Complaints Engineer

Job Title: Complaints Engineer

Location: Arden Hills, MN - 4 days per week onsite (Mon-Thurs).

*Think of this as QE (Complaints/CAPA/Post Market)

Leads technical investigation and escalation efforts across a range of Interventional Cardiology (IC) devices, with cross-divisional visibility.

What you'll own:

Analyze post-market surveillance data (complaints, adverse events) to drive timely investigation and resolution of safety and quality issues

Lead root cause investigations on escalated product signals and document findings in the quality system

May own NCEPs and CAPAs directly

Present product performance insights to leadership and design teams and support published performance reports

Mentor product investigators and drive utilization of investigative equipment such as X-Ray, FTIR, and SEM

Champion continuous improvement initiatives across local and global Post Market teams

Requirements:

Bachelor's degree in engineering or a related technical or scientific field (required)

ISO 13485, QSR, and MDR knowledge preferred

Strong cross-functional influence and statistical or analytical problem-solving skills

Note: The Complaints Engineer role is a good fit if you have a bachelor's degree in engineering or a related technical field and want a role with room to lead. You'll own root cause investigations end to end, take on CAPA and NCEP ownership, mentor other investigators, and present findings directly to leadership and design teams.