Quality Engineer II

Quality Engineer II

Boston Scientific was recognized by Forbes as one of the Best Workplaces for Engineers in 2026, reflecting a culture where engineers do meaningful work.

Join the Arden Hills Post Market Complaint Investigation Site (CIS) as a Quality Engineer II, where you'll investigate post-market product performance, identify opportunities for continuous improvement and help ensure the safety and quality of innovative medical devices. Supporting the Interventional Oncology and Embolization (IO&E) division, you'll collaborate with cross-functional teams to analyze complaint data, investigate field performance signals and improve products across a portfolio of single-use devices, capital equipment and accessories.

This role is focused on advancing product and process performance by increasing actionable investigation outcomes and expanding the use of Engineering Essentials and data-driven problem-solving techniques. The position identifies, prioritizes and executes projects aligned with departmental, divisional and global objectives while leading continuous improvement initiatives that strengthen complaint investigation processes and enhance product performance. The role offers significant visibility across site and divisional leadership.

Analyze customer complaints, events and other post-market surveillance data to identify patterns, trends and performance improvement opportunities.

Conduct product signal escalation analyses, investigations and quality system documentation to identify performance improvement opportunities. This may include ownership of Nonconforming Event Prevention (NCEP) investigations and Corrective and Preventive Actions (CAPAs).

Provide technical guidance to product investigators in identifying and resolving quality issues using Engineering Essentials and other structured problem-solving methodologies.

Expand team utilization of investigative equipment, including X-ray, Fourier-transform infrared spectroscopy (FTIR) and scanning electron microscopy (SEM).

Partner with cross-functional teams to develop and implement streamlined, robust complaint investigation processes while ensuring compliance with organizational and regulatory requirements.

Communicate product performance findings through formal presentations to management committees and design teams, published product performance reports and customer performance requests in partnership with the sales organization.

Champion continuous improvement initiatives across local and global Post Market organizations to improve product performance and complaint investigation processes.

Foster a diverse and inclusive workplace that enables all employees to contribute to their full potential in pursuit of organizational objectives.

Demonstrate a primary commitment to patient safety and product quality by maintaining compliance with the Quality Policy and all documented quality system processes and procedures.

Bachelor's degree in engineering or another related technical or scientific discipline.

Minimum of 1 year's experience in a highly regulated industry or quality organization.

Knowledge of Quality System Regulations (QSR), Medical Device Regulation (MDR) and ISO 13485 quality standards.

Experience in the medical device industry or within a quality organization.

Proficiency with Microsoft Office applications, including Word, Excel, PowerPoint and Outlook.

Ability to collaborate with and influence cross-functional teams.

Knowledge of analytical techniques, structured problem-solving methodologies, continuous improvement principles and statistical analysis.

Self-starter with the ability to identify and implement improvement opportunities.