Design Quality Engineer III — MedTech Impact & Compliance

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

Job summary

Becton Dickinson NA in San Diego, CA is seeking a Design Quality Engineer to support sustaining engineering for hardware medical devices. You will participate in design controls, risk management, and verification/validation activities, ensuring regulatory compliance and robust quality systems.

The role emphasizes CAPA investigations, post‑market assessments, and cross‑functional collaboration with R&D, Manufacturing, and Regulatory Affairs to sustain and improve product quality across the

Qualifications

• Bachelor's degree in Engineering (Biomedical, Mechanical, Electrical, Industrial, or related field).
• 3+ years of Design Quality Engineering experience in hardware-based medical devices or electromechanical products.
• Experience with hardware product development, design verification, validation, and design transfer activities.
• Strong knowledge of FDA QSR (21 CFR Part 820) and ISO 13485.
• Hands‑on experience with design controls and ISO 14971.
• Basic understanding of corrections/removals processes (21 CFR Part 806).
• Strong analytical and problem‑solving skills; ability to investigate complex issues.
• Effective written and verbal communication; able to work independently and in fast-paced teams.

Responsibilities

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

Skills

Design quality principles

Design controls

Risk management

FMEA

CAPA

VOE

FDA/ISO compliance

Audit readiness

Cross-functional collaboration

Mentoring

Education

Bachelor's degree in Engineering

Tools

Minitab

JMP

Job description

Becton Dickinson NA in San Diego, CA is seeking a Design Quality Engineer to support sustaining engineering for hardware medical devices. You will participate in design controls, risk management, and verification/validation activities, ensuring regulatory compliance and robust quality systems.

The role emphasizes CAPA investigations, post‑market assessments, and cross‑functional collaboration with R&D, Manufacturing, and Regulatory Affairs to sustain and improve product quality across the