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 careerAbout 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 ResponsibilitiesDesign Control Process ManagementDevelop, 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 deve