Quality Engineer

Katalyst CRO; New Kensington (Westmoreland County); On-site; USD 90,000 - 120,000; Full time

Job summary

Katalyst CRO in the United States is seeking a Senior Reliability Engineer to lead reliability, quality and safety activities for medical devices. You will develop reliability plans, run analyses and guide cross-functional teams to meet regulatory requirements.

You will perform Weibull and HALT/HASS testing, conduct FMEAs, and drive warranty reduction while mentoring engineers and participating in design reviews.

Qualifications

• B.S. in a technical field; Master’s preferred.
• Electrical and software development experience preferred.
• Materials science or plastics engineering experience preferred.
• Expertise in Design Quality, Reliability and Safety/Compliance required.
• ASQ certifications (CQE, CRE, CMQ/OE, etc.) preferred.
• Strong understanding of medical device regulatory requirements (ISO 13485, ISO 14971, EUMDR, IEC 62304, IEC 60601, IEC 62366).
• 6+ years in design quality, quality engineering, or reliability.

Responsibilities

• Develop reliability requirements and plans with product engineering.
• Document tasks, tools, tests and analyses for new products.
• Lead warranty reduction efforts and root-cause analysis.
• Possibly conduct trainings on quality and reliability within product engineering.
• Participate in design and reliability reviews during new product development.
• Perform statistical analyses, Weibull, hazard analysis and reliability forecasting.
• Conduct Design FMEAs and recommend design changes to improve reliability.
• Collaborate with Manufacturing to evaluate new technology and processes.
• Conduct reliability testing including HALT/HASS to identify failure modes.
• Validate and track product requirements through development.
• Perform accelerated life testing at component and system levels.
• Certified Reliability Engineer – Preferred; Six Sigma GB/BB – Preferred.

Skills

Reliability engineering

Weibull analysis

FMEA (Design)

Statistical analysis

HALT/HASS testing

Regulatory knowledge

Six Sigma

Cross-functional leadership

Education

B.S. in engineering or technical field

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