Medical Device Software Quality Engineer (Technical)
San Francisco, CA
Medical Device Software Validation Engineer (Technical)
Our client is a large medical device manufacturer. The client is currently in need of a Software Validation consultant, with technical expertise, to support a few efforts across their organization.
Principle Duties and Responsibilities:
The consultant will come from a medical device background with strong hands-on experience in Software Validation, specifically technical support in the areas of C++ testing and Labview. Some of the efforts this person will be working on are related to the integration of an existing business unit as well as one that was acquired recently. Integration activities may involved software validation for embedded product software as well as manufacturing equipment software. Some of this role' s efforts will include product/software testing to prepare the client for product qualification. This person should also be able to write and review test scripts. This person should be comfortable with the full life-cycle of Software Validation and Computer Software Validation for Medical Device manufacturing. This person will be required to participate and contribute in activity on the technical side of things, so experience with C++ testing is required.
It is crucial that the consultant is comfortable in a fast paced remediation environment where scope and duties can change from time to time. The consultant should possess extreme attention to detail.
- Medical Device 7+ years
- Extensive Software Validation experience
- Labiew experience
- C++ testing
- 21 CFR Part 820
- 21 CFR Part 11
Job Type: Contract