Director, Design Quality (Medtech)

Location: Remote - US

Estimated annual pay range: $182,000.00–$237,000.00

Company

hirify.global develops digital healthcare solutions combining wearable biosensors, cloud-based analytics, and proprietary algorithms to deliver clinically actionable cardiac health insights.

What you will do

• Lead, develop, and resource Design Quality Engineering teams across hardware and software disciplines.
• Oversee design controls, design transfer, risk management, verification and validation, human factors, and product lifecycle activities.
• Partner with R&D, Product Management, Manufacturing, Regulatory, Clinical, and Quality functions on quality strategies and product-development decisions.
• Improve design-related Quality Management System processes, metrics, and governance.
• Use complaint, field-performance, and post-market data to identify risks and prevent recurring quality issues.
• Represent Design Quality during FDA inspections, Notified Body audits, regulatory interactions, and executive reviews.

Requirements

• At least 15 years of related experience with a bachelor’s degree, or equivalent experience in a medical, science, or healthcare field.
• At least 5 years of management experience with direct reports.
• Expert knowledge of design controls, Critical-to-Quality strategies, risk management, and cybersecurity.
• Knowledge of mechanical, electrical, and software engineering for complex devices.
• Knowledge of software development lifecycles, including embedded software, firmware, applications, analytics, and software quality for connected products.
• Must be able to work remotely from the United States.

Nice to have

• Experience with AI-based devices, Software as a Medical Device, or wearable medical devices.
• Master’s or advanced degree.
• Experience with mobile device applications and remote software installation.

Culture & Benefits

• Patient- and customer-focused quality culture with an emphasis on collaboration and organizational change.
• Medical, dental, and vision insurance starting on the first day.
• Paid holidays, paid time off, and paid parental leave.
• 401(k) with company match and an Employee Stock Purchase Plan.
• Pet insurance discount and cultural committee and charity events.