP&R to ensure coverage of critical requirements and risks
    • Evaluate validation results to confirm product performance, reliability, and safety
    • Ensure validation reflects real-world use conditions, not only lab compliance
    • Drive closure of validation gaps prior to key readiness and decision points
  • Design Readiness & Decision Support
    • Provide objective, evidence-based input into readiness reviews and decision points
    • Ensure readiness assessments reflect actual product maturity and residual risk
    • Support clear articulation of risk acceptance decisions and trade-offs
    • Drive consistency in how “ready” is defined across program
  • Manufacturing Readiness Alignment
    • Ensure alignment between design intent and production capability
    • Support transition of design outputs into manufacturing controls and process definitions
    • Identify and mitigate risks associated with design transfer to production
    • Ensure learning from manufacturing and field issues feeds back into design
  • Cross-Functional Design Collaboration
    • Embed within engineering teams to influence design decisions from concept through launch
    • Partner with Product Management, Engineering, Operations, and Quality functions
    • Act as the voice of product quality within development—not as a downstream reviewer
    • Facilitate structured, risk-based discussions across functions
  • Metrics & Continuous Improvement
    • Define and track leading indicators tied to:
      • Requirements quality
      • Design risk identification and closure
      • Validation coverage and effectiveness
      • Readiness risk at decision points
  • Use data to proactively identify trends and drive early corrective actions
  • Ensure learnings from issues and CAPAs are reflected in future design practices

Your Qualifications:

  • Bachelor’ s Degree in Engineering, or a related technical discipline
  • 6+ years in product development, design engineering, or quality engineering roles
  • Demonstrated experience working within product development or NPI environments
  • Design & Risk Expertise
    • Strong working knowledge of DFMEA and product risk analysis
    • Understanding of system-level design, interfaces, and failure mechanisms
    • Ability to identify and prioritize risks early in development
  • Requirements & Systems Thinking
    • Experience with requirements definition, traceability, and verification
    • Ability to assess requirements for clarity, completeness, and testability
  • Validation & Verification
    • Knowledge of validation planning and DVP&R development
    • Ability to assess test coverage relative to requirements and risks
    • Ability to interpret validation data and support decision making
  • Engineering Influence
    • Ability to challenge assumptions and influence design decisions
    • Strong facilitation skills for cross-functional technical discussions
    • Ability to operate as a peer within engineering teams
  • Analytical & Problem Solving
    • Strong analytical mindset with ability to evaluate data and identify patterns
    • Experience applying structured problem-solving methods
    • Ability to translate analysis into actionable design improvements

Your Benefits:

Daikin Applied offers the following benefits for this position, subject to applicable eligibility requirements: 

  • Multiple medical insurance plan options + dental and vision insurance  
  • 401K retirement plan with employer match
  • Paid time off and company paid holidays
  • Paid sick time in accordance with the federal, state and local law
  • Tuition Reimbursement after 6 months of continuous service 

Work visa sponsorship is not available for this position

The typical annual base salary for this position ranges from $109,100 - $188,700 plus a 15% bonus in Minnesota.  The range displayed represents the pay range for all positions in the job grade which these positions fall. Individual base pay will depend on a wide range of factors including your skills, qualifications, experience, and location.

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If you're looking for an engaging career with growth opportunities in a supportive environment, you'll love a career at Daikin Applied!

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