Design Controls Compliance — This position is responsible for ensuring the MMS Quality Management System elements affecting design and development are effective and efficient enabling risk control and reduction.  Compliance to requirements is a must.  This leader shall be proficient in the development of design process requirements and leading the organization through the necessary diligence and decisions related to conformance to those requirements throughout the product development life cycle.

Design Excellence—While quality principles are well-founded in our industry, the position is responsible foridentifying 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 MMS products.

Automation and AI – This role should have an understanding of the latest uses of AI agentic tools and their application to Quality process, product and systems analysis and improvement.

Responsibilities:

• This leader will be the single point of contact for Dispensing GM for all Quality and compliance matters. They will be responsible to develop strategic quality programs to oversee and foster: Design changes, New Products, product enhancements, product integrations, 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 broad global portfolio of Dispensing products’ design and development quality practices.  As such, this leader must be mature in their understanding and execution of:

• development of teams including succession planning

• organization design and deployment,

• cross-functional influence and negotiation, and

• broad organizational change management

• Define and influence a global quality culture that enables both rapid transformation of ideas to requirements to products and diligent and deliberate compliance to internal quality management system requirements in design and developing them.

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

• Responsible for Quality Improvement Plans related to Pyxis Medical Devices

• 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 and rapidly evolving business.

• Provide Design and Development leadership during FDA and Notified body site inspections.

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

• Acquire and develop excellent-level leaders and teams to support the MMS mission and actively manage bench-strength and succession planning.

• Represent the Quality Function in all product planning activities, such as the Platform Development Team (PDT). Conducts Quarterly Management Reviews with GM staff

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

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

• Assess resourceneeds 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 complete activities to improve performance. Actively support and demonstrate the BD values in daily work.

• Collaborate with functional peers to articulate Strategy and Execute

• Transfer of manufacturing facilities and validation

• Post Market Quality

• Efficiencies in complaint handling

• Build service quality capabilities

• Integrate open acquisitions and consolidate QMS

• Other assignments as directed by the MMS VP of Quality.

Requirements:

• A BS degree in a technical field (Engineering, Science, Math/Stat)

• At least 15years’of experience leadership of increasing levels in the Medical Device Industry supporting Class II/III devices

• 8+ years of Medical Device experience at Associate Director or Director level in 500M+ revenue companies

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

• Demonstrated knowledge of mechanical, electrical and software engineering in the development of complex devices

• Demonstrated knowledge in Software development lifecycle, including familiarity with embedded software and firmware, applications software and analytics; knowledge of software quality for mobile device apps and remote installation is a plus

• Ability to travel domestically and internationally, up to 25%

• Strong leadership skills with demonstrated ability to deliver excellent results

• Experience leading large teams (30+ employees.)

• Strong project management, team skills, and influential management 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

• Broad experience with complex, electromechanical, and software devices

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

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.

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 visithttps://bd.com/careers