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.

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 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 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.

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.

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