Senior Quality Engineer – Trending And Data Analytics (Medtech)

TL;DR

Senior Quality Engineer (Medtech): Performing trending and analysis of customer feedback, complaints, and quality system data with an accent on data-driven quality improvement for Cardiac Ablation Solutions. Focus on defining and validating new data sources, escalating trending signals, and providing critical data requests to cross-functional partners.

Location: Must be based in Mounds View, MN (requires 4 days onsite per week)

Salary: $98,400 – $147,600 USD

Company

A global healthcare technology leader focused on alleviating pain, restoring health, and extending life through medical innovation.

What you will do

• Perform trending analysis for Cardiac Ablation Solutions products to identify quality signals.
• Escalate trending signals to appropriate stakeholders for corrective action.
• Provide cross-functional partners with critical data requests and insights.
• Define, test, and validate new data sources and quality reports.

Requirements

• Bachelor’s degree in engineering, math, statistics, or a related technical discipline.
• Minimum 4 years of experience in Engineering, Science, or Data Analysis (or an advanced degree with 2+ years).
• Hands-on experience working with relational databases.
• Proficiency in data analysis tools such as PowerBI, Spotfire, or Tableau.
• Must possess unrestricted U.S. work authorization at the time of hire.

Nice to have

• Experience in the Medical Device industry and regulated environments.
• Knowledge of FDA 21 CFR Part 820 and EU MDR (217/745) regulations.
• Familiarity with ISO 13485, ISO 14971, and IEC 60601 standards.
• Experience with Snowflake, SAP Business Objects, Minitab, or JMP.
• Background in report or software validation and continuous improvement.

Culture & Benefits

• Comprehensive health, dental, and vision insurance including HSA and FSA options.
• 401(k) plan with employer contribution and match.
• Employee Stock Purchase Plan (ESPP) and incentive plans (MIP).
• Tuition assistance and reimbursement programs.
• Paid time off, paid holidays, and global well-being program (Simple Steps).