Reliability Engineer – Medical Devices

Company: A leading organization in innovative healthcare solutions, specializing in medical device technologies. They are committed to ensuring the highest standards of product safety and reliability through advanced engineering and rigorous testing processes.

Job Description:

We are seeking a skilled Reliability Engineer to join our client’s team. In this role, you'll manage reliability programs for medical devices, working independently and cross-functionally to ensure products meet quality and safety standards from development through manufacturing.

Responsibilities:

Implement and oversee reliability strategies (RAMS) for supported products.

Develop and execute testing plans such as life testing, ALT, HALT, HASS, Durability, and more to validate product robustness.

Document all work in accordance with Good Documentation Practices, following the Quality Management System.

Collaborate with teams including Patient Safety and Quality to continually improve the reliability processes, ensuring product safety and performance.

Support engineering teams in reducing warranty issues and increasing customer satisfaction through root cause analysis and corrective actions.

Participate in design and reliability reviews during product development, ensuring robustness in design and manufacturing processes.

Perform statistical analysis (regression, Weibull, Monte Carlo, hazard analysis, etc.) to predict reliability and set targets.

Conduct Design FMEAs on new products, recommending improvements for increased reliability.

Apply Design for Reliability and Six Sigma principles to product development initiatives.

Work with Manufacturing to evaluate and qualify new technologies and processes.

Assist in planning schedules and estimating efforts for project activities.

Provide technical feedback to improve product and service quality.

Requirements:

Bachelor's or Master's degree in Electrical, Mechanical, Biomedical, Industrial Engineering, or Computer Science.

At least 2 years of experience in reliability testing, reliability program development, or related fields, or relevant Master’s degree with no prior experience.

Knowledge of reliability analysis techniques, hardware testing, and software quality is advantageous.

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