Design Control Process Manager

iRhythm Technologies, Inc.

Design Control Process Manager advancing FDA- and ISO-compliant processes for iRhythm’s cardiac-health devices. Driving design assurance, risk management, traceability, and cross-functional adoption.

Posted 8/19/2026full-timeRemote • 🇺🇸 United StatesSeniorLead💰 $151,000 - $196,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Expertise in medical-device design control processes, ensuring compliance with FDA and ISO standards, and driving quality assurance protocols throughout product development. Proven ability to influence cross-functional teams and implement effective risk management strategies.

Highest-signal resume keywords

Medical Device Quality AssuranceFDA 21 CFR 820 ComplianceISO 13485 KnowledgeQMS Software ExperienceDesign Control Best Practices

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Design Control ProcessesRisk ManagementDesign History FilesQuality Assurance ProtocolsHazard AnalysisDesign Failure Mode and Effects AnalysisDocument Control SystemsRegulatory Requirements TranslationProcess Effectiveness EvaluationImplementation Planning

Soft Skills

Cross-Functional CollaborationInfluencing TeamsTrusted Advisor

Tools & Technologies

MasterControlVeeva Vault

Industry Keywords

FDA ComplianceISO 14971IEC 60601IEC 62366IEC 6230421 CFR Part 11

Tech Stack

Tools & technologies

Vault

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

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