Sr. Director, Design Assurance, Infusion Platform Quality

Job Description Summary

This role will be responsible for leading 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 and strong transfer to manufacturing leadership prior to launch that translates to high product quality performance post launch that exceed customer expectations.

Through internal and external stakeholder engagement and personnel development, this role ensures that projects produce high quality products, compliant and on-time deliverables 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 and will report to the Vice President of Design Quality Management, Infusion Platform and Development Quality.

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 Med Tech 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 leads the Infusion platform new product development and support quality team and is charged with defining and executing superior 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 Cross-functional Infusion Platform Team and as such they and team leadership will represent the interests of Quality within that Infusion platform business.

This leader shall be proficient in the development of design process requirements and leading the core team through the necessary 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.

• This leader must develop strategic quality programs to oversee 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 of infusion 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 quality culture that enables both rapid transformation of ideas to product requirements being diligent and deliberate in compliance to…