Senior Test and Design Assurance Engineer

Magnus Medical•Burlingame, CA

33d•$140,000 - $170,000•Hybrid

About The Position

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.

Requirements

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

Nice To Haves

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

Responsibilities

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
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
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