Senior Design Quality Engineer, Medical Devices

B. Braun; Goleta (CA); On-site; USD 150,000 - 190,000; Full time

Benefits offered by this job

Healthcare benefits

401(k) plan

Tuition reimbursement

Job summary

B. Braun is seeking a Staff Quality Engineer in Goleta, CA to lead design quality efforts for surgical medical devices. You will guide design controls, risk management, validation and DHF activities while supporting CAPA, supplier quality and audits.

The role emphasizes collaboration with R&D, Manufacturing, Regulatory Affairs and Marketing to ensure quality objectives are met, with a strong focus on FDA/ISO compliance and production-related quality needs.

Qualifications

• Bachelor's degree in Biomedical, Mechanical, Electrical, or Industrial Engineering.
• 8+ years of experience in Design Quality Engineering within the medical device industry.
• Deep understanding of design control requirements (QMSR 21 CFR Part 820, ISO 13485, ISO 14971).
• Strong analytical and problem-solving skills.
• Effective written and verbal communication; able to work independently and in teams.

Responsibilities

• Review design control activities (design reviews, risk management, requirements).
• Provide QA support for hardware, software, validation, and HV/CSV activities.
• Maintain DHF and ensure regulatory compliance (FDA, ISO 13485).
• Lead CAPA investigations and verify effectiveness.
• Collaborate with cross-functional teams (R&D, Manufacturing, Regulatory Affairs).
• Support audits (Internal/Notified Body) and continuous quality improvement.

Skills

Design quality engineering

Regulatory compliance

Analytical skills

Communication

Education

Bachelor's degree in Engineering

Master’s degree in Engineering (Desirable)

Job description

B. Braun is seeking a Staff Quality Engineer in Goleta, CA to lead design quality efforts for surgical medical devices. You will guide design controls, risk management, validation and DHF activities while supporting CAPA, supplier quality and audits.

The role emphasizes collaboration with R&D, Manufacturing, Regulatory Affairs and Marketing to ensure quality objectives are met, with a strong focus on FDA/ISO compliance and production-related quality needs.