Senior Mechanical/Biomedical Engineer

3 weeks ago

Pleasanton, United States Intellectt Inc Full time

Senior Mechanical/Biomedical Engineer Location: Pleasanton, CA Duration: 12 Months on W2 Shift: 8 AM–5 PM We are seeking an experienced engineer to support testing, development, and sustaining of Class II/III electromechanical medical devices (VADs, blood pumps, oxygenators). The role includes design analysis, V&V testing, CAPA‑driven improvements, risk assessment, and ensuring FDA/ISO compliance. Requirements B.S. in Mechanical/Biomedical/Manufacturing Engineering 8+ years in medical device engineering (V&V, product/process development, risk management) Strong FDA design controls knowledge (21 CFR 820.30) CAD, GD&T, tolerance analysis, and cross‑functional collaboration skills Preferred Experience with VADs or implantable devices, high‑volume manufacturing, ISO 13485/EU MDR, Six Sigma/DOE. Seniority Level Mid‑Senior level Employment Type Contract Job Function Manufacturing Industries Medical Equipment Manufacturing, Biotechnology Research, and Pharmaceutical Manufacturing #J-18808-Ljbffr

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    3 weeks ago

    Pleasanton, United States LVI Associates Full time

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  • Senior Mechanical Engineer

    3 weeks ago

    Pleasanton, United States LVI Associates Full time

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    Pleasanton, United States LVI Associates Full time

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    Pleasanton, United States LVI Associates Full time

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    Pleasanton, United States Digital Prospectors Full time

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    Pleasanton, United States SoloPoint Solutions Full time

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    Pleasanton, California, United States Generis Tek Inc Full time $120,000 - $160,000 per year

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    Pleasanton, United States Spectraforce Technologies Full time

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    Pleasanton, United States Actalent Full time

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    3 weeks ago

    Pleasanton, CA, United States LVI Associates Full time

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