Senior Test & Design Assurance Engineer - Medical Devices

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

Job summary

Magnus Medical, Inc. in Burlingame, CA, is seeking a Senior Test and Design Assurance Engineer to own product releases and drive V&V in a regulated SaMD environment.

You will define test strategy, review tests, craft release documentation, and collaborate with development, QA, and regulatory teams in a hybrid work setting. You will maintain risk management, requirements traceability, and the design history file to support regulatory submissions, audits, and filings, with significant autonomy and

Qualifications

• Degree in computer science, engineering, or related technical field or equivalent practical experience.
• 5+ years of software verification and validation experience, including 3+ years in a regulated medical device environment.
• Experience with IEC 62304, ISO 14971 and design controls; ability to author regulatory documentation.
• Experience with version control and issue tracking systems (Git, Jira).
• Ownership of V&V strategy for a regulated software product.

Responsibilities

• Own the V&V strategy and release planning for software products.
• Define, review, and coordinate test plans and protocols.
• Develop and review tests; maintain test documentation for regulatory submissions.
• Maintain risk management inputs and requirements traceability (RAT/FH).
• Lead collaboration with development, QA, regulatory, clinical, and commercial teams.
• Hybrid work arrangement based in Burlingame, CA with regular onsite releases.

Skills

Software verification

Software validation

Regulated environment

Git

Jira

V&V strategy

Test automation

CI/CD

Docker

Kubernetes

Terraform

AWS

REST APIs

Cloud testing

Observability

Imaging data

Education

Bachelor's degree in CS/Engineering

Tools

Git

Jira

Job description

Magnus Medical, Inc. in Burlingame, CA, is seeking a Senior Test and Design Assurance Engineer to own product releases and drive V&V in a regulated SaMD environment.

You will define test strategy, review tests, craft release documentation, and collaborate with development, QA, and regulatory teams in a hybrid work setting. You will maintain risk management, requirements traceability, and the design history file to support regulatory submissions, audits, and filings, with significant autonomy and