Senior Test and Design Assurance Engineer

Position:               Senior Test and Design Assurance Engineer

Functional Area:  Software Engineering 

Department:         R&D 

Reports to:           Manager, Test Engineering 

Location:              Burlingame, CA

Company background

Magnus Medical, Inc. (“Magnus”) is an innovative company that has developed and commercialized a SaaS-based offering to provide a FDA-cleared, personalized and targeted treatment of patients with Treatment Resistant Depression. Magnus is also developing similar solutions for other mental health conditions including but not limited to bipolar disorder, postpartum depression, and anxiety. 

We are a venture-funded therapeutic medical devices company, led by industry veterans, with the mission of freeing individuals from the symptoms of depression and other neuropsychiatric diseases using personalized and accelerated neuromodulation technology. Our efforts are grounded in science, informed by clinical data, and inspired by the strength of those who live with psychiatric disease. We offer the ability to make the world a better place, in collaboration with like-minded colleagues who value communication, integrity, and cooperation. We are looking for individuals who are personally and boldly committed to improving treatment for mental health.

Role Description

The product is composed of Magnus Cloud and Magnus Neuromodulation software. The cloud analyzes fMRI to identify a personalized target within the brain linked to patients’ emotional state. This target is then passed on to the neuromodulation software which guides clinicians through treatment using SAINT.

As a Senior Test and Design Assurance Engineer, you will own product releases. This includes collaborating closely with developers to define test strategy, develop / review tests, as well as creating documentation for product releases in a regulated environment. 

Alongside testing, you will carry substantial design assurance responsibility: owning risk management inputs, requirements traceability, and the design history file evidence that supports our regulatory submissions, partnering with QA for independent review and approval of V&V deliverables. This is a senior individual contributor role with significant technical autonomy and influence over how V&V is practiced across the company. This position is hybrid, based in Burlingame, CA.

 

Roles and Responsibilities

• Design assurance
  • Maintain and update risk management file for new features / products, per ISO 14971
  •  Maintain and update requirements for new features / products at all levels (user needs, system requirements, and product requirements)
  • Define, review, and coordinate executing test plans and protocols
  • Maintain requirements traceability and design history file content
  • Support internal and external audits, FDA submissions, and notified body review
  • Define and lead improvements to the documentation process
• Release coordination
  • Define and maintain timeline of releases 
  • Coordinate release readiness across development, quality, regulatory, product, clinical, and commercial teams
  • Partner with Quality and Regulatory to ensure release documentation complies with medical device regulations
  • Define and lead release improvement projects
• V&V of product
  • Own the V&V strategy of releases
  • Design, build, and maintain automated and manual test suites including functional, integration, regression, performance, load, security, exploratory, and system testing
  • Identify, reproduce, triage, and drive resolution of defects
  • Author test plans, protocols, and reports, ensuring compliance with regulations
  • Lead testing improvement projects 
• Hybrid work based at Magnus Medical headquarters in Burlingame, CA
  • Regular onsite presence for collaboration with development, quality, and regulatory teams and for release activities

Required skills and qualifications

• Degree in computer science, engineering, or a related technical field, or equivalent practical experience
• 5+ years of software verification and validation experience, including at least 3 years in a regulated medical device environment
• Applied knowledge of IEC 62304, ISO 14971, and design controls, with experience authoring documentation that has supported a regulatory submission or audit
• Experience with version control and issue tracking systems, such as Git and Jira
• Demonstrated ownership of the V&V strategy for a regulated software product
• Knowledgeable in test automation
• Ability to set technical direction independently and work collaboratively across engineering, quality, regulatory, clinical, and commercial teams

Preferred qualifications

• Familiarity with HIPAA and SOC 2 requirements as they apply to verification evidence
• Familiarity, knowledge and/or experience with 21 CFR 820, Quality Management System Regulation, preferred/desired
  
• Hands-on experience testing cloud services and REST APIs, including automated API and integration testing
• Experience building and maintaining automated tests within CI/CD pipelines
• Experience with Software as a Medical Device (SaMD) or a connected device-plus-cloud system
• Working knowledge of AWS services and common cloud architecture patterns
• Experience with performance, load, and reliability testing and the tooling that supports it
• Experience with containerization and orchestration (Docker, Kubernetes) and infrastructure-as-code (Terraform)
• Experience with observability platforms and log analysis in production cloud environments
• Exposure to medical imaging data formats and pipelines

Salary Range: $140,000 - $170,000 Annually

The annual base salary range for this position based in the United States is noted. This range is an estimate, and actual salary may vary based on Magnus' compensation practices, job-related skills, depth of experience, relevant certifications and training, and geographic location. Magnus utilizes the full width of the range. Our compensation package also includes an annual bonus based on company goals and an equity grant.

Company Statement

We are deeply committed to integrity, kindness, and communication, and these principles govern how we will build our teams and operate the company. Magnus is an equal opportunity employer.  We value diversity and are committed to creating a positive, inclusive environment for all employees.