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Jobs or company...

Sr. Mechanical Engineer

  • Full Time, onsite
  • TekOne IT Services Pvt. Ltd.
  • Pleasanton, United States of America
Salary undisclosed

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Role: Sr. Mechanical Engineer

Location: Pleasanton, CA

Duration: 12 Months

Summary

Design and test Class II/III mechanical circulatory support products (e.g., VADs, blood pumps, oxygenators). Solve complex problems, direct projects, and collaborate across teams.

Responsibilities
  • Design and test electromechanical devices for VAD and CPB applications.
  • Develop new products and improve existing ones through CAPA initiatives.
  • Establish product requirements and specifications.
  • Conduct design evaluations using experimental, empirical, and numerical analysis.
  • Investigate issues, identify root causes, and mitigate technical and program risks.
  • Create/review technical drawings for assembly and tolerancing.
  • Support Regulatory Affairs for FDA submissions and vendor evaluations.
  • Ensure compliance with FDA regulations and company policies.

Qualifications
  • B.S. in Mechanical, Biomedical, or Manufacturing Engineering.
  • 8+ years of engineering experience in product/process development and V&V for Class II/III medical devices.
  • Strong knowledge of FDA design controls (21 CFR 820.30).
  • Experience with CAD, SPC/Six Sigma, DOE, and project management.
  • Preferred: Experience in medical device manufacturing, EU MDR, ISO 13485, and relevant medical device standards.
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