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Title: Software V&V Engineer
Hiring Organization: Connexion Systems & Engineering
Compensation, Benefits, and Employment Type
- Duration – Contract
- Pay rate: $35-37/hr.
- Job Location: San Diego, CA
- Job# bh12429
SW V & V Engineer
- Prefers green candidates | 1-3 years, BS in Biomedical, Bioinformatics, Chemical or Electrical Engineering would work. Some experience with R&D Systems testing is required. Does not require med device experience.
- Requires med device.
- All candidates must have some level of R&D experience.
We are currently seeking a Software Verification and Validation Engineer who will be responsible for testing software for highly complex medical devices/instrumentation for IVD Product Development and IVD Product Testing.
Essential Duties and Responsibilities
- The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs.
- Design and development of test protocols for new and advanced features.
- Apply experience with black box testing to plan, write test cases, test reports, and test software and hardware requirements for a Class II Medical Device.
- Perform Verification and Validation testing in an FDA/UL regulated environment.
- Assist with all aspects of medical device life cycle process, IEC 62304.
- Troubleshoot product problems, improvements or field complaints.
- Assist with root cause analysis.
- Perform laboratory work to assure completion in accordance with established safety procedures and applicable regulatory regulations.
- Ensure software validation procedures and guidelines are maintained and kept current with FDA guidelines.
- Work with molecular diagnostic technology and nucleic acid amplification.
- Assist with tools validation.
- At least one year of software testing experience.
- Will accept any suitable combination of education, training, and/or experience.
- Experience with one or more of the following is preferred:
1. FDA/UL software validation guidelines;
2. Complex instrumentation platform;
3. Evaluation methods in the design, development and debugging of SW programs;
4. IVD Product Development and IVD Product Testing;
5. Molecular diagnostic technology and nucleic acid amplification;
6. Medical device software life cycle process, IEC 62304;
7. Writing technical test protocols and technical reports; and
8. Black box testing.
- Candidate must be physically capable and willing to work in a lab environment 6-7 hours/day performing system level manual testing on a complex instrumentation platform.
- Candidate will be required to work 2 PM -11pm shift based on project needs.
Candidate will be required to work in either the Saturday-Wednesday or Tuesday -Saturday work week based on project needs.
Please use the apply button to submit your resume for consideration. A Connexion Representative will contact you immediately.
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