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Tactile Medical · 1 day ago

Senior Software Quality Design Assurance Engineer

St Paul, MN

Full-time

Onsite

Mid, Senior Level

$100K/yr - $151K/yr

5+ years exp

Tactile Medical is seeking a Senior Software Quality Design Assurance Engineer who will play a critical role in ensuring that software products meet safety, efficacy, and regulatory compliance standards. The engineer will collaborate with cross-functional teams to drive quality processes throughout the software lifecycle and maintain rigorous oversight of documentation and risk management.

Health CareMedicalMedical Device

Responsibilities

Lead software design assurance activities from concept through commercialization and post-market surveillance, including change management in sustaining

Ensure compliance with FDA 21 CFR Part 820, IEC 62304, ISO 13485, ISO 14971, and other applicable standards

Support documentation and readiness for 510(k) submissions and other regulatory filings, including cybersecurity-related deliverables across all platforms

Drive software design control and change management processes, including requirements traceability, verification, validation, and risk management. Act as process owner and subject matter expert by coaching and training cross functional team on quality requirements for software development

Participate in product development meetings to understand scope and requirements from the SQA perspective

Assist with maintenance of cybersecurity labeling for user guides, IFUs, and other documentation to align with regulatory expectations and product-specific requirements

Ensure Software elements of Design History Files (DHF), Device Master Records (DMR), and Device History Records (DHR) are complete, accurate, and audit ready

Manage software quality records and ensure alignment with project scope, timelines, and regulatory expectations

Oversee the software change management process and ensure all changes are properly assessed and documented for regulatory, risk, and validation impact

Implement and maintain cybersecurity controls in accordance with FDA’s latest guidance on premarket submissions

Collaborate with development teams to ensure device resiliency, threat modeling, and secure design practices are embedded throughout the lifecycle

Support internal audits, FDA inspections, and ISO audits related to cybersecurity, software development and quality assurance

Mentor and train engineering teams on software quality processes, standards, and compliance expectations

Promote a culture of quality, accountability, and continuous improvement across engineering and product teams

Qualification

FDA standardsISO standardsCybersecurityRisk managementSoftware quality assuranceEmbedded systemsMobile applicationsCloud-based platformsASQ CSQEAgile methodologiesScrum methodologiesDevOps methodologiesCommunication skillsProblem-solving skillsCross-functional collaboration

Required

Bachelor's degree in Engineering, Computer Science, or related field

5+ years of experience in software quality assurance within the medical device industry

Strong knowledge of FDA, IEC, and ISO standards for medical device software, including cybersecurity and risk management requirements

Experience with embedded systems, mobile apps, and cloud-based platforms

Excellent communication, documentation, and cross-functional collaboration skills

Preferred

ASQ CSQE (Certified Software Quality Engineer)

Experience with electronic document control systems (such as Grand Avenue Software) for managing quality and development documentation, versioning, and traceability

Hands-on use of SBOM (Software Bill of Materials) tools for tracking software components and supporting regulatory submissions

Familiarity with Ketryx or similar quality applications that integrate R&D and Quality for medical device software compliance

Proven ability to collaborate across teams (R&D, Regulatory, IT, QA) and communicate quality requirements clearly