Quality Engineer

About the Role

Collaborate with product engineering to define reliability requirements, establish comprehensive reliability plans, and perform analyses to ensure new products meet all specified standards. Develop and document reliability plans outlining tasks, methods, tools, tests, and analyses critical for product success. Lead quality initiatives to reduce warranty claims, improve customer satisfaction, and resolve issues through root cause analysis, corrective actions, and verification.

Responsibilities

• Develop reliability requirements and plans in partnership with product engineering teams.
• Create and maintain reliability plans documenting tasks, methods, tools, tests, and analyses for new products.
• Drive quality efforts to identify problems, perform root cause analysis, develop corrective actions, and verify resolutions to reduce warranty issues and enhance customer satisfaction.
• Conduct or participate in training and workshops on quality and reliability engineering, robustness, and statistics for product engineering teams.
• Participate in product design and reliability reviews to ensure robustness of designs and manufacturing processes.
• Perform statistical data analysis, including regression modeling, Weibull Analysis, hazard analysis, reliability growth assessment, target setting, warranty trend analysis, and spending forecasts.
• Conduct Design Failure Mode and Effects Analysis (FMEA) on new products and recommend design improvements to enhance reliability.
• Collaborate with manufacturing teams to evaluate and qualify new technologies and processes.
• Execute reliability testing on new and existing products, including Highly Accelerated Life Testing (HALT) and Highly Accelerated Stress Testing (HAST) to identify failure modes.
• Validate and track product requirements throughout the development lifecycle.
• Perform accelerated life testing at component and system levels to assess design life, evaluate failure risks, and ensure safety.

Requirements

• Bachelor’s degree in a technical field (e.g., Electrical, Mechanical, Bioengineering, Software Engineering); Master’s degree preferred.
• Electrical and software development experience is preferred.
• Experience with material science or plastics engineering is preferred.
• Expertise in Design Quality, Reliability, and Safety/Compliance is required.
• Strong understanding of medical device industry regulatory requirements, including MDSAP, ISO Standards (ISO 13485, ISO 14971), EUMDR, IEC 62304, IEC 60601, and IEC 62366.
• 6+ years of experience in design quality, quality engineering, or reliability.

Qualifications

• ASQ certifications (e.g., CQE, CRE, CMQ/OE) are preferred.
• Certified Reliability Engineer (CRE) certification is preferred.
• Six Sigma Green Belt or Black Belt (GB/BB) certification is preferred.