Quality Engineer

A Quality Engineer is responsible for ensuring product quality, reliability, and regulatory compliance throughout the product development lifecycle. This role develops and executes reliability plans, conducts Design FMEA, risk assessments, statistical analyses, and accelerated life testing (HALT/HAST), while supporting root cause investigations and CAPA activities.

• B.S. in a technical field, Electrical, Mechanical, Bioengineering, Software Engineering etc. Masters degree preferred.
• Electrical and software development experience is preferred
• Material science or plastics engineering experience is preferred
• Expertise with Design Quality, Reliability and Safety/Compliance is a must.
• ASQ certifications (CQE, CRE, CMQ/OE etc) Preferred.
• Strong understanding of medical device industry regulatory requirements including but not limited to MDSAP participating countries, ISO Standards (ISO 13485 and ISO 14971), EUMDR, IEC 62304, IEC 60601, IEC 62366.
• Certified Reliability Engineer - Preferred
• Six Sigma GB/BB - Preferred
• 6+ years of experience in design quality, quality engineering, or reliability
• Work with product engineering to develop reliability requirements, establish a reliability plan and perform appropriate analyses to ensure that new products meet all of the requirements.
• Work with the project teams to develop a reliability plan to document tasks, methods, tools, tests and analyses that are required for the success of new products.
• Assist engineering teams to achieve warranty reduction and improve customer satisfaction by leading quality efforts on problem identification, failure root cause analysis, corrective action development and resolution verification.
• May participate and/or conduct training and workshops on quality and reliability engineering, robustness, and statistics as necessary within product engineering.
• Participate in product design and reliability reviews during new product development to ensure robustness of product design and manufacturing processes.
• Perform statistical data analysis, regression modeling, Weibull Analysis, hazard analysis, reliability growth assessment and prediction, target setting, warranty trend analysis and spending forecast for new products.
• Perform Design FMEAs on all new products and recommend design changes to improve product reliability.
• Work with Manufacturing to evaluate and qualify new technology and new processes implemented in manufacturing.
• Conduct reliability testing on new and existing products. Highly Accelerated Life Testing and Highly Accelerated Stress Testing to identify product failure modes. Validate and track product requirements through development.
• Conduct accelerated life testing on both the component and system level to provide feedback on design life which can be used to evaluate failure and safety risks within the project.
• Certified Reliability Engineer - Preferred
• Six Sigma GB/BB - Preferred