Senior Design Quality Engineer - Medical Devices

B. Braun Medical Inc.; Goleta (CA); Sur place; USD 150 000 - 190 000; Plein temps

Résumé du poste

B. Braun Medical Inc. in Goleta, CA is seeking a Staff Quality Engineer focused on design quality to support development and lifecycle management of surgical medical devices. You will lead design controls, risk management, validation, and DHF documentation while guiding CAPA and supplier quality activities.

The role collaborates with R&D, Manufacturing, Regulatory Affairs, and audits to ensure compliance with FDA/ISO standards and drives continuous improvement across the quality system.

Qualifications

• Bachelor's degree in Biomedical, Mechanical, Electrical, or Industrial Engineering (or equivalent).
• 8+ years of Design Quality Engineering experience in medical devices.
• Deep understanding of design controls and risk management (21 CFR Part 820, ISO 13485).
• Experience with FDA/ISO regulatory compliance for exoscope-robotic medical devices.
• Strong analytical, problem-solving, and communication skills.

Responsabilités

• Review design control activities, design reviews, risk management, and usability engineering.
• Provide quality engineering support for hardware, software, BME, and CSV validation activities.
• Maintain DHF documentation and ensure regulatory compliance.
• Lead CAPA investigations and verify effectiveness of corrective actions.
• Review complaint investigations, risk analysis, and supplier quality activities.
• Collaborate with R&D, Manufacturing, Regulatory Affairs, and Marketing to meet quality objectives.
• Participate in internal and external audits and develop quality plans and procedures.

Connaissances

Quality engineering

Design controls

Risk management

Regulatory compliance

FDA/ISO knowledge

Analytical/problem solving

Communication skills

Cross-functional collaboration

Formation

Bachelor's degree in Engineering

Master’s degree in Engineering

ASQ CQE/CQA certification

ISO 13485 knowledge

Description du poste

B. Braun Medical Inc. in Goleta, CA is seeking a Staff Quality Engineer focused on design quality to support development and lifecycle management of surgical medical devices. You will lead design controls, risk management, validation, and DHF documentation while guiding CAPA and supplier quality activities.

The role collaborates with R&D, Manufacturing, Regulatory Affairs, and audits to ensure compliance with FDA/ISO standards and drives continuous improvement across the quality system.