Senior Design Quality Engineer - Medical Devices

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

Job summary

BD is a leading global medical technology company seeking a Design Quality Engineer to sustain engineering programs in a regulated environment. You will drive design control activities, risk management, and FDA/ISO 13485 compliance across DDFs and quality plans.

Responsibilities include CAPA investigations, VOE verification, post-market data analysis, and audits (FDA/Notified Body). You will mentor junior engineers and collaborate with cross-functional teams to sustain quality excellence.

Qualifications

• Bachelor’s degree in Engineering (Biomedical, Mechanical, Electrical, Industrial, or related field)
• 3+ years of Design Quality Engineering experience supporting hardware-based medical devices or electromechanical products
• Experience with hardware product development, design verification, validation, and design transfer activities
• Strong working knowledge of FDA Quality System Regulations (21 CFR Part 820) and ISO 13485
• Hands-on experience with design controls and risk management (ISO 14971)
• Basic understanding of corrections/removals processes (21 CFR Part 806)
• Strong analytical and problem-solving skills with the ability to investigate complex issues
• Effective written and verbal communication skills
• Ability to work both independently and collaboratively in a fast-paced environment

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 (e.g., FDA, ISO 13485).
• Perform and/or review risk management activities, including Hazard Analysis, FMEA, and risk-benefit analysis, ensuring appropriate risk mitigation strategies are identified and implemented.
• Provide quality engineering support for CAPA activities, including investigations and verification of effectiveness.
• 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 (e.g., FDA, Notified Body).
• Mentor junior quality engineers and provide technical guidance on design quality principles and practices.
• Collaborate with cross-functional teams (R&D, Manufacturing, Regulatory Affairs, Marketing) to ensure quality objectives are met.
• Develop and implement quality plans, procedures, and work instructions to enhance the effectiveness of the quality management system.
• Contribute to continuous improvement initiatives within the quality organization.

Skills

3+ years Design Quality Engineering

Strong analytical and problem-solving

Effective written and verbal comms

Independent and collaborative in fast‑

Education

Bachelor’s degree in Engineering

Master’s degree in Engineering

Tools

Minitab

JMP

Job description

BD is a leading global medical technology company seeking a Design Quality Engineer to sustain engineering programs in a regulated environment. You will drive design control activities, risk management, and FDA/ISO 13485 compliance across DDFs and quality plans.

Responsibilities include CAPA investigations, VOE verification, post-market data analysis, and audits (FDA/Notified Body). You will mentor junior engineers and collaborate with cross-functional teams to sustain quality excellence.