Senior Reliability & Quality Engineer for Medical Devices

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

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.