BD · 14 hours ago
Sr. Director, Design Assurance, Infusion Platform Quality
USA CA - San Diego Bldg A&B
Full-time
Onsite
Director/Executive
15+ years expBD is one of the largest global medical technology companies in the world. This role will lead the development and maintenance of Quality Assurance and Engineering programs for new products in the Infusion business, ensuring compliance with standards and exceeding customer expectations.
Health CareMedical DeviceTechnical Support
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
Qualification
Required
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
At 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
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
Preferred
MS or higher strongly preferred
Knowledge of cybersecurity process for medical devices is highly desirable
ASQ certifications CQE, CSQE, CRE, CMQ/OE, CSSGB and/or CSSBB highly desired
Benefits
Valuable, competitive package of compensation and benefits programs
Rewards and recognition opportunities that promote a performance-based culture
Company
BD helps advance clinical therapy with the process for patients and health care providers with innovative technology services and solutions.
10001+ employees
H1B Sponsorship
BD has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (66)
2022 (4)
2021 (3)
Funding
Current Stage
Public CompanyTotal Funding
$540MKey Investors
Steris
2023-08-02Post Ipo Equity· $540M
1962-04-23IPO
Leadership Team
Tom Polen
Chairman, CEO and President
Richard Byrd
Executive Vice President and President of the BD Interventional Segment
Recent News
2026-01-22
Medical Device Network
2026-01-22
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