Senior Design Quality Engineer - Medical Devices

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

Job summary

BD in San Diego seeks a Design Quality Engineer to support sustaining engineering for hardware-based medical devices. You will engage in design control, risk management, verification and validation, and regulatory documentation.

You will mentor junior engineers and collaborate across R&D, Manufacturing, Regulatory Affairs and Marketing to ensure robust quality outcomes and continuous improvement in a fast-paced environment.

Qualifications

• Bachelor's degree in Engineering required.
• Experience with hardware-based medical devices or electromechanical products.
• Experience in design verification, validation and transfer.

Responsibilities

• Act as Quality core team member for sustaining engineering projects.
• Participate in design control activities including design reviews, risk management, verification and validation planning and execution.
• Support development and maintenance of design and development files (DDFs) to ensure regulatory compliance.
• Perform and review risk management activities including Hazard Analysis and FMEA with mitigations.
• Provide quality support for CAPA investigations and VOE to ensure sustained compliance.
• Author field issue assessments using post-market data, complaints, and risk analyses.
• Participate in internal and external audits (FDA, Notified Body).
• Mentor junior quality engineers and guide design quality practices.
• Collaborate with R&D, Manufacturing, Regulatory Affairs, Marketing to meet quality objectives.
• Develop and implement quality plans, procedures, and work instructions; drive process improvement.

Skills

Design Quality Engineering

Hardware product development

Design verification

Design validation

Risk management

FDA QSR 21 CFR 820 knowledge

ISO 13485 knowledge

ISO 14971

21 CFR Part 806 knowledge

Statistical tools

Education

Bachelor's degree in Engineering

Master's degree in Engineering

Tools

Minitab

JMP

Job description

BD in San Diego seeks a Design Quality Engineer to support sustaining engineering for hardware-based medical devices. You will engage in design control, risk management, verification and validation, and regulatory documentation.

You will mentor junior engineers and collaborate across R&D, Manufacturing, Regulatory Affairs and Marketing to ensure robust quality outcomes and continuous improvement in a fast-paced environment.