Lead Reliability Engineer

Flex•Austin, TX

About The Position

Flex is the diversified manufacturing partner of choice that helps market-leading brands design, build and deliver innovative products that improve the world. A career at Flex offers the opportunity to make a difference and invest in your growth in a respectful, inclusive, and collaborative environment. If you are excited about a role but don't meet every bullet point, we encourage you to apply and join us to create the extraordinary. Job Summary To support our extraordinary team who build great products and contribute to our growth, we’re looking to add a Lead Reliability Engineer located in Austin, Tx . Reporting to the Director, Operations Engineering the Lead Reliability Engineer ensures that manufacturing equipment operates at peak reliability and compliance. This role focuses on minimizing downtime, improving equipment performance, and supporting regulatory requirements to maintain product quality and patient safety.

Requirements

Education: Bachelor’s degree in mechanical, Electrical, Biomedical, or Industrial Engineering.
Experience: 3–5 years in equipment reliability or maintenance engineering (within a regulated industry medical devices, pharma, biotech preferred).
Skills: Strong knowledge of reliability tools (RCM, FMEA, RCA).
Familiarity with FDA regulations, ISO 13485, and GMP standards.
Proficiency in CMMS and reliability software.
Excellent analytical, documentation, and communication skills.

Nice To Haves

Certified Reliability Engineer (CRE)
Six Sigma Green/Black Belt
ASQ or Biomedical Equipment Technician (BMET) certifications

Responsibilities

Reliability & Compliance: Develop and implement reliability strategies aligned with FDA, ISO 13485, and GMP requirements. Ensure equipment qualification and validation activities meet regulatory standards.
Failure Analysis & Preventive Measures: Perform root cause analysis (RCA) for equipment failures and implement corrective actions. Design preventive and predictive maintenance programs using condition monitoring tools.
Performance Monitoring: Track equipment KPIs (MTBF, MTTR, OEE) and identify trends to improve reliability. Maintain accurate documentation for audits and regulatory inspections.
Continuous Improvement: Lead reliability projects to reduce downtime and improve throughput in cleanroom and controlled environments. Collaborate with Quality, Manufacturing, and Engineering teams to implement best practices.
Risk Management: Conduct Failure Modes and Effects Analysis (FMEA) for critical equipment. Support risk assessments for new equipment introduction and process changes.