Senior Design Quality Director

Senior Design Quality Director

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.

Responsibilities will include:

• 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.

Required Qualifications:

• 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

Preferred Qualifications:

• 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.

Work Model & Additional Information:

• Work mode: On-site model, four days per week, in the Arbor Lakes office site.
• Visa sponsorship: Not available for this position.
• Relocation assistance: Available.

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs. At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.

Compensation for non-exempt (hourly), non-sales roles may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation for exempt, non-sales roles may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.