Product Engineer - Medical Devices & Design Transfer

OrganOx Limited; Alabama; Presencial; USD 80.000 - 110.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health insurance

Dental insurance

Vision insurance

Disability coverage

401(k)

Paid time off

Holidays

Wellness facility

Employee discounts

Professional development

Descripción de la vacante

OrganOx Limited seeks a Product Engineer to join the Product Engineering team. You will support design changes, verify features, and drive improvements for the current product range.

Collaboration with operations, quality, and service teams will be essential to resolve obsolescence, manufacturing issues, and field concerns. The role requires a background in engineering or sciences, experience in electro-mechanical devices, and strong documentation skills to meet ISO13485 standards.

Formación

• Bachelor's degree in Computer Science, Software Engineering, Biomedical Engineering, or related discipline.
• 5–7 years of experience in a similar role.
• Experience with regulated medical device environments (ISO 13485) and quality systems.
• Experience in debugging, design changes and documentation.

Responsabilidades

• Contributing to design changes to support product, production and quality improvements.
• Investigating device performance issues, determining root cause with cross-functional teams, and recommending corrective actions.
• Interpreting and understanding the product’s intended use, clinical procedures, customer needs and design inputs.
• Creating and refining engineering documentation, such as the Design History File and the Device Master Record.
• Following R&D procedures, such as failure analysis, design controls and risk management, per the Quality Management System.
• Assisting prototyping efforts and bench testing.
• Prepare reports and conclusions for presentation.
• Ensuring compliance with ISO 13485 and local procedures.

Conocimientos

Product engineering

Medical devices

Electro-mechanical design

Test plan design

Root cause analysis

Technical reporting

Cross-functional collaboration

Communication skills

Educación

Bachelor's degree in Computer Science, Software Engineering, Biomedical Engineering, or related

Descripción del empleo

OrganOx Limited seeks a Product Engineer to join the Product Engineering team. You will support design changes, verify features, and drive improvements for the current product range.

Collaboration with operations, quality, and service teams will be essential to resolve obsolescence, manufacturing issues, and field concerns. The role requires a background in engineering or sciences, experience in electro-mechanical devices, and strong documentation skills to meet ISO13485 standards.