Senior Software Quality Design Assurance Engineer

<div class="content-intro"><p>At Tactile Medical, we specialize in developing at-home therapy devices to treat lymphedema, chronic venous insufficiency and respiratory illnesses.</p></div><p><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;"><strong>Overview</strong></span><br><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">The Senior Software Quality Design Assurance Engineer is a pivotal member of the product development and quality teams, responsible for ensuring that all software—embedded firmware, mobile applications, and cloud-based platforms—meets the highest standards of safety, efficacy, and regulatory compliance. This role ensures compliance with global regulatory standards and internal quality policies, driving excellence in software design, cybersecurity, documentation, and risk management.</span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">The engineer will serve as a subject matter expert in software quality, collaborating with cross-functional teams to define, implement, and maintain quality processes throughout the software lifecycle. By maintaining rigorous oversight of documentation, risk management, and change control, the engineer ensures audit readiness and continuous improvement. The role also champions a culture of compliance and accountability, providing training and guidance to engineering and product teams on evolving standards and best practices.</span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;"><strong>Responsibilities</strong></span></p> <ul> <li style="font-family: arial, helvetica, sans-serif; font-size: 10pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Lead software design assurance activities from concept through commercialization and post-market surveillance, including change management in sustaining.</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 10pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Ensure compliance with FDA 21 CFR Part 820, IEC 62304, ISO 13485, ISO 14971, and other applicable standards.</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 10pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Support documentation and readiness for 510(k) submissions and other regulatory filings, including cybersecurity-related deliverables across all platforms.</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 10pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Drive software design control and change management processes, including requirements traceability, verification, validation, and risk management. Act as process owner and subject manner expert by coaching and training cross functional team on quality requirements for software development.</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 10pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Participate in product development meetings to understand scope and requirements from the SQA perspective.</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 10pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Assist with maintenance of cybersecurity labeling for user guides, IFUs, and other documentation to align with regulatory expectations and product-specific requirements. </span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 10pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Ensure Software elements of Design History Files (DHF), Device Master Records (DMR), and Device History Records (DHR) are complete, accurate, and audit ready.</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 10pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Manage software quality records and ensure alignment with project scope, timelines, and regulatory expectations.</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 10pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Oversee the software change management process and ensure all changes are properly assessed and documented for regulatory, risk, and validation impact.</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 10pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Implement and maintain cybersecurity controls in accordance with FDA’s latest guidance on premarket submissions.</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 10pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Collaborate with development teams to ensure device resiliency, threat modeling, and secure design practices are embedded throughout the lifecycle.</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 10pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Support internal audits, FDA inspections, and ISO audits related to cybersecurity, software development and quality assurance.</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 10pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Mentor and train engineering teams on software quality processes, standards, and compliance expectations.</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 10pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Promote a culture of quality, accountability, and continuous improvement across engineering and product teams.</span></li> </ul> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;"><strong>Qualifications</strong></span><br><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Education & Experience:</span><br><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Required:</span></p> <ul style="margin-top: 0in; margin-bottom: 0in;" type="disc"> <li style="line-height: 115%; margin-top: 0in; margin-right: 0in; margin-bottom: 0in; font-size: 10pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 10pt; line-height: 115%; font-family: arial, helvetica, sans-serif;">Bachelor’s degree in Engineering, Computer Science, or related field.</span></li> <li style="line-height: 115%; margin-top: 0in; margin-right: 0in; margin-bottom: 0in; font-size: 10pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 10pt; line-height: 115%; font-family: arial, helvetica, sans-serif;">5+ years of experience in software quality assurance within the medical device industry.</span></li> <li style="margin-top: 0in; margin-right: 0in; margin-bottom: 0in; font-size: 10pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">Strong knowledge of FDA, IEC, and ISO standards for medical device software, including cybersecurity and risk management requirements.