Principal Quality Systems Engineer - Capital Equipment

Boston Scientific•Arden Hills, MN

16h•Hybrid

About The Position

The Principal Quality Engineer - Capital Equipment Systems represents the capital equipment quality function within Project Magellan, Boston Scientific’s global transformation program deploying SAP S/4HANA and the global service management system. This role partners with business process owners, IT, quality, and commercial operations teams to define quality and business process requirements and translate them into scalable system solutions. The position ensures that systems are designed, implemented, and function as intended to support compliant, efficient, and traceable capital equipment operations across the commercial lifecycle, including service, repair, distribution, and redeployment. In addition, this role supports global rollout activities, including change management, training, and communication, while driving consistency and alignment of quality processes and standards across regions and functions. As a principal-level individual contributor, this position provides strategic leadership and subject matter expertise at the intersection of quality, digital systems, and global commercial operations, shaping how capital equipment requirements are embedded into enterprise platforms and driving alignment across regions and functions.

Requirements

Bachelor’s degree in engineering, science, or a related field.
Minimum of 7 years' experience in quality, engineering, operations, software quality assurance, or related roles.
Minimum of 3 years' experience in the medical device or regulated industry.
Experience with business process design and requirements definition.
Knowledge of quality systems and global regulatory expectations.

Nice To Haves

Experience leading business process design and requirements definition in large-scale system transformations.
Experience with SAP S/4HANA, global service management systems, or similar enterprise platforms.
Deep understanding of commercial lifecycle operations, including service, repair, distribution, and logistics.
Experience with capital equipment and associated regulatory considerations.
Familiarity with user acceptance testing and business validation methodologies.
Experience in organizational change management, training, and global deployments.
Knowledge of FDA, EU MDR, and international regulatory frameworks.
Demonstrated ability to influence at senior levels and operate effectively in a global matrix organization.

Responsibilities

Serve as the global quality subject matter expert for capital equipment within Project Magellan across service, repair, distribution, and redeployment.
Define and drive the strategy for embedding capital equipment quality and regulatory requirements into business processes and system capabilities.
Influence cross-functional decisions to ensure solutions support compliant, scalable, and future-state operations.
Lead collaboration with global capital equipment business process teams, IT, and subject matter experts to define end-to-end processes aligned with SAP S/4HANA and global service management systems.
Translate complex quality system requirements into business process and system requirements.
Ensure processes are designed to deliver compliant outcomes with appropriate controls, traceability, and data integrity.
Provide leadership across key domains, including service and repair operations, distribution and logistics, import and export requirements, and redeployment of capital equipment.
Provide expert review and guidance on system and process designs to ensure alignment with capital equipment quality and regulatory expectations.
Identify and drive resolution of cross-functional risks, gaps, and compliance considerations.
Shape decisions that balance compliance, operational efficiency, and system scalability.
Lead capital equipment quality input into user acceptance testing strategy and execution.
Define quality-critical business scenarios, use cases, and acceptance criteria reflective of global operations.
Ensure solutions are validated as fit for purpose to support compliant commercial lifecycle processes.
Provide leadership in organizational change management to support adoption of new processes and systems.
Oversee development and alignment of procedures, work instructions, training strategies, and business readiness activities.
Ensure capital equipment quality considerations are embedded in global rollout and adoption plans.
Drive alignment between future-state processes and the Boston Scientific quality system.
Lead updates and enhancements to quality system processes, controls, and documentation impacted by Project Magellan.
Champion opportunities to improve compliance, efficiency, and user experience through digital enablement.
Influence and align senior stakeholders across quality, IT, commercial, and operations functions.
Act as a key bridge between technical and business teams, ensuring clarity of quality requirements and priorities.
Provide clear communication on risks, decisions, and readiness to program leadership.