Senior Software Quality Design Assurance Engineer
24 hours ago
Hybrid onsite, MN
Job Description:
- The candidate must have experience with software projects, preferably with embedded systems.
- Familiarity with document control systems like Grand Avenue and experience creating documentation such as standard operating procedures and work instructions is required.
- Understanding of cybersecurity management processes and the ability to interpret reports from software, firmware, and cybersecurity testing is important.
- System level thinking is very important understanding how system components work such the parts of our products like, garment, controller, mobile apps, cloud back-end work, and firmware
- Medical device experience required
Position Summary
The 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 is integral to supporting 510(k) submissions and ongoing product releases, with a special focus on cybersecurity deliverables in line with the latest FDA guidance.
The engineer will serve as a subject matter expert in software quality, collaborating with cross-functional teams to define, implement, and monitor 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.
Accountabilities & Responsibilities
Regulatory Compliance Oversight
- Ensure all software development and maintenance activities comply with FDA 21 CFR Part 820, IEC 62304, ISO 13485, and ISO 14971
- Support documentation and readiness for 510(k) submissions and other regulatory filings, including cybersecurity-related deliverables across all platforms.
- Participate in product development meetings to understand scope and requirements from the SQA perspective.
- Maintain dashboards and checklists to report on project artifact status and dependencies.
- Assist with maintenance of cybersecurity labeling for user guides, IFUs, and other documentation to align with regulatory expectations and product-specific requirements
- Define, maintain, and enforce SOPs for software development and quality assurance.
- Ensure Design History Files (DHF), Device Master Records (DMR), and Device History Records (DHR) are complete, accurate, and audit-ready
- Manage creation, revision, and archival of quality and development documentation using Grand Avenue Software or equivalent QMS tools.
- Assign and track Document Control Numbers (DCNs) and ensure proper versioning and traceability.
- Route and monitor Document Change Requests (DCRs) for timely review and approval.
- Assist teams with document categorization, ensuring alignment with regulatory and internal standards.
- Identify and implement process improvements in documentation workflows
- Prepare for and support FDA inspections, ISO audits, and internal quality audits.
- Conduct or coordinate internal audits to ensure ongoing compliance and identify areas for improvement
- Oversee the SCA process to evaluate the impact of software changes.
- Ensure all changes are properly assessed for regulatory, risk, and validation impact.
- Verify updates to documentation, risk assessments, and test coverage are complete and traceable
- 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.
- Own and maintain cybersecurity labeling and documentation for all software deliverables.
- Ensure team members are trained on relevant standards, SOPs, and quality processes.
- Promote a culture of compliance, accountability, and continuous improvement across engineering and product teams.
- Create and train new members of the software quality function.
- Provide periodic refresher training and point training when procedures are created or updated
Education & Experience
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 510(k) process, IEC 62304, ISO 13485, ISO 14971.
- Familiarity with FDA cybersecurity guidance and risk-based design principles.
- Experience with embedded systems, mobile apps, and cloud-based platforms.
- Excellent communication, documentation, and cross-functional collaboration skills.
Preferred:
- 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.
- Strong knowledge of FDA, IEC, and ISO standards for medical device software, including cybersecurity and risk management requirements
- Proven ability to collaborate across teams (R&D, Regulatory, IT, QA) and communicate quality requirements clearly.
Knowledge & Skills
- Strong analytical, problem-solving, and communication skills for identifying, troubleshooting, and documenting software quality issues.
- Experience with electronic document control systems (e.g., Grand Avenue Software) for managing, versioning, and ensuring traceability of quality and development documentation
- Hands-on use of SBOM (Software Bill of Materials) tools for regulatory compliance, software component tracking, and supporting FDA submissions.
- Familiarity with quality and compliance platforms such as Ketryx or similar applications for automating traceability, risk management, and regulatory documentation workflows.
- 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
- Understanding of risk management principles and cybersecurity best practices for medical device software, including threat modeling and secure design.
- Experience supporting 510(k) submissions, including preparation and review of software documentation, risk assessments, and cybersecurity deliverables.
- Proficiency in software testing methodologies: functional, regression, system, integration, user acceptance, and exploratory testing.
- Familiarity with Agile, Scrum, and DevOps methodologies for efficient software development and quality assurance processes.
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