Sr. Director, Design Assurance, Infusion Platform Quality

About This Role

Lead the development and maintenance of Quality Assurance and Engineering programs for new infusion product development, ensuring product performance and quality meet requirements and exceed customer expectations. This role drives robust Verification, Validation, and manufacturing transfer to ensure high product quality post-launch.

Responsibilities

• Lead the Infusion platform new product development and support quality team
• Define and execute superior Quality practices in accordance with The BD Way and Quality Management Systems
• Identify superior processes to enable compliance and suitable product quality levels, focusing on Critical-To-Quality initiatives
• Develop strategic quality programs to oversee and foster design changes, new products, and product enhancements
• Define and influence a quality culture that enables rapid transformation of ideas to product requirements while ensuring compliance
• Provide expert-level understanding of design control requirements and their deployment in a large-scale business
• Lead and manage a team of Quality Engineers, including succession planning and organizational design
• Interface with the FDA on Pre-Market Activities, including Design Controls, Risk Management, and Human Factors
• Represent the Quality Function in all product planning activities, such as the Platform Development Team (PDT)
• Maintain effective design-related Quality Metrics and define/execute activities to improve performance

Requirements

• Minimum of BS degree in science, engineering, or relevant discipline
• 10+ years experience managing Quality Engineers in a Design Assurance Organization
• 15+ years 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
• Expert-level knowledge of Design Controls, Design for Six-Sigma, Critical-to-Quality strategies, Risk Management, Cybersecurity, Safety Assurance Cases, and Human Factors
• Strong leadership skills with demonstrated ability to deliver excellent results
• Expert knowledge of FDA Design Controls, ISO 13485, and standards and regulations covering Medical Devices

Qualifications

• BS degree in science, engineering, or relevant discipline. MS or higher strongly preferred.
• Minimum of 10 years experience managing Quality Engineers in a Design Assurance Organization, and at least 15 years engineering experience in the Medical Device Industry supporting Class II/III devices or other regulated industry.

Nice to Have

• MS or higher degree
• Knowledge of Software development lifecycle, including embedded software, applications software and analytics
• Knowledge of cybersecurity process for medical devices
• Strong project management, team skills, and influential management
• ASQ certifications CQE, CSQE, CRE, CMQ/OE, CSSGB and/or CSSBB

Skills

* Required skills

Certifications