Principal Analyst,Quality Business Process Job Arden Hills area,Minnesota USA,IT/Tech

Principal Analyst, Quality Business Process

Onsite Location(s):
Arden Hills, MN, 55112

Additional Location(s): US-MN-Arden Hills; US-CA-Valencia; US-IN-Spencer; US-MA-Marlborough; US-MA-Quincy; US-MN-Maple Grove; US-RI-Coventry

Work model, sponsorship, relocation: Hybrid work model requiring presence in the local office at least three days per week. No visa sponsorship or sponsorship of employment visas provided for this position.

Your responsibilities will include:

Strategic quality leadership: 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, influencing cross‑functional decisions to support compliant, scalable, and future‑state operations.
Business process design and requirements leadership: Lead collaboration with global capital equipment business process teams, IT, and subject‑matter experts to define end‑to‑end processes aligned with SAP S/4

HANA and global service management systems. Translate complex quality system requirements into business process and system requirements, ensuring processes deliver compliant outcomes with appropriate controls, traceability, and data integrity.
Operational domain leadership: Provide leadership across key domains, including service and repair operations, distribution and logistics, import and export requirements, and redeployment of capital equipment.
Solution design influence and risk management: 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, shaping decisions that balance compliance, operational efficiency, and system scalability.
User acceptance testing and business validation: Lead capital equipment quality input into user acceptance testing strategy and execution. Define quality‑critical business scenarios, use cases, and acceptance criteria reflecting global operations, ensuring solutions are validated as fit for purpose to support compliant commercial lifecycle processes.
Change management, training, and deployment readiness: 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, embedding capital equipment quality considerations in global rollout and adoption plans.
Quality system integration and continuous improvement: 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, championing opportunities to improve compliance, efficiency, and user experience through digital enablement.
Global stakeholder influence and alignment: 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 while providing clear communication on risks, decisions, and readiness to program leadership.

Required qualifications:

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.

Preferred qualifications:

Experience leading business process design and requirements definition in large‑scale system transformations.
Experience with SAP S/4

HANA, 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…