</span></li> <li style="line-height: 115%; margin-top: 0in; margin-right: 0in; margin-bottom: 0in; font-size: 10pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 10pt; line-height: 115%; font-family: arial, helvetica, sans-serif;">Experience with embedded systems, mobile apps, and cloud-based platforms.</span></li> <li style="line-height: 115%; margin-top: 0in; margin-right: 0in; margin-bottom: 0in; font-size: 10pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 10pt; line-height: 115%; font-family: arial, helvetica, sans-serif;">Excellent communication, documentation, and cross-functional collaboration skills.</span></li> </ul> <p><br><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Preferred:</span></p> <ul style="margin-top: 0in; margin-bottom: 0in;" type="disc"> <li style="margin-top: 0in; margin-right: 0in; margin-bottom: 0in; font-size: 10pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">ASQ CSQE (Certified Software Quality Engineer)</span></li> <li style="margin-top: 0in; margin-right: 0in; margin-bottom: 0in; font-size: 10pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">Experience with electronic document control systems (such as Grand Avenue Software) for managing quality and development documentation, versioning, and traceability.</span></li> <li style="margin-top: 0in; margin-right: 0in; margin-bottom: 0in; font-size: 10pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">Hands-on use of SBOM (Software Bill of Materials) tools for tracking software components and supporting regulatory submissions.</span></li> <li style="margin-top: 0in; margin-right: 0in; margin-bottom: 0in; font-size: 10pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">Familiarity with Ketryx or similar quality applications that integrate R&D and Quality for medical device software compliance.</span></li> <li style="color: black; margin-top: 0in; margin-right: 0in; margin-bottom: 0in; font-size: 10pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif; color: windowtext;">Proven ability to collaborate across teams (R&D, Regulatory, IT, QA) and communicate quality requirements clearly.</span></li> </ul> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Knowledge & Skills:</span></p> <ul style="margin-top: 0in; margin-bottom: 0in;" type="disc"> <li style="color: black; margin-top: 0in; margin-right: 0in; margin-bottom: 0in; font-size: 10pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">Strong analytical, problem-solving, and communication skills for identifying, troubleshooting, and documenting software quality issues.</span></li> <li style="color: black; margin-top: 0in; margin-right: 0in; margin-bottom: 0in; font-size: 10pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">Experience with electronic document control systems (e.g., Grand Avenue Software) for managing, versioning, and ensuring traceability of quality and development documentation </span></li> <li style="color: black; margin-top: 0in; margin-right: 0in; margin-bottom: 0in; font-size: 10pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">Hands-on use of SBOM (Software Bill of Materials) tools for regulatory compliance, software component tracking, and supporting FDA submissions.</span></li> <li style="color: black; margin-top: 0in; margin-right: 0in; margin-bottom: 0in; font-size: 10pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">Familiarity with quality and compliance platforms such as Ketryx or similar applications for automating traceability, risk management, and regulatory documentation workflows.</span></li> <li style="color: black; margin-top: 0in; margin-right: 0in; margin-bottom: 0in; font-size: 10pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">In-depth knowledge of FDA, IEC, and ISO standards for medical device software, including 21 CFR Part 820, IEC 62304, ISO 13485, ISO 14971, and current FDA cybersecurity guidance </span></li> <li style="color: black; margin-top: 0in; margin-right: 0in; margin-bottom: 0in; font-size: 10pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">Understanding of risk management principles and cybersecurity best practices for medical device software, including threat modeling and secure design.</span></li> <li style="color: black; margin-top: 0in; margin-right: 0in; margin-bottom: 0in; font-size: 10pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">Experience supporting 510(k) submissions, including preparation and review of software documentation, risk assessments, and cybersecurity deliverables.</span></li> <li style="color: black; margin-top: 0in; margin-right: 0in; margin-bottom: 0in; font-size: 10pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">Proficiency in software testing methodologies: functional, regression, system, integration, user acceptance, and exploratory testing.</span></li> <li style="color: black; margin-top: 0in; margin-right: 0in; margin-bottom: 0in; font-size: 10pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">Familiarity with Agile, Scrum, and DevOps methodologies for efficient software development and quality assurance processes.</span></li> </ul> <p> </p><div class="content-pay-transparency"><div class="pay-input"><div class="description"><p>Our total compensation package includes medical, dental and vision benefits, retirement benefits, employee stock purchase plan, paid time off, parental leave, family medical leave, volunteer time off and additional leave programs, life insurance, disability coverage, and other life and work wellness benefits and discounts. Benefits may be subject to generally applicable eligibility, waiting period, contributions, and other requirements and conditions.</p> <p> </p> <p>Below is the starting salary or hourly range for this position, although offers may differ based on the candidate's location, job-specific knowledge, skills and experience.</p></div><div class="title">US Pay Range</div><div class="pay-range"><span>$100,500</span><span class="divider">—</span><span>$150,675 USD</span></div></div></div><div class="content-conclusion"><p>To learn more about our Privacy Statement follow this link - <a href="https://tactilemedical.com/privacy-statement/">https://tactilemedical.com/privacy-statement/</a></p> <p>To learn more about our California Privacy Notice follow this link - <a href="https://tactilemedical.com/california-privacy-notice/" target="_blank">https://tactilemedical.com/california-privacy-notice/</a></p></div>