Senior Design Quality Engineer for Medical Devices

BD; San Diego (CA); On-site; USD 106,000 - 169,000; Full time

Benefits offered by this job

Medical benefits

401(k)

Job summary

BD is seeking a Quality Engineer to join the sustaining engineering team in San Diego. You will participate in design control activities, risk management, and V&V planning, ensuring regulatory compliance (FDA/ISO 13485).

You will support ongoing development files, CAPA actions, and post-market data analyses to sustain product quality. The role requires 3+ years in design quality engineering for hardware medical devices, strong analytical skills, and ability to collaborate across R&D,

Qualifications

• Bachelor's degree in Engineering or related field required.
• 3+ years in Design Quality Engineering for hardware-based medical devices or electromechanical products.
• Experience with hardware product development, design verification/validation, and design transfer.

Responsibilities

• Act as Quality core team member for sustaining engineering projects.
• Participate in design control activities, including design reviews, risk management, and V&V planning and execution.
• Support development and maintenance of design and development files (DDFs) to ensure compliance with internal procedures and external regulations (FDA, ISO 13485).
• Perform and review risk management activities (Hazard Analysis, FMEA) and ensure mitigation.
• Provide quality engineering support for CAPA investigations and VOE verification.
• Author field issue assessments using post-market data, complaints, and risk analyses (21 CFR 806, EU MDR).
• Participate in internal and external audits (FDA, Notified Body).
• Mentor junior quality engineers and provide technical guidance on design quality principles.
• Collaborate with R&D, Manufacturing, Regulatory, Marketing to meet quality objectives.
• Develop and implement quality plans, procedures, and work instructions.
• Identify opportunities for process improvement within the quality organization.

Skills

FDA 21 CFR Part 820

ISO 13485

Risk Management

Design Controls

Analytical Thinking

Communication

Team Collaboration

Education

Bachelor's degree in Engineering

Master's degree (preferred)

Tools

Minitab

JMP

Job description

BD is seeking a Quality Engineer to join the sustaining engineering team in San Diego. You will participate in design control activities, risk management, and V&V planning, ensuring regulatory compliance (FDA/ISO 13485).

You will support ongoing development files, CAPA actions, and post-market data analyses to sustain product quality. The role requires 3+ years in design quality engineering for hardware medical devices, strong analytical skills, and ability to collaborate across R&D,