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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.

Our vision for the Director, Quality Assurance at BD

Lead the development, establishment and maintenance of Quality Assurance and Engineering programs, processes and controls during design, development, and transfer; ensuring that performance and quality of new products in Infusion business conform to product requirements, established standards and regulations, and exceed customer expectations. Success will be measured by robust Verification and Validation prior to launch that translates to high product quality performance post launch. Through internal and external partner engagement and personnel development, this role ensures that projects produce high quality products in a timely and efficient execution. Product safety, product quality, product reliability and compliance with all members of Core Teams and Program Management will be ensured through effective communication, excellent problem solving and active management of ambiguous situations.

This role will lead a team based in San Diego, CA working with the Vice President of Quality, US Infusion Platform.

About the role:

This position leads a platform new product quality team and is charged with defining and implementing outstanding Quality practices, in accordance with

The BD Way and Quality Management Systems, for:

Design Assurance and DFX programs

Design Quality Engineering, including sustaining design change activities, Software Quality Engineering (embedded, applications and analytics), Cybersecurity, Risk Management, Verification and Validation activities, Reliability Engineering, Human Factors, Test Method Development and Validation Safety Assurance Case practices

The position will be a member of the Infusion Platform Team and as such they and team leadership will represent the interests of Quality and Compliance within that Infusion platform business.

This leader shall be proficient in the development of design process requirements and leading the core team through vital diligence and decisions related to conformance to those requirements throughout the new product development life cycle.

Design Excellence— While quality principles are well-founded in the industry, the position is responsible for identifying superior processes to enable compliance and suitable product quality levels. Critical-To-Quality initiatives will be the driving force behind focusing this team on the critical characteristics of Infusion products.

Key responsibilities will include:

• Develop strategic quality programs and foster: Design changes, New Products, product enhancements, material changes, software creation and maintenance and represent Design Controls expert-level leadership and guidance for a dedicated team

• This role is a highly matrixed and influential role having responsibility for a specific portfolio

As such, this leader must have a strong understanding and execution of:

• Development of teams including succession planning organization design and deployment, multi-functional influence and negotiation, and organizational leadership through change

• Define and influence rapid transformation of ideas to requirements to products and deliberate compliance to internal quality management system requirements in design and development

• Platform-wide authority and accountability for developing, deploying, and maintaining a robust and quality management system for the design, risk management, and ongoing life-cycle maintenance of BD products

• Actively identify improvements to the processes within the QMS to enhance both compliance and quality

• Provide expert-level understanding of design control requirements and how to deploy them in a large-scale, evolving business.

• Provide leadership during FDA and Notified body site inspections

• Work with the FDA on Pre-Market Activities: Design Controls, Risk Management, Test Methods, Safety Assurance Case, Human Factors

• Acquire and develop leaders and teams to support the Infusion new product platforms and actively lead bench-strength and succession planning

• Represent the Quality Function in all product planning activities, such as the Platform Development Team (PDT)

• Identify Quality Initiatives to address field Quality issues, define prevention mechanisms for future development projects and lead teams to complete them

• Provide diligent and fact-based communication to Executive Management team, peers, and team

• Assess resource needs to align the required level of quality support provided when needed with suitable competencies, including shifting resources between Platforms when appropriate.

• Maintain effective design-related Quality Metrics and define and implement activities to improve performance

• Actively support and demonstrate the BD values in daily work

• Effectively partner with R&D to define work and solve technical issues

• Engage with (or may lead) quality networks as well as the business unit and associates toward the effective promotion and alignment of organizational goals to the company’s mission and vision

• Ensure effective design transfer between development and manufacturing

• Serves as Quality Program Leader for sophisticated projects

• Ensures successful development, verification, validation, and transfer of design

• Supervise and influence key support functions that enable these goals including Supplier Quality, Sourcing, Manufacturing Risk Management, etc.

About you:

• Proven experience leading Quality Engineers in a Design Assurance Organization

• 15 years of engineering experience in the Medical Device Industry supporting Class II/III devices or other regulated industry.

• Prior Director level leadership experience in Infusion Systems or other capital equipment medical product with broad experience with sophisticated, electromechanical, and software devices

• Proven expert-level knowledge of Design Controls, Design for Six-Sigma, Critical-to-Quality strategies, Risk Management, Cybersecurity, Safety Assurance Cases, and Human Factors, etc.

• Proven knowledge in Software development lifecycle, including familiarity with embedded software and firmware, applications software and analytics; knowledge of cybersecurity process for medical devices is highly desirable.

• Ability to travel up to 25%

• Strong leadership skills with demonstrated ability to deliver excellent results

• Strong project management, team skills, and influential management are also highly desired

• ASQ certifications CQE, CSQE, CRE, CMQ/OE, CSSGB and/or CSSBB highly desired.

• Experience leading or supporting FDA and/or Notified Body inspections

• Excellent communication skills (up, down, and outward)

• Commanding knowledge of methods for designing robust/reliable products including design review, verification & validation testing, trace matrix, risk management, design planning, Statistical sampling/plan selection

• Authority in FDA Design Controls, ISO 13485, and standards and regulations covering Medical Devices.

Education and experience required :

• Requires a minimum of a BS degree in science, engineering, or relevant subject area

• Proven experience leading Quality Engineers in a Design Assurance Organization (10 years desired)

• Engineering experience in the Medical Device Industry supporting Class II/III devices or other regulated industry (15 years minimum desired).

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.

You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. You will have the opportunity to help shape the trajectory of BD while leaving a legacy at the same time. And through the organization’s investment in BD University, you will continually level up your tech skills and expertise.

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.

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

$179,200.00 - $322,500.00 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.