Biomedical EngineerContract Role
No C2C
Onsite 4 days a week in Northbridge, CA
The employee will work as part of the in-vitro test team to:
*Help testing a new test system setup as replacement for a legacy unit
*Increase test capacity of the new system compared to the older system
* Integrate new test methods into the new procedure
*Help qualify the new test system and run test method validations.
Required skillsFamiliarity with CAD drawing, Familiarity with test methods and test system development. Experience in test method validation (Gage R&R, other MSA)
Technical SkillsSolid Works, Statistical Software (JMP, Minitab)
The WhyUnity commercial readiness and Tempe separation requires production space for solutions preparation.
As a result of this shift, this test system is heavily used for new design development testing as well troubleshooting and will need to be recreated at a different location while also increasing capacity as well as add additional features such as new testing methods.
At a high level:
- Developing and validating diagnostic assays and test systems
- Testing biomarkers to detect disease or monitor patient conditions
- Verifying the performance of instruments, reagents, sensors, and software
- Analytical testing-accuracy, precision, sensitivity, specificity, repeatability, etc.
- Design verification and validation (V&V) for medical device products
- Clinical or laboratory studies to demonstrate test performance
- Regulatory and quality compliance, including FDA, ISO, GMP, and design controls
- Troubleshooting test failures and investigating root cause
- Supporting the transition of products from R&D into manufacturing and commercialization
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