Biomedical Engineer

Biomedical Engineer
Contract 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 skills
Familiarity with CAD drawing, Familiarity with test methods and test system development. Experience in test method validation (Gage R&R, other MSA)
Technical Skills
Solid Works, Statistical Software (JMP, Minitab)
The Why
Unity 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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