Irvine CA
Job Description:
>> Lead Continuous Improvement (CIP) projects by collaborating with internal teams and external suppliers.
>> Perform CIP calculations, including evaluation of supplier quotations.
>> Develop and finalize project budgets, incorporating feasibility assessments, capital equipment needs, validation costs, DVT sample requirements, and other testing factors.
>> Create detailed project plans in Microsoft Project and prepare supporting documentation slide decks in PowerPoint.
>> Demonstrate strong understanding of product electrical design, architecture, and system functionalities.
>> Lead design changes, component substitutions, or supplier transitions to deliver cost savings and improved performance (Type II savings).
>> Develop innovative and strategic approaches to achieve CIP targets.
>> Perform engineering testing, prepare test protocols, write test reports, and conduct design reviews.
>> Provide comprehensive oversight of project tasks, timelines, dependencies, and execution strategies.
>> Identify appropriate electrical test methods and align requirements with RD partners.
>> Review requirements, support process validation, and finalize relevant documentation (e.g., RR forms, validation reports).
>> Execute change requests and supplier change control processes.
>> Communicate business related issues or opportunities to the next level of management.
>> Ensure compliance with all Health, Safety, Environmental, and regulatory guidelines ensure resource readiness.
>> Ensure personal and team compliance with all Federal, State, Local, and Company regulations and procedures.
>> May supervise or provide technical direction to junior electrical engineers or technicians.
>> Perform other duties as assigned.
Requirements:
>> Experience in Medical Device & Regulations
>> Product Support - Product Engineering
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