Remote Medical Device Design Control Lead

El Camino Health; United States; Remote; USD 151,000 - 196,000; Full time

Job summary

iRhythm Technologies seeks a Design Control Process Manager with extensive R&D and QA/Design Assurance experience to translate regulatory requirements into practical processes. This role focuses on building scalable procedures, templates, and implementation plans that engineers can follow.

You will drive design control, risk management, and compliance across R&D, Quality, Regulatory, and Manufacturing, promoting audit readiness and cross‑functional adoption.

Qualifications

• BS in Engineering or related technical discipline.
• 12+ years in medical device Quality Assurance or Design Assurance.
• Knowledge of FDA 21CFR820, 21CFR Part11, ISO13485, and ISO14971.
• Apply knowledge of IEC60601, IEC62366, and IEC62304 to product development.
• Experience with QMS software and document control systems.
• Ability to influence cross‑functional teams and drive adherence to design control processes.
• Experience partnering across Quality, Regulatory, R&D and Manufacturing.
• Willingness to travel US domestic and international.

Responsibilities

• Develop, implement, and continuously improve design control processes.
• Ensure processes meet FDA/ISO requirements and integrate into product development.
• Create scalable deployment plans for new/updated design controls.
• Establish and maintain design history files and traceability.
• Plan and manage quality assurance protocols for design, transfer, and production readiness.
• Identify trends and opportunities to improve quality standards.
• Collaborate with R&D, Quality, Regulatory, Manufacturing to ensure compliance.
• Lead or facilitate design risk management activities (FMEA).

Skills

Cross-functional collaboration

Influence stakeholders

Regulatory compliance

Quality mindset

Change leadership

Education

BS in Engineering or related technical discipline

Tools

MasterControl

Veeva Vault

Document Control systems

Job description

iRhythm Technologies seeks a Design Control Process Manager with extensive R&D and QA/Design Assurance experience to translate regulatory requirements into practical processes. This role focuses on building scalable procedures, templates, and implementation plans that engineers can follow.

You will drive design control, risk management, and compliance across R&D, Quality, Regulatory, and Manufacturing, promoting audit readiness and cross‑functional adoption.