Overview
The Software Test Engineer will take on the pivotal role of managing verification and validation (V&V) for a medical device nearing FDA 510(k) approval. Collaborating closely with software, electronics, and quality teams, the contractor will independently execute testing to ensure the device meets its design requirements. This role is ideal for an experienced engineer who thrives in a self-directed environment and is passionate about contributing to the successful rollout of medical technology.
Responsibilities
- Develop detailed test specifications and sub-tests from high-level design requirements.
- Write, execute, and document test protocols for various testing levels including unit and integration.
- Instrument and run module-level and regression tests against embedded software.
- Provide feedback to the development team and facilitate issue resolution.
- Design test plans that comply with IEC 62304 standards.
Requirements
- Proven experience in verification and validation within an embedded software environment.
- Strong background in embedded programming, particularly in C/C++.
- Experience developing structured test cases and procedures from requirements.
- Familiarity with medical device regulations, specifically IEC 62304 and ISO 13485.
- Ability to script and understand the entire software engineering lifecycle.
- Comfortable working independently as the sole test engineer.