Business Process Owner (BPO), Risk Management

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. 

This position is a temporary assignment which will include benefits (such as medical, health, dental, 401k). Eligibility for these benefits will be based on eligibility requirements as determined by the BD Total Rewards policy. This position will support remediation activities within MMS and is anticipated to last approximately through March 31, 2026.

The Risk Management Business Process Owner (BPO), Dispensing is accountable for influencing risk management process activities for product development and product maintenance through the application of quality management and engineering skills for medical devices. This person will support Engineers from product inception through product launch and maintenance and play an active role in the processes to ensure products meet quality standards consistent with both Corporate and business unit policies, while meeting all risk management and other regulatory requirements. This person may also assist with compliance remediation, design control, change control, or wider product development process management projects.

Job Description Summary:

• Applies medical device development expertise to provide leadership in the creation and maintenance of product risk management processes based in 14971 regulation.

• The Business Process Owner provides strategic and tactical direction and oversight to ensure consistent leadership for Product Risk Management.

• This individual monitors internal and external regulatory observations and trends and implements changes across the business units.

• This position will also participate in other QMS tactical and strategic activities as needed, including but not limited to Design Control and Change Control process activities.

Responsibilities:

In accordance with all applicable federal, state and local laws/regulations and Corporate BD, procedures and guidelines, this position is responsible for:

• Owns and ensures Product Risk Management is effectively implemented within the Dispensing and Software Technology Solutions (STS) business units

• Works in conjunction with the Risk Management BPO for Infusion and Product Development Process leadership to maintain a comprehensive risk management program across the MMS business unit.

• Participates on a team bringing core product development and post-market business processes to the MMS business

• Serves as subject matter authority on Product Risk Management

• Leads continuous process improvements and partners with SME’s on key initiatives

• Ensures consistent application of product risk management activities across all elements of the Quality System (e.g. CAPA, Field Actions, etc)

• Establishes training requirements and orchestrates training for Product Risk Management

• Monitors performance of Product Risk Management and reports to senior leadership

• Benchmark trends in the industry, identify best practices and deploy at BD

• Monitors industry surveillance audit outcomes and takes necessary actions to align process to applicable new or revised regulatory requirements and standards

• Monitors internal and external audit observations within BD, identifies the appropriate cause and implements fixes across the enterprise for Product Risk Management

• Works with standards committee to monitor for external regulatory changes. Determines need for changes to policy, procedure and practices based on regulatory changes and implements where appropriate

• Supports regulatory inspections and audits

• Participate collaborative community (cross site/cross functional network of SMEs) which will support and drive change

Education and Experience:

• Requires a minimum of a BS/MS degree in life science, engineering or other relevant discipline. Experience with both hardware and software applications is preferrable.

• At least 8 years of experience in a Class I/II/III medical device with specific experience in Risk Management

• Proven experience with interpretation and application of ISO 14971, FDA CFR 820.30 and other regulation related to Product Risk Management

• Demonstrated experience establishing global Quality strategy & oversight, QMS etc., at business/manufacturing site level in a global company.

• Strong background in Risk Management in relation to product design and development and post-market risk management activities

• Strong understanding of design control requirements and regulation

• Proven ability as a change agent to drive improvements across a large organization.

• Strong technical writing experience required.

• Excellent problem solving and analytical skills.

• Ability to develop creative approaches and solutions necessary to resolve complex problems.

• Strong communicator capable of interfacing at senior levels.

• Understanding of the application of quality systems to the medical device industry.

• Ability to work effectively and influence leading decision makers across diverse areas of BD and manage complex structures.

• Proven ability to work globally; ability to lead a global team and lead across cultures and regions.

• Articulate 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.

• Travel is required, given the global scope of the role, and would vary in intensity depending on the evolving business needs.

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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