Reliability Engineer

Azzur Group is seeking a highly skilled and experienced Reliability Engineer to join our team. The ideal candidate will be responsible for ensuring the reliability of products through comprehensive reliability activities such as development, design, testing, analysis, product, and quality assurance. The engineer will work within established quality systems, adhering to documented procedures, quality standards, and regulatory requirements.

Key Responsibilities:

• Develop operating procedures and guidelines to establish best practices for future products and components.
• Assess existing field data and test lab capabilities, identifying gaps and expanding capabilities to ensure future products are robust and reliable.
• Achieve competency in this role within 90 days following training.
• Conduct post-market surveillance, evaluate and assess field data, and perform real-time aging of products.
• Track product reliability against predictions, update models as necessary, and support complaint/failure investigations.
• Lead corrective and preventive actions within the quality management system. Address component obsolescence by identifying replacement components and leading the qualification of these components.
• Collaborate closely with design engineering to make recommendations and improve product reliability through design (e.g., modeling, stress analysis, and implementation).
• Ensure all reliability deliverables outlined in the project plans are completed on schedule.
• Establish and drive reliability goals.
• Conduct reliability predictions and failure mode identification.
• Develop and execute Highly Accelerated Life Tests (HALT) and environmental stress screening programs.
• Work with component suppliers to ensure components are qualified to operate reliably in their intended use environment for their expected service life.

Requirements

• Bachelor’s degree in Engineering, Computer Science, Mathematics, or a related field.
• Minimum of 10 years of electrical and reliability engineering experience with a focus on electro-mechanical assemblies.
• Extensive experience in reliability predictions and testing, including life testing, High-Temperature Operating Life (HTOL), Highly Accelerated Life Testing (HALT), and Mean Time to Failure (MTTF) predictions (using MIL-HDBK-217F or other prediction methods).
• Proven experience in the medical device industry, with a strong understanding of the physics of failure modes and their mitigation.
• Ability to develop qualification plans and protocols for individual components and commercial devices.
• Strong analytical and problem-solving skills. Excellent communication and collaboration abilities to work cross-functionally with engineering teams, suppliers, and stakeholders.
• Ability to drive and meet project deadlines in a fast-paced environment.

• Experience in a regulatory-compliant environment (e.g., FDA, ISO standards).
• Expertise in component qualification and obsolescence management.

Benefits

• Health Care Plan (Medical, Dental & Vision)
• Retirement Plan (401k, IRA)