Software Quality Director (Medtech)

TL;DR

Software Quality Director (Medtech): Leads the software quality organization for medical devices, ensuring reliability, performance, and customer satisfaction for current and new products with an accent on defining long-term quality strategy, managing a high-performing team, and ensuring regulatory compliance. Focus on driving quality initiatives, overseeing software design assurance and risk management across the product portfolio.

Location: This position is in Mounds View, MN, United States, requiring on-site work 4 days per week.

Salary: $202,400.00 - $303,600.00 USD (Annual)

Company

hirify.global is a global healthcare technology corporation dedicated to alleviating pain, restoring health, and extending life through medical innovations, uniting over 95,000 passionate people worldwide.

What you will do

• Develop and execute a comprehensive software quality strategy.
• Collaborate with global partners on quality and digital transformation goals.
• Lead, mentor, and grow a diverse software quality engineering team.
• Oversee software design assurance and risk management for all software products.
• Ensure regulatory compliance (FDA, ISO 13485, IEC 62304, etc.) and support audits/submissions.
• Champion continuous improvement in software engineering, verification, validation, and documentation.

Requirements

• Bachelor’s degree in Computer/Software/Electrical Engineering or related discipline with a minimum of 10 years of software development experience OR Master's with a minimum of 7 years of software development experience.
• A minimum of 7 years of managerial experience.
• Experience in software quality assurance or software development in the medical device industry (7+ years preferred).
• Experience leading teams in Agile/Scrum environments (5+ years preferred).
• In-depth knowledge of relevant standards and regulations (IEC 62304, ISO 13485, FDA QSR, ISO 14971).
• Demonstrated experience with software engineering and product quality for Capital SiMD, SaMD, and Non-Medical Device Software.
• This role requires on-site work 4 days per week in Mounds View, MN, United States.
• Must have US work authorization.

Nice to have

• Experience with Agile/Scrum methodologies and continuous improvement frameworks (Lean, Kaizen).
• Scaled-Agile Principles awareness and execution experience.
• Software reliability best practices.
• Product Security Risk Management.
• AI/ML based software release experience.

Culture & Benefits

• Competitive Salary and flexible Benefits Package.
• Health, Dental, and Vision insurance.
• Health Savings Account and Healthcare Flexible Spending Account.
• 401(k) plan with employer contribution and match.
• Paid time off and paid holidays.
• Employee Stock Purchase Plan and Employee Assistance Program.
• Inclusive culture that values diversity and innovation.