Job Description Summary

Job Description

The Vice President, Design and Development Quality for the MMS-based Infusion business will be responsible for leading the developing, establishment and maintenance of the quality assurance and engineering programs, policies, processes, procedures and controls during design, development and transfer; ensuring that performance and quality of infusion products globally  conform to product requirements, established standards and regulations. This role will lead a team based in San Diego, CA. and provide subject guidance for our Eysins, Switzerland and other global sites conducting design and development activities.

This position leads a broad 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 Reliability Engineering Human Factors Test Method Development and Validation Safety Assurance Case practices

The Vice President will be a member of the Cross-functional Infusion Platform Team and as such they and team leadership will represent the interests of Quality and Compliance within the Medication Management Solutions business unit. 

The Vice President will ensure that people and processes within the global Design & Development Quality function are capable of active management and improvement of product quality and compliance.  As the San Diego site is under a Consent Decree, the Vice President has the responsibility to comply with the conditions set forth under the decree.  This position is responsible for significant portions of QMS and product remediation activities within the business. This position reports to the VP of MMS Quality Management and is on the succession path for functional leadership.

The Vice President, Design and Development Quality - Infusion will help drive the MMS business strategy as follows:

Product Risk Management – this position is responsible for the effectiveness of MMS Quality Management System and continued reduction of risks inherent in MMS products and services.  As such, defining and maintaining a comprehensive Risk Management Program for all products is required and for Safety Assurance Cases, where required.  Included here are full responsibility for software and cybersecurity quality practices. This position is responsible for understanding where poor quality in design may impact our stakeholders using field feedback data and implementing prevention and improvement processes and projects to reduce that impact.

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 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 MMS products.

Responsibilities:

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 broad global 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 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.

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)

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.

Maintain effective design-related Quality Metrics and define and execute activities to improve performance. Actively support and demonstrate the BD values in daily work.

Other assignments as directed by the MMS VP of Quality.

Requirements:

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

Prior leadership experience in Infusion Systems or other durable goods capital equipment medical products.

At least 20 total years’ experience, with at least 15 years’ experience leading a Quality Engineering Team in the Medical Device Industry supporting Class II/III 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 of mechanical and electrical 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

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)

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