Design Control Process Manager (Medical Device)

Location: Remote - US; travel within the US and internationally may be required.

Salary: $151,000–$196,000 per year.

Company

hirify.global is a digital healthcare company developing wearable biosensors, cloud-based data analytics, and proprietary algorithms for cardiac health monitoring.

What you will do

• Develop, implement, and continuously improve medical-device design control processes.
• Translate FDA, ISO, and other regulatory requirements into practical procedures, SOPs, tools, templates, and implementation plans.
• Establish audit-ready Design History File and traceability processes from user needs through design validation.
• Plan and manage quality assurance protocols supporting medical-device design, development, transfer, and production readiness.
• Lead or facilitate hazard analyses, Design FMEA, and other product and process risk-management activities.
• Partner with R&D, Quality, Regulatory Affairs, Manufacturing, and technical teams to drive consistent adoption of design control practices.

Requirements

• BS degree in Engineering or a related technical discipline.
• 12+ years of experience in medical-device Quality Assurance or Design Assurance.
• Knowledge of FDA 21 CFR 820, 21 CFR Part 11, ISO 13485, and ISO 14971.
• Experience applying IEC 60601, IEC 62366, and IEC 62304 to product-development projects.
• Experience with QMS software such as MasterControl or Veeva Vault and with document-control systems.
• Demonstrated ability to influence cross-functional teams and drive adherence to design control processes.

Culture & Benefits

• Remote work arrangement within the US.
• Opportunity to contribute to cardiac health solutions and patient-focused medical technology.
• Collaboration across R&D, Quality, Regulatory Affairs, Manufacturing, and other functions.
• Inclusive workforce and reasonable accommodations for qualified applicants.