Job Description Summary

Staff Design Quality Engineer to support product and process development within the Infusion Platform for New Product Development.

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 Staff Design Quality Engineer will play a crucial role in ensuring the quality and regulatory compliance of CareFusion 303, Inc.'s medical devices throughout their entire product lifecycle, from design and development through to market release. This position will involve active participation in design control activities, risk management, and fostering a culture of quality within the engineering teams.

Job Responsibilities
Design Control & Development:

• Actively participate in product design and development activities, providing quality engineering support and guidance.

• Review and approve design inputs, design outputs, design verification, and design validation plans and reports.

• Ensure compliance with design control procedures, medical device regulations (e.g., FDA 21 CFR Part 820, ISO 13485), and company policies.

• Contribute to the development and maintenance of Design History Files (DHFs).

Risk Management:

• Lead and facilitate risk management activities, including the development and maintenance of risk management plans, hazard analyses, and FMEAs (Failure Mode and Effects Analyses).

• Ensure appropriate risk mitigation strategies are implemented and verified.

Post-Market Surveillance & CAPA:

• Support post-market surveillance activities by analyzing complaint data and identifying potential quality issues.

• Participate in root cause analysis and corrective and preventive action (CAPA) investigations related to design quality.

• Contribute to the effectiveness verification of CAPA actions.

Compliance & Audits:

• Support internal and external audits (e.g., FDA, ISO) by providing documentation and technical expertise related to design quality.

• Ensure ongoing compliance with all applicable quality system regulations and standards.

Training & Mentorship:

• Provide guidance and training to engineering teams on design control, risk management, and quality system requirements.

• Act as a mentor to junior quality engineers.

Job Qualifications
Education:

• Bachelor's degree in Engineering (Biomedical, Mechanical, Electrical, or related field) required. Master's degree preferred.

Experience:

• 5+ years of experience in Design Quality Engineering within the medical device industry.

• Demonstrated experience with medical device design controls (21 CFR Part 820.30) and risk management (ISO 14971).

• Strong understanding of ISO 13485 quality management system requirements.

• Experience with Design Verification and Validation activities including software, system, and human factors testing.

• Experience in requirements decomposition, traceability, and test strategy development.

• Understanding of change impact analysis and regression test scoping methods.

Skills:

• Excellent analytical and problem-solving skills.

• Strong communication (written and verbal) and interpersonal skills, with the ability to effectively collaborate with cross-functional teams.

• Proficiency in statistical analysis and quality tools.

• Ability to interpret and apply complex regulatory requirements.

• ASQ certifications (e.g., CQE, CRE) preferred.

• Proficiency in relevant software tools (e.g., TeamCenter, Polarion, AzureDevOps, PLM systems).

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

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Primary Work Location

USA CA - San Diego TC Bldg C&D

Additional Locations

Work Shift

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

$124,700.00 - $205,800.00 USD Annual