Job Title: Design Quality Engineer
Position Summary
The Design Quality Engineer reports directly to the Engineering Department & works closely with our New Product Introduction team to review and assess product specifications, and to plan, develop, and execute inspection strategies throughout product development. The engineer works cross-functionally with Product Development, Project Management, & Manufacturing to ensure accurate and reliable testing. This position offers growth opportunities to either leverage or gain skills in CAD design, MSA, & GD&T.
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Key Responsibilities
Test Planning & Execution
• Provide input and aid in development of comprehensive test plans, protocols, and test methods to evaluate product performance, reliability, and compliance.
• Execute mechanical, electrical, functional, and environmental tests according to defined procedures.
• Analyze test data, document results, and generate formal test reports.
• Support verification and validation phases of new product development and sustaining engineering activities.
Measurement Expertise
• Lead Measurement System Analysis (MSA) activities including Gage R&R, bias, linearity, and stability studies.
• Develop and optimize measurement methods to ensure high accuracy, repeatability, and reproducibility.
• Support test method validation and measurement uncertainty analysis.
Quality & Compliance
• Ensure all testing activities comply with applicable standards, regulations, and QMS requirements (e.g., ISO 13485, customer specifications).
• Participate in risk assessments (e.g., DFMEA, PFMEA) to identify and reduce testing and measurement-related risks.
• Support nonconformance investigations by performing root cause analysis and contributing to corrective actions.
Cross-Functional Collaboration
• Work closely with Engineering, Quality, Manufacturing, and Supply Chain teams to communicate findings and provide technical support.
• Assist design teams with test input requirements, design for testability (DFT), and validation strategy.
• Review engineering drawings and specifications to ensure testability and measurable criteria.
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Qualifications
• Bachelor’s degree in Mechanical, Industrial, or a related engineering discipline.
• 3–7 years of experience in testing, validation, metrology, or quality engineering (Med-Device industry experience is preferred however, can be other highly regulated spaces like automotive, aerospace, etc.).
• Experience writing and executing test protocols, verification reports, and validation documentation.
• Hands-on experience with laboratory equipment, instrumentation, and calibration systems.
• Ability to interpret engineering drawings and specifications.
• Strong data analysis skills (e.g., Excel, Minitab, Python, or similar).
• Excellent communication, documentation, and organizational skills.
• Ability to communicate via email with English-based coworkers (Use of translation apps is permitted).
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Preferred Qualifications or Growth Opportunities
• Experience in a regulated environment (ISO 13485, GMP, IATF 16949, or equivalent).
• Strong proficiency with MSA methodologies, statistics, and measurement techniques.
• Expertise in Geometric Tolerancing (GD&T).
• CAD or Mechanical Design skills to conceptualize and create fixturing to aid in accurate measurement taking.
• Familiarity with root cause analysis tools (5 Why, 8D, Fishbone, Fault Tree).
• Experience with environmental, mechanical fatigue, or life-cycle testing.
• Knowledge of automated test systems or data acquisition platforms.
• Verbal English skills or willingness to grow in this area.
3083 5055-4|178 1185 4605 81• Experience with Electrical Test equipment such as DVM, LCR, circuit analysis testers, etc