Quality Engineer

Creative Solutions Services, LLC; New Kensington (Westmoreland County); On-site; USD 95,000 - 135,000; Full time

Job summary

Creative Solutions Services, LLC seeks a qualified Reliability Engineer to collaborate with product engineering to define reliability requirements and plans for new devices. You will lead analyses to ensure products meet performance targets and participate in design reviews.

Responsibilities include design FMEAs, accelerated testing, data analysis (Weibull, regression), and supporting manufacturing with new processes, while driving warranty reduction and regulatory compliance.

Qualifications

• B.S. in a technical field; Masters preferred.
• Electrical and software development experience preferred
• Material science or plastics engineering experience preferred
• Expertise with Design Quality, Reliability and Safety/Compliance
• ASQ certifications preferred
• Strong understanding of medical device regulatory requirements including MDSAP, ISO 13485, 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

Responsibilities

• Develop reliability requirements and plans for new products in collaboration with product engineering.
• Work with project teams to document tasks, methods, tools, tests and analyses needed for success.
• Lead quality efforts to reduce warranty and improve customer satisfaction through problem identification and corrective action.
• May conduct training/workshops on quality and reliability engineering and statistics.
• Participate in design and reliability reviews to ensure robust product design and manufacturing processes.
• Perform statistical data analysis, regression, Weibull analysis, hazard analysis, and reliability growth assessment.
• Perform Design FMEAs and recommend design changes to improve reliability.
• Coordinate with Manufacturing to evaluate and qualify new technologies and processes.
• Conduct reliability testing (HALT/HASS) to identify failure modes and validate requirements.
• Provide feedback on design life and safety risks across projects.

Skills

Reliability engineering

Design Quality

Six Sigma

Regulatory compliance

Statistical analysis

Education

B.S. in a technical field

Masters degree preferred

ASQ certifications

Tools

FMEA

Weibull analysis

Job description

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