Reliability & Quality Engineer - Medical Devices

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

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.