Description
We are in need of an engineer or scientist experienced in the development of instruments and software associated with the operation of IVD diagnostic tests running on automated systems.The employee's primary responsibilities will be in the laboratory. However, the employee will also review and edit project documentation (system test cases and reports). The candidate should be proficient in executing and documenting test results in a regulated environment. The person hired will focus on laboratory work associated with system and software feasibility testing, pre-validation system/software testing, analysis of results, and formal validation of systems under development.
Job Description:
- Ability to perform instrument/software/system feasibility and validation testing according to instructions from technical staff.
- Laboratory work experience in the medical device industry or in a laboratory using robotic instruments. Experience with testing instrument software and hardware.
- Familiarity with running clinical diagnostic instruments.
- Experience with PCR sample preparation and PCR experiments.
- Assists in system troubleshooting issues, and follow-up, as required.
- Performs ad-hoc testing on software releases during product development.
- Drafts and manages test case procedures. Also assists in the review of test case procedures.
- Executes test cases, records test results, and compiles associated documentation.
- Presents findings at group meetings, as required.
- Experience in or knowledge of assay development strongly desired.
To find out more about Real please visit www.realstaffing.com