Role: Staff Reliability Engineer Hardware
Experience: Minimum 6+ Years
Location: San Jose, CA
Work Mode: Onsite 5 Days a Week
We are looking for an experienced Staff Reliability Engineer to support product reliability, verification, validation, and design improvements for medical devices. The role involves developing and executing reliability test strategies, supporting new product development, and ensuring compliance with quality and regulatory standards.
Responsibilities
Develop and execute reliability test strategies for new product development.
Perform product characterization, verification, validation, environmental, transportation, life cycle, and stress testing.
Develop and maintain automated test scripts using LabVIEW, Python, or similar technologies.
Collaborate with engineering teams to improve product reliability, robustness, and design quality.
Support reliability assessments, statistical analysis, simulation, and engineering evaluations.
Coordinate with internal and external laboratories to execute testing activities.
Review product designs and recommend improvements based on Design for Reliability principles.
Prepare verification, validation, and reliability documentation in accordance with quality standards.
Support design control activities, corrective actions, and issue resolution during product development.
Maintain laboratory equipment, calibration records, and testing processes while ensuring compliance with quality and safety standards.
Support compliance with GMP, Quality Management System requirements, and Health and Safety procedures.
Required Skills
Minimum 6+ years of experience in Reliability Engineering or Product Validation.
Bachelor's or Master's degree in Mechanical Engineering, Electrical Engineering, Biomedical Engineering, or a related field.
Experience supporting new product development and reliability engineering activities.
Strong understanding of mechanical, electrical, or optical design principles.
Experience with reliability testing, environmental testing, transportation testing, life testing, and verification and validation.
Knowledge of statistical analysis and Design for Reliability methodologies.
Experience with LabVIEW, Python, or similar automation tools.
Knowledge of embedded systems, CAN Bus, Ethernet, and communication protocols.
Experience with laboratory testing, equipment validation, robotics, or test fixtures.
Knowledge of GMP, FDA Quality System Regulations, and Medical Device quality standards.
Strong analytical, troubleshooting, documentation, and communication skills.
Preferred Skills
Experience working in the Medical Device industry.
Knowledge of reliability simulation, tolerance analysis, and measurement science.
Experience supporting quality systems, design controls, and regulatory compliance.
Ability to work effectively with cross-functional engineering teams.
Education
Bachelor's or Master's degree in Mechanical Engineering, Electrical Engineering, Biomedical Engineering, or a related technical field. Relevant technical certifications are an added advantage.
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