Software Quality Engineer II - Complaint Investigation Site (CIS)

Requisition ID: 635969

About the 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.

Responsibilities

• 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

Pay

Minimum Salary: $71,500; Maximum Salary: $135,800. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs.

Schedule

This hybrid role is based in Arden Hills, MN and requires being on-site at least four (4) days per week. Relocation assistance is not available for this position at this time. Visa sponsorship is not offered for this position at this time.