Senior Design Quality Engineer — Medical Devices

Regulatory Jobs; San Diego (CA); Presencial; USD 106.000 - 169.000; Jornada completa

Descripción de la vacante

BD in San Diego is seeking a Quality core team member for sustaining engineering projects in a fast-paced medical device environment. You will participate in design control activities, risk management, and verification/validation planning to ensure compliance with FDA and ISO 13485.

Join a cross-functional team and mentor junior engineers while developing quality plans, improving processes, and supporting internal/external audits to maintain robust quality systems and patient safety.

Formación

• 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

Responsabilidades

• 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 performing investigations and implementation of actions, and executing verification of effectiveness to ensure solutions are sustained and compliant with FDA/ISO and internal requirements.
• 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, identifying opportunities for process optimization.

Conocimientos

Design Quality Engineering

Regulatory knowledge (FDA 21 CFR Part

Risk management (ISO14971)

Design controls

ASQ CQE certification

Educación

Bachelor’s degree in Engineering

Herramientas

Minitab

JMP

Descripción del empleo

BD in San Diego is seeking a Quality core team member for sustaining engineering projects in a fast-paced medical device environment. You will participate in design control activities, risk management, and verification/validation planning to ensure compliance with FDA and ISO 13485.

Join a cross-functional team and mentor junior engineers while developing quality plans, improving processes, and supporting internal/external audits to maintain robust quality systems and patient safety.