Medical Device Design Engineer Job at Katalyst HealthCares and Life Sciences, Irvine, CA

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  • Katalyst HealthCares and Life Sciences
  • Irvine, CA

Job Description

Roles & Responsibilities:

  • Under limited supervision and in accordance with all applicable federal, state and local laws, regulations and procedures and guidelines, the duties and responsibilities for this position are:
  • Lead and drive execution of design of medical devices and components in compliance with applicable standards.
  • Prepare concept designs.
  • ctive involvement in CAD related support activities.
  • Perform design feasibility study.
  • Prepare technical reports, risk assessments and support design reviews.
  • Ensure design meets regulatory requirements and follow design control processes.
  • Support prototype development and testing, TMD, TMV and Fixture design.
  • Perform Verification Validation activities.
  • Investigate design issues, analyse failures if any, and implement corrective actions.
  • ssist in statistical analysis and design of experiments.
  • Contribute to project planning, timeliness and deliverables.
  • Collaborate with cross-functional team environment.
  • Medical Device & Regulations.
  • New Product Development (NPD) Methodology and Management.
  • Strong project planning and execution skills.
  • Stakeholder and risk management.

Job Tags

Full time, Local area,

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