Software Quality Engineer (Medtech)

TL;DR

Software Quality Engineer (Medtech): Supporting quality assurance for cardiac electrophysiology software systems with an accent on regulatory compliance, risk analysis, and documentation. Focus on ensuring product reliability and security through rigorous testing, verification, and cross-functional collaboration in a highly regulated medical environment.

Location: Must be based in Mounds View, Minnesota, USA (Hybrid: minimum 4 days a week onsite).

Salary: $64,800 – $97,200 USD.

Company

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

What you will do

• Support software quality efforts for cardiac ablation solutions, ensuring compliance with FDA, MDR, IEC 62304, and ISO 13485 standards.
• Participate in software risk analysis activities and maintain comprehensive risk file coverage.
• Review and approve Design History File documents, including requirements, test protocols, and validation reports.
• Collaborate with R&D, regulatory, and clinical teams to align on quality and compliance requirements.
• Contribute to post-market activities, including defect assessments and CAPA processes.
• Track software quality metrics to support continuous monitoring and improvement of product reliability.

Requirements

• Bachelor's degree required.
• Must possess unrestricted U.S. work authorization (sponsorship not available for this level).
• Proven ability to read, interpret, and understand software code to collaborate with engineering teams.
• Excellent written and oral communication skills.
• Ability to work onsite at least 4 days per week in Mounds View, MN.

Nice to have

• Experience with Python, Qt, Docker, and Linux.
• Background in medical devices or other regulated industries like defense or aerospace.
• Knowledge of cybersecurity and software lifecycles in regulated environments.
• Experience performing formal risk analysis.

Culture & Benefits

• Comprehensive health, dental, and vision insurance.
• 401(k) plan with employer contribution and match.
• Paid time off and paid holidays.
• Tuition assistance and reimbursement programs.
• Employee Stock Purchase Plan and short-term incentive plans.
• Commitment to professional growth and cross-functional collaboration.