Design Control Process Manager

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $151k - $196k / year

⏰ Full Time

🟠 Senior

🔴 Lead

⚙️ Operations

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iRhythm Technologies, Inc.

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2006

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

iRhythm Technologies, Inc. is a medical technology company that specializes in digital healthcare solutions for the management of cardiac arrhythmias. The company is best known for its ZioSuite, a comprehensive platform designed to deliver a streamlined solution for assessing heart health through advanced analytics and patient-centered data collection. iRhythm focuses on improving patient outcomes and optimizing the efficiency of healthcare providers through innovative technology in the cardiac monitoring space.

📋 Description

• Develop, establish, implement, and continuously improve medical-device design control processes • Ensure design control processes meet FDA and ISO requirements and integrate into product-development activities • Translate quality and regulatory requirements into procedures, tools, templates, and working practices • Evaluate process effectiveness and recommend updates based on product-development needs, quality data, regulatory expectations, audit observations, and industry best practices • Create implementation plans for new and updated design control requirements across new product development, sustaining engineering, remediation, and product-change activities • Establish and maintain SOPs supporting complete, accurate, and audit-ready Design History Files • Partner with project teams to resolve documentation, traceability, and design control gaps • Plan, implement, and manage quality assurance protocols for medical-device design, development, transfer, and production readiness • Review quality, development, and production information to identify trends and improvement opportunities • Support compliance with FDA, ISO 13485, ISO 14971, 21 CFR Part 11, IEC 60601, IEC 62366, and IEC 62304 • Lead or facilitate hazard analyses and Design Failure Mode and Effects Analyses • Link risk-management activities to design requirements, verification, validation, risk controls, and post-control risk evaluation • Identify, document, evaluate, and mitigate product and process risks • Collaborate with R&D, Quality, Regulatory Affairs, Manufacturing, and other functional partners • 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 processes • Facilitate resolution of conflicting quality, regulatory, technical, and operational requirements

🎯 Requirements

• BS in Engineering or related technical discipline • 12+ years in medical device Quality Assurance or Design Assurance • Demonstrated knowledge of FDA 21 CFR 820, 21 CFR Part 11, ISO 13485, and ISO 14971 • Knowledge of IEC 60601, IEC 62366, and IEC 62304 • Experience with QMS software such as MasterControl or Veeva Vault • Experience with Document Control systems • Demonstrated ability to influence cross-functional teams and drive adherence to design control processes • Strong track record partnering across Quality, Regulatory, R&D, and Manufacturing • Ability to serve as a trusted advisor and champion for design control best practices • Ability to travel US domestic and international as needed

🏖️ Benefits

• Opportunity to grow skills and career • Reasonable accommodations for qualified individuals with disabilities in job application procedures