Design Engineer Role Overview
We are seeking a highly skilled Design Engineer to join our organization and contribute to the development of innovative medical devices.
Key Responsibilities:
* Translate customer feedback into actionable user needs.
* Develop concepts and prototypes for novel medical devices, utilizing design thinking principles and collaboration with cross-functional teams.
* Participate in design reviews, providing valuable insights to enhance product performance and manufacturability.
* Support manufacturing processes, including tooling, product design, and process validation, ensuring compliance with regulatory requirements.
* Analyze data sets using statistical techniques and generate reports to inform design decisions.
* Perform on-site laboratory testing and manage off-site testing labs, ensuring quality control and accuracy.
* Execute design controls activities, including design verification, validation, and transfer, maintaining regulatory compliance.
* Generate design verification/validation protocols and reports, detailing key findings and recommendations.
* Conduct risk management activities and create quality system and regulatory documentation, ensuring adherence to industry standards.