Design Quality Engineer II

Job Description Summary

As Directed by the Quality manager, the Design Quality Engineer II is accountable for supporting product design changes and product maintenance through the application of quality engineering skills for medical devices. this person will play active role in the processes to ensure products meet quality standards consistent with both corporate and business unit policies while meeting all design control and other regulatory requirements.

Job Description

We are the makers of possible

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.

We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you'll be supported to learn, grow and become your best self. Become a maker of possible with us.

Job Summary
The Quality Engineer II will support the development, implementation, and maintenance of quality systems to ensure products meet established standards and regulatory requirements. This role involves active participation in all phases of the product lifecycle, from design to post-market surveillance, to drive continuous improvement and product excellence.

Job Responsibilities

• Develop, implement, and maintain quality plans, procedures, and specifications in accordance with internal standards and regulatory requirements (e.g., FDA, ISO 13485).
• Participate in design control activities, including design reviews, risk management (DFMEA, PFMEA), and verification/validation planning and execution.
• Conduct root cause analysis for product non-conformances, customer complaints, and deviations, and implement effective corrective and preventive actions (CAPA).
• Lead or support internal and external audits (e.g., supplier audits, regulatory inspections) to ensure compliance with quality system requirements.
• Analyze quality data (e.g., trend analysis, defect rates, yield) to identify areas for improvement and drive continuous improvement initiatives.
• Collaborate with cross-functional teams including R&D, Manufacturing, Regulatory Affairs, and Supply Chain to resolve quality issues and promote a culture of quality.
• Perform statistical analysis to evaluate process capability, product reliability, and validate test methods.
• Review and approve manufacturing documentation, engineering changes, and process validations.
• Train and mentor junior quality personnel on quality system requirements and best practices.
• Prepare and present quality reports and metrics to management.

Job Qualifications

• Bachelor's degree in engineering (e.g., Biomedical, Mechanical, Electrical, Industrial).
• Minimum 3 years of experience in a design quality engineering role within medical device industry.
• Strong understanding of quality system regulations and standards (e.g., FDA 21 CFR Part 820, ISO 13485).
• Proven experience with root cause analysis methodologies (e.g., 8D, 5 Whys, Fishbone diagrams) and CAPA systems.
• Proficiency in statistical analysis tools and techniques (e.g., Minitab, SPC, Gage R&R).
• Demonstrated experience in design control, risk management, and verification/validation activities.
• Excellent written and verbal communication skills with the ability to effectively interact with all levels of the organization.
• Ability to work independently and as part of a cross-functional team in a fast-paced environment.
• ASQ certifications (e.g., CQE, CSSBB) are a plus.

At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.

For certain roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.

Why Join Us?

A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It's also a place where we help each other be great, we do what's right, we hold each other accountable, and learn and improve every day.

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 health. At BD, you'll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.

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.

Required Skills

Optional Skills

.

Primary Work Location

USA CA - San Diego TC Bldg C&D

Additional Locations

Work Shift

NA (United States of America)

At BD, we are strongly committed to investing in our associates-their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture. We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under Our Commitment to You.

Salary or hourly rate ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates' progress, ranging from entry level to experts in their field, and talent mobility. There are many factors, such as location, that contribute to the range displayed. The salary or hourly rate offered to a successful candidate is based on experience, education, skills, and any step rate pay system of the actual work location, as applicable to the role or position. Salary or hourly pay ranges may vary for Field-based and Remote roles.

Salary Range Information
$80,600.00 - $133,000.00 USD Annual