Quality Engineer

Katalyst CRO; New Kensington (Westmoreland County); On-site; USD 90,000 - 130,000; Full time

Job summary

Katalyst CRO seeks a Senior Reliability/Quality Engineer to drive reliability planning, establish analyses, and ensure medical devices meet requirements. You will lead failure analyses, CAPA efforts, and work with engineering to enhance product robustness.

Responsibilities include Weibull analysis, accelerated testing, and rigorous design verification while aligning with regulatory standards and manufacturing improvements. Strong Six Sigma and CRE/ CQE skills are valued.

Qualifications

• B.S. in a technical field; Masters preferred.
• 6+ years in design quality, quality engineering, or reliability.
• Experience with medical device regulatory requirements (MDSAP ISO 13485/14971, IEC 62304, 60601).
• ASQ certifications (CQE, CRE, CMQ/OE) preferred.
• Certified Reliability Engineer and Six Sigma GB/BB preferred.

Responsibilities

• Work with product engineering to develop reliability requirements and plans.
• Lead root cause analyses and corrective actions for warranty and quality issues.
• Conduct FMEAs on new products and support manufacturing with new processes.
• Perform reliability testing, accelerated life/stress testing, and data analyses.
• Participate in training/workshops on quality and reliability engineering.

Skills

Statistical analysis

Root cause analysis

Quality improvement

Team collaboration

Training delivery

Education

Bachelor's degree in Electrical/Mechanical/Bioengineering/Software Engineering

Master's degree preferred

Job description

• 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

Roles & Responsibilities

• 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

Requirements

• 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