Job Description Summary

The Staff Quality Engineer, Risk Management is responsible for the planning, coordination and execution of Risk Management activities for products in design & development with an emphasis on Cyber Security. They will lead cross-functional teams during the design and development of devices to ensure that all necessary risk management activities are executed in accordance with the quality system. The Staff Quality Engineer will partner with the Product Security Office to ensure cyber-security risks are understood and mitigated as required by standards.

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.

Remote candidates welcome, San Diego based candidates preferred.

Responsibilities:

• Collaborate with engineering, design, commercial, and product teams to ensure that all hazards associated with products are identified, the associated risks are estimated, evaluated, controlled and documented; monitors that the risk controls are implemented, verified, and validated for products in development.

• Ensure that the product risk management files adequately address cyber-security risks as required by applicable standards.

• Plan and implement the management of risk for projects to ensure that risk management is performed efficiently and in sufficient detail in support of new product development.

• Perform and document Risk Reviews to communicate results of the risk management process to the multi-functional teams.

• Ensure harmonization of risk management strategies across projects and their lifecycle by communicating with other Risk team members that share in varying pieces of the risk management lifecycle

• Review quality system results to ensure they are compliant with applicable standards and the QMS.

• Find opportunities for continuous improvement of the Risk Management Process

Other Functions:

• Facilitate and provide ongoing training on standards/processes as needed to other associates or functions.

• Assist with critical initiatives/planning.

Required Qualifications:

• ​Bachelor’s degree

• Minimum 5 years of applicable experience in risk management and cybersecurity ​

• Experience in medical device and/or regulated industry

• Experienced with ISO 13485 and ISO 14971

• Strong cross-functional collaboration skills

• Demonstrated expertise in AAMI TIR57, IEC 80001, etc

​ Preferred Qualifications:

• Technical experience with Pyxis or automated dispensing cabinets.

• IEC 60601 and IEC 62304 experience.

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/Affirmative Action Employer. We do not unlawfully discriminate on the basis of 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, or any other protected status.

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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 (https://jobs.bd.com/benefits) .

Salary 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 offered to a successful candidate is based on experience, education, skills, and actual work location. Salary ranges may vary for Field-based and Remote roles.

Salary Range Information

$121,100.00 - $199,800.00 USD Annual

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of 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, or any other protected status.