Design Control Process Manager

El Camino Health; United States; On-site; 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

Career-defining. Life-changing. At iRhythm, you’ll have the opportunity to grow your skills and your career while impacting the lives of people around the world. iRhythm is shaping a future where everyone, everywhere can access the best possible cardiac health solutions. Every day, we collaborate, create, and constantly reimagine what’s possible. We think big and move fast, driven by our commitment to put patients first and improve lives. We need builders like you. Curious and innovative problem solvers looking for the chance to meaningfully shape the future of cardiac health, our company, and your career.

About this role

We are seeking a medical‑device Design Control Process Manager who brings firsthand R&D (engineering) experience and can translate quality and regulatory requirements into clear, practical processes that engineers can follow. The ideal candidate will have experience creating SOPs, procedures, templates, and implementation plans, while building strong partnerships across R&D, Quality, and Regulatory. This individual should be an effective advocate for R&D, a credible educator, and a change leader who can increase design control fluency and drive consistent adoption across R&D and product‑development teams.

Key responsibilities

Design control process management

Develop, establish, implement, and continuously improve design control processes governingEnsure design control processes meet applicable FDA and ISO requirements and are appropriately integrated into product-development activities. Translate quality and regulatory requirements into clear, scalable, and executable procedures, tools, templates, and working practices. Evaluate the effectiveness of design control processes and recommend updates based on product-development needs, quality data, regulatory expectations, audit observations, and industry best practices. Create a scalable implementation plan for deployment of new and updated design control requirements across new product development, sustaining engineering, remediation, and product‑change activities.

Design history file and traceability

Establish and maintain processes and SOPs that support complete, accurate, and audit-ready Design History Files from user needs through design validation. Partner with project teams to identify and resolve documentation, traceability, and design control gaps.

Quality assurance and compliance

Plan, implement, and manage quality assurance protocols and methods supporting medical‑device design, development, transfer, and production readiness. Ensure processes align with applicable internal quality standards and external regulatory requirements for products intended for worldwide distribution. Review quality, development, and production information to identify trends, recurring issues, and opportunities to improve quality standards and procedures. Support compliance with applicable FDA requirements, ISO13485, ISO14971, and other relevant product‑development standards. Apply knowledge of 21CFR Part11, IEC60601, IEC62366, and IEC62304, as applicable, to product‑development projects and design control processes.

Risk management

Lead or facilitate product and design risk‑management activities, including hazard analyses and Design Failure Mode and Effects Analyses. Ensure risk‑management activities are appropriately linked to design requirements, verification, validation, risk controls, and post‑control risk evaluation. Partner with technical and quality teams to identify, document, evaluate, and mitigate product and process risks. Support alignment between design control and risk‑management processes throughout the product lifecycle.

Cross‑functional partnership

Collaborate with Research and Development, Quality, Regulatory Affairs, Manufacturing, and other functional partners to ensure design control processes are compliant, practical, and executable. Serve as a trusted advisor and champion for design control and design assurance best practices. Influence cross‑functional teams and drive consistent adherence to established design control processes. Facilitate alignment and resolution when quality, regulatory, technical, or operational requirements conflict.

Qualifications

• Education: BS in Engineering or related technical discipline.
• Experience: 12+ years in medical device Quality Assurance or Design Assurance.
• Demonstrated knowledge of FDA 21CFR820, 21CFRPart11, ISO13485, and ISO14971.
• Apply knowledge of IEC60601, IEC62366, and IEC62304 to product development projects.
• Tools: Experience with QMS software (e.g., MasterControl, Veeva Vault) and Document Control systems.
• Demonstrated ability to influence cross‑functional teams and drive adherence to design control processes.
• Strong track record of partnering across Quality, Regulatory, R&D and Manufacturing to embed design controls seamlessly into product development.
• Ability to serve as a trusted advisor and champion for design control best practices.
• Ability to travel US domestic and international as needed.

Location: Remote - US

Actual compensation may vary depending on job-related factors including knowledge, skills, experience, and work location.

Estimated Pay Range $151,000.00 - $196,000.00

As a part of our core values, we ensure an inclusive workforce. We welcome and celebrate people of all backgrounds, experiences, skills, and perspectives.

iRhythm Technologies, Inc. is an Equal Opportunity Employer. We will consider for employment all qualified applicants with arrest and conviction records in accordance with all applicable laws.

iRhythm provides reasonable accommodations for qualified individuals with disabilities in job application procedures, including those who may have any difficulty using our online system. If you need such an accommodation, you may contact us at [e-mail].

About iRhythm Technologies

iRhythm is a leading digital healthcare company that creates trusted solutions that detect, predict, and prevent disease. Combining wearable biosensors and cloud‑based data analytics with powerful proprietary algorithms, iRhythm distills data from millions of heartbeats into clinically actionable information.

Through a relentless focus on patient care, iRhythm’s vision is to deliver better data, better insights, and better health for all.

Make iRhythm your path forward. Zio, the heart monitor that changed the game.

Driven by purpose

Cardiac health touches the lives of people all around us. Providing life‑changing healthcare solutions that impact patients around the world drives us to bring our best every single day.

Growth means opportunity

We are growing rapidly. And with that growth comes a wealth of opportunities to learn and advance at iRhythm. The potential to deepen your impact, seek new opportunities and advance your career is yours to pursue.

Build the future

We are a boundary‑pushing organization that values innovative thinking and impacts healthcare at a global level. The expectation is to think big and build the future you see for iRhythm, our patients, and yourself.