Design Control Process Manager

🕒 August 19

🇺🇸 United States – Remote

💵 $151k - $196k / year

⏰ Full Time

🟠 Senior

🔴 Lead

⚙️ Operations

👻 Ghost score 0%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

Apply Now

Find Similar Remote Jobs

Set Up Email Alert For New Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

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