Design Quality Engineer III

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

Job summary

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.

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 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.

Skills

Design Quality Engineering

Regulatory knowledge (FDA 21 CFR Part

Risk management (ISO14971)

Design controls

ASQ CQE certification

Education

Bachelor’s degree in Engineering

Tools

Minitab

JMP

Job description

We are the people who give possibilities purpose

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.

Job Description

Job 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 (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.

Job Qualifications:

Minimum Requirements

• 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

Preferred Qualifications

• 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)

Why Join Us?

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive.

We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.

To learn more about BD visit https://bd.com/careers.

Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics.

Primary Work Location

USA CA - San Diego Bldg A&B

Work Shift

At BD, we reward, support and develop our associates through our comprehensive Total Rewards program. We are committed to attracting and retaining high quality talent by providing reward and recognition opportunities that promote a performance-based culture, as well as a competitive package of compensation and benefits programs. You can learn more on our career site under "Our Commitment to You".

Our salary or hourly rate ranges reward associates fairly and competitively. We regularly review these ranges and factors, such as location, contribute to the range displayed.

Our pay is based on the role and the necessary skills and education to perform it successfully. The salary or hourly rate offered is determined by the role's specific requirements, including any applicable step rate pay system at the work location. Salary or hourly pay ranges are influenced by labor laws and Collective Bargaining Agreement (CBA) requirements applicable to the work location which may also affect the workplace arrangement of the role.

Salary Range Information

$105,500.00 - $168,800.00 USD Annual