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# Design Quality Engineer III

- **Company:** BD & BD, Inc.
- **Location:** San Diego, CA, United States
- **Experience:** Experienced
- **Salary:** $105,500.0 - $168,800.0
- **Contract:** Permanent contract
- **Skills:** Adobe InDesign, Failure Mode Effects Analysis, Minitab, Verification and Validation (Software), JMP (Statistical Software), Statistics Packages
- **Published:** October 26, 2026
- **Apply:** https://www.beyondsandiego.com/job.asp?id=3467538670&tx=TT434THZ&pt=1&aff=0B19D771-A501-4A5E-8338-2A822B784D54&utm_source=Job%20Feed&utm_medium=textkernel&utm_campaign=DE&utm_term=0B19D771-A501-4A5E-8338-2A822B784D54

## About the Role

* 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 working 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, * Master's degree in Engineering
 * Experience supporting hardware, electrical, mechanical, or electromechanical medical device products
 * Experience with statistical tools and software (e.g., Minitab, JMP)
 * ASQ certification (CQE, CRE, CMQ/OE)

## Description

* 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 (Failure Mode and Effects Analysis), 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 (VOE) 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.