Senior Design Quality Director
About The Position
The Senior Design Quality Director is a leadership role shaping the Design Assurance strategy for a broad and impactful Interventional Cardiology portfolio. The Senior Design Quality Director role will set direction for how quality is built into product design, influence cross‑functional decision‑making at a global level, and lead a high‑impact, multi‑site organization responsible for patient safety, regulatory confidence, and product excellence. This role serves as the senior Design Quality voice across the division, partnering closely with R&D, Regulatory, Clinical, Operations, Manufacturing, and Program Leadership to enable innovation while ensuring robust, compliant, and risk‑based product development. This role has broad visibility and influence across new product development, sustaining engineering, and lifecycle management.
Requirements
- Minimum of a Bachelor's degree
- Minimum of 15 years of Design Quality engineering experience in a medical device or regulated environment or similar related work experience
- Minimum of 10 years of direct or indirect management experience
- Demonstrated ability to lead effectively across a broad set of cross functional partners/teams and diverse body of work/functions/sites in a highly matrixed environment
- 10% - 20% travel expectations
Nice To Haves
- Advanced degree.
- Experience supporting products that include software or embedded firmware.
- Proven ability to influence without authority and drive alignment across multiple stakeholders.
- Track record of applying industry standards and best practices to introduce new perspectives and improvements.
- High sense of urgency, strong execution focus, and comfort navigating change in dynamic environments.
Responsibilities
- Set the strategic direction for Design Quality across the product portfolio, balancing compliance, innovation, speed, and sound risk‑based decision making.
- Act as the senior Design Quality representative in cross‑functional governance forums, influencing product strategy, development priorities, and risk acceptance decisions.
- Ensure efficient compliance with all applicable global regulatory requirements through the design and execution of a robust quality system.
- Serve as a divisional subject‑matter expert in worldwide design quality and regulatory expectations.
- Ensure product safety, reliability, and quality through effective use of quality planning, risk analysis, statistical methods, and process controls across design and manufacturing stages.
- Minimize field events by building quality into product design, leveraging returned product analysis, corrective actions, timely investigations, and post‑market surveillance activities.
- Lead the execution of streamlined quality systems and methodologies that proactively identify, prioritize, and resolve design quality issues.
- Support audit readiness and inspection excellence across the product portfolio.
- Lead, develop, and grow a multi‑site Design Assurance organization supporting multiple product platforms across NPD, sustaining, and lifecycle management.
- Recruit, coach, and develop high‑performing leaders and technical talent within the Design Quality organization.
- Build strong succession pipelines and foster a culture of accountability, collaboration, and continuous improvement.
- Guide teams through change in a fast‑paced, highly matrixed, global environment.
- Partner closely with R&D, Regulatory Affairs, Clinical, PMO, Operations, and global manufacturing partners to embed quality into all stages of product realization.
- Influence and align diverse stakeholders to drive consensus and effective decision‑making across complex programs.
- Ensure clear communication and documentation of design quality assurance and compliance information across the division.
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What This Job Offers
Job Type
Full-time
Career Level
Director
