Sr. Software Quality Engineer (Reliability/Compliance)

Location: Mounds View, Minnesota, United States; minimum 4 days per week onsite. Travel requirement: less than 10%. Candidates must have unrestricted U.S. work authorization; sponsorship is not available for this senior-level role.

Salary: $103,200–$154,800 per year, plus eligibility for the hirify.global Incentive Plan.

Company

hirify.global develops medical technologies designed to alleviate pain, restore health, and extend life, serving patients across more than 150 countries.

What you will do

• Support software quality and reliability for Cardiac Ablation Solutions and Affera cardiac electrophysiology systems.
• Review and approve software requirements, design, development, integration, testing, verification, validation, tooling, and security documentation in the Design History File.
• Develop traceability, testability, and compliance documentation according to quality management system procedures.
• Participate in software risk analysis, defect assessments, quality metrics, and reliability strategy development.
• Support post-market issue assessments, health risk assessments, CAPAs, and product security testing strategies.
• Collaborate with R&D, regulatory affairs, clinical, and quality teams, including participation in live and virtual electrophysiology case learning.

Requirements

• Bachelor’s degree and at least 4 years of relevant experience, or a master’s degree with 2 years of relevant experience, or a PhD with no required experience.
• Experience supporting product development and working with software development teams.
• Ability to perform simple coding tasks and read, interpret, and understand existing software code.
• Knowledge of cybersecurity and software lifecycles in regulated environments.
• Experience with risk analysis documentation such as FMEAs and FTAs.
• Unrestricted U.S. work authorization is required at hire and throughout employment.

Nice to have

• At least 2 years of experience in medical devices or another regulated industry.
• Experience with Python, Qt, Docker, and Linux.
• Experience with cardiac and electrophysiology medical specialties.
• Quality systems or regulatory affairs certification, such as Six Sigma or ASQ.
• Advanced degree in a relevant field.

Culture & Benefits

• Cross-functional collaboration focused on quality, compliance, reliability, and patient outcomes.
• Health, dental, and vision insurance, with healthcare savings and flexible spending accounts.
• 401(k) plan with employer contribution and match, paid time off, and paid holidays.
• Tuition assistance, life insurance, disability coverage, and employee assistance resources.
• Employee Stock Purchase Plan and incentive compensation opportunities.