Medical Device Design Engineer

Katalyst Healthcares & Life Sciences • Irvine, CA, US • 1w ago

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.
Active 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.
Assist 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.

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