Medical Device Design and Development Expertise:
The ideal candidate will possess significant expertise in medical device design and development, including experience with SolidWorks, prototyping, testing, and execution of validation protocols and reports. A Mechanical or Biomedical Engineering degree and at least 4 years' experience in the field are required. Collaboration with cross-functional project teams and suppliers is essential for success in this role.
Responsibilities:
* Develop and implement robust product designs that meet regulatory requirements.
* Collaborate with cross-functional teams to ensure effective communication and coordination.
* Work with suppliers to source and validate high-quality components and materials.
* Develop and execute comprehensive validation plans to ensure compliance with regulatory requirements.
* Continuously improve processes and procedures to enhance efficiency and effectiveness.