Job Description Summary

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. 

The Staff Quality Risk Management Engineer is responsible for planning, coordination and execution of Medication Management Solutions (MMS) Infusion Risk Management activities for products in design & development as well as production/post-production. This position will work closely with cross-functional development teams to create and complete the risk management (RM) strategy, processes, and deliverables throughout the design and development process across BD products. They will apply a risk-based approach throughout the development phases of infusion pumps and supporting products and facilitate the risk management deliverables to support regulatory filings, product launch, and post-market surveillance risk management framework.

This role is responsible for ensuring that MMS Infusion risk management process is executed to align with local procedures, ISO requirements, FDA regulations, and other regional or country post-market regulations.  This position bridges the Risk Management process to conduct risk management activities for primarily post market device phase while also operating effectively in the capacity of premarket risk activities.

HYBRID ROLE - 4 Days per week onsite, San Diego, CA - 1 day per week, remote. Ideal candidate will reside within commutable distance from our San Diego location.

Role Responsibilities:

Collaborate with engineering, design, commercial, and product teams to ensure

that all hazards associated with medical devices are identified, the associated risks are estimated, evaluated, controlled and documented; and monitors that the risk controls are implemented, verified, and validated for products in development and post-production change management.

Plan and execute the management of risk for medical device projects to ensure that risks are reduced to acceptable levels in an efficient manner and with sufficient detail for the total product life cycle.

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

Articulates with ability to influence others and significantly promote and/or negotiate in situations that involve recognizing and responding to underlying concerns where others need to be persuaded to accept compromised solutions. Identifies opportunities for improvements to the MMS Infusion Risk

Management process through various data sources (e.g., stakeholder feedback, Six Sigma techniques, monitoring internal and external audit observations, etc.).

Drive continuous improvement efforts, through facilitating, leading, and collaborating with cross-functional teams.  This requires determining fixes/improvements/strategies that can include process, product and/or training and follow through on plans of action necessary for implementation.

Able to manage all aspects of the CAPA process: initiation, investigation, planning, implementation, verification of effectiveness and TrackWise administration to support nonconformities cited to involve Risk Management.

Provide leadership and guidance to teams on the risk management process and RM feeder quality systems. 

Effectively manage projects and present status reports to designated functional leaders according to established frequencies and recommended templates.

Provide leadership to MMS Business Unit functions to ensure consistency in risk assessments and implements solutions and process efficiencies, wherever possible.

Work on additional ad hoc projects, as assigned.

Required Education and Skills:

Bachelor’s degree, and a minimum of 5+ years in the medical device industry or experience in a similar regulated environment (e.g., Quality, Design Controls, or Risk Management), or a Master’s degree with a minimum of 3+ years of pertinent experience.

Solid understanding of QA, Regulatory, and Quality Compliance in the medical device industry.

Exhibit strong oral and written communication (included knowledge of good documentation practices) and interpersonal skills.

Master organizational skills to manage multiple tasks and projects.

Present with high technical problem solving, the ability to work in teams, critical thinking, the ability to adapt to a rapidly changing environment, and desire to contribute to meaningful and innovative products.

Advanced knowledge of FDA/ISO applicable guidance, regulations and standards including ISO 14971, ISO 62304, TIR 57, IEC 62366, 21 CFR 820.30, HE 75, Human Factors FDA Guidance: Applying Human Factors and Usability Engineering to Medical Devices.

Show evidence of detail-oriented practices and proven accuracy in record keeping practices

Strong proficiency with MS Office tools (i.e., Word, Excel, PowerPoint, Outlook).

Preferred Knowledge and Skill:

Knowledge of infusion pumps/infusion therapy.

Have experience in TrackWise and SAP.

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/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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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.

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