Senior Test & Design Assurance Engineer - Regulated SaMD

Magnus Medical; Burlingame (CA); Hybrid; USD 140,000 - 170,000; Full time

Benefits offered by this job

Annual bonus

Equity grant

Hybrid work arrangement

Job summary

Magnus Medical, based in Burlingame, CA, seeks a Senior Test and Design Assurance Engineer to own product releases and drive V&V strategy in a hybrid work environment. The role collaborates with developers, QA, regulatory, and clinical teams to ensure compliant releases of Magnus Cloud and SaMD software.

You will lead test plans, maintain risk management files, and support FDA submissions while contributing to a cross-functional, fast-paced R&D culture.

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

Responsibilities

• Own product releases and define test strategy; create documentation for releases in a regulated environment.
• Maintain risk management inputs and design history file evidence, aligning with QA for regulatory submissions.
• Define, review, and coordinate executing test plans and protocols across teams.
• Lead V&V strategy for releases; develop automated and manual test suites.
• Coordinate release readiness across development, quality, regulatory, product, clinical, and commercial teams.
• Support audits and regulatory submissions; ensure documentation compliance.

Skills

V&V strategy

Test automation

Regulatory submissions/audits

Git & Jira

Independent technical direction

Cross-functional collaboration

Medical device software testing

Education

Bachelor's degree in CS/Engineering or equivalent

Tools

Git

Jira

CI/CD tooling

Docker

Kubernetes

Job description

Magnus Medical, based in Burlingame, CA, seeks a Senior Test and Design Assurance Engineer to own product releases and drive V&V strategy in a hybrid work environment. The role collaborates with developers, QA, regulatory, and clinical teams to ensure compliant releases of Magnus Cloud and SaMD software.

You will lead test plans, maintain risk management files, and support FDA submissions while contributing to a cross-functional, fast-paced R&D culture.