Quality Engineer I (Medtech)

TL;DR

Quality Engineer I (Medtech): Ensuring product quality and safety through post-market activities for Cardiac Ablation Solutions with an accent on complaint investigations and risk signal escalation. Focus on developing inspection methods for returned products and implementing statistical methodologies to assess performance.

Location: Minneapolis, Minnesota, United States

Salary: $66,400 - $99,600

Company

hirify.global is a global leader in healthcare technology dedicated to alleviating pain, restoring health, and extending life.

What you will do

• Perform complaint investigations for Cardiac Ablation Solutions products.
• Collaborate with engineering teams to identify and escalate risk file signals.
• Develop procedures, tools, and techniques for product analysis and returned product evaluation.
• Implement inspection and testing methods for returned products and support test method validation.
• Apply statistical methodologies to assess product performance and trends.
• Provide training to technicians to strengthen compliant execution of quality practices.

Requirements

• Bachelor’s degree in Engineering, Science, or a related technical discipline.
• Must possess unrestricted U.S. work authorization at the time of hire.

Nice to have

• Experience in the medical device industry.
• Familiarity with FDA 21 CFR Part 820 and EU 217/745 (EU MDR).
• Knowledge of ISO 13485, ISO 14971, and IEC 60601 standards.
• Proficiency in Microsoft Office Applications.

Culture & Benefits

• Comprehensive health, dental, and vision insurance with HSA and FSA options.
• 401(k) plan with employer contribution and match.
• Paid time off, paid holidays, and short-term disability.
• Tuition assistance/reimbursement and Employee Stock Purchase Plan.
• Global well-being program (Simple Steps) and Employee Assistance Program.