Electrical Hardware Sustainer
The Electrical Hardware Sustainer will oversee multiple complex engineering projects with high business impact and work in a global cross-functional environment.
Responsibilities:
* Drive continuous improvement and value engineering initiatives on released hardware products by analyzing performance metrics and implementing process enhancements.
* Develop, review, and execute electrical electronic and mechanical design updates due to component obsolescence or value engineering proposals including testing and validation.
* Prevent and respond to production stoppages due to supplier design or quality-related matters ensuring compliance with quality standards.
* Write coordinate and implement engineering change orders to meet regulatory requirements.
* Identify potential hazards and maintain risk management files for medical devices.
* Design test methods and engineering studies to validate product performance and functionality.
* Conduct create review and execute engineering studies characterization assessments and verification test protocols/reports ensuring compliance with FDA design controls.
* Lead and execute experimental feasibility tests to evaluate product performance and identify areas for improvement.
* Support qualification of new products processes and testing ensuring compliance with regulatory requirements.
* Deliver medical device design documentation compliant with good documentation practices.
* Conduct safety testing and maintenance of product compliance with applicable standards and regulatory requirements.
* Investigate resolve and report corrective and preventative actions using problem-solving techniques.