Software Quality Engineer II - Complaint Investigation Site; CIS

Position: Software Quality Engineer II - Complaint Investigation Site (CIS)
Additional Location(s):  N/ADiversity
- Innovation
- Caring
- Global Collaboration
- Winning Spirit
- High Performance At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.

About This Role:

This role leads investigational efforts at the Arden Hills Post Market Complaint Investigation Site (CIS), focusing on conducting investigations of returned products related to complaints, focusing primarily on Lithotrispy laser systems. Reviews return device data, completes investigation documentation and coding, and ensures conclusions align with testing results. Collaborates cross-functionally with teams such as Design Quality, R&D, Supplier Management, and Operations to support thorough analysis and risk understanding.

Escalates product issues, drives continuous improvement, and reports findings. Work mode:

At Boston Scientific, we value collaboration and synergy. This hybrid role is based in Arden Hills, MN and requires being on-site at least four (4) days per week. Relocation assistance:

Relocation assistance is not available for this position at this time.

Visa sponsorship:

Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.

Your Responsibilities Will Include:

Analyze system logs and post-market surveillance data to determine event root causes and identify safety or quality issues.

Lead product signal investigations, document findings, and drive corrective actions, including NCEPs and CAPAs as needed.

Partner cross-functionally to implement compliant process improvements that enhance CIS operations.

Communicate product performance insights to leadership, design teams, and customers through reports, presentations, and inquiries.

Ensure compliance with quality, regulatory, and patient safety requirements.

Required Qualifications:

Bachelor’s degree in engineering or other related technical/scientific discipline

Preferred Qualifications 2+ years of post-market complaint support or other related experience

Experience with capital equipment and/or log file analysis

Knowledgeable in Quality System Regulations, Medical Device Regulation, and ISO 13485 Quality Standards Experience in Medical Device industry or a Quality organization Proficient with Microsoft Office tools including Word, Excel, PowerPoint, and Outlook Ability to collaborate and influence across multiple, cross-functional teams Knowledge of analytical techniques, problem solving, continuous improvement programs, and statistical analysis Self-starter with the ability to identify improvement opportunities

Requisition  Salary: $ 71500

Maximum Salary: $ 135800

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see 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…