Quality Engineer II (Medtech)

TL;DR

Quality Engineer II (Medtech): Ensuring product quality, safety, and reliability for Cardiac Ablation Solutions through post-market activities and complaint investigations with an accent on risk file signals and product analysis. Focus on devising inspection methods for returned products and implementing statistical methodologies to assess performance trends.

Location: Onsite in Mounds View, Minnesota, USA. Must possess unrestricted U.S. work authorization

Salary: $79,200 - $118,800

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, processes, tools, and techniques for performing product analysis.
• Devise and implement methods and procedures for inspection and testing of returned products.
• Support test method validation activities and apply statistical methodologies.
• Provide training to technicians to ensure compliant execution of quality practices.

Requirements

• Bachelor’s degree in Engineering, Science, or a related technical discipline.
• Minimum of 2 years of relevant experience in Engineering or Quality (or 1+ year with an advanced degree).
• Unrestricted U.S. work authorization required at the time of hire (Sponsorship is not available for this level).

Nice to have

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

Culture & Benefits

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