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 governing
• Ensure 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, ISO 13485, ISO 14971, and other relevant product-development standards.
• Apply knowledge of 21 CFR Part 11, IEC 60601, IEC 62366, and IEC 62304, 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 21 CFR 820, 21 CFR Part 11, ISO 13485, and ISO 14971. Apply knowledge of IEC 60601, IEC 62366, and IEC 62304 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

There have been instances where individuals not associated with iRhythm have impersonated iRhythm employees pretending to be involved in the iRhythm recruiting process, or created postings for positions that do not exist. Please note that all open positions will always be shown here on the iRhythm Careers page, and all communications regarding the application, interview and hiring process will come from a [redacted].com email address. Please check any communications to be sure they come directly from [redacted].com email address. If you believe you have been the victim of an imposter or want to confirm that the person you are communicating with is legitimate, please contact [redacted]. Written offers of employment will be extended in a formal offer letter from an [redacted].com email address ONLY.

For more information, see https://www.ftc.gov/business-guidance/blog/2023/01/taking-ploy-out-employment-scams and https://www.ic3.gov/Media/Y2020/PSA200121