Sr. Director, Design Assurance, Infusion Platform Quality

Becton Dickinson Medical Devices•San Diego, CA

13d

About The Position

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. 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. Job Description 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.

Requirements

Requires a minimum of a BS degree in science, engineering, or relevant discipline. MS or higher strongly preferred.
At least 10 years of experience managing Quality Engineers in a Design Assurance Organization
A least 15 years of engineering experience in the Medical Device Industry supporting Class II/III devices or other regulated industry.
Prior leadership experience in Infusion Systems or other electromechanical medical device equipment with broad experience with complex, hardware and software based devices
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 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 also highly desired
Demonstrated individual and team development, leadership and collaboration
ASQ certifications CQE, CSQE, CRE, CMQ/OE, CSSGB and/or CSSBB highly desired.
Experience leading, and demonstrated effectiveness in supporting FDA and/or Notified Body inspections as the direct interface for the Quality Development, Risk Management, Software, Hardware, and Cyber functional areas
Excellent communication skills (up, down, and outward), capable of effective communication in Senior Leadership reviews
Expert knowledge of methods for designing robust/reliable products including design review, verification & validation testing, trace matrix, risk management, design planning, Statistical sampling/plan selection
Expert knowledge of FDA Design Controls, ISO 13485, and standards and regulations covering Medical Devices.

Responsibilities

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.
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 internal quality management system requirements.
Platform-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.
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 leaders and teams to support the Infusion new product platforms and actively manage 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 cross-functional 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.
Possess a servant leadership approach with focus on developing Quality Engineering associates
Maintain effective design-related Quality Metrics and define and execute activities to improve performance.
Actively support and demonstrate the BD values in daily work.
Effectively partner with R&D to define deliverables and troubleshoot 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 complex new product development projects.
Ensures successful development, verification, validation, and transfer of design.
Monitor and influence key support functions that enable these goals including Supplier Quality, Sourcing, Manufacturing Risk Management, etc.
Other assignments as directed by the VP of Quality Management – Infusion Platform.