Design Engineer Opportunity
As a Design Engineer, you will play a pivotal role in the development of novel medical devices for the global market.
* Translate customer and patient information into user needs.
* Develop concepts (CAD) and prototypes (3D print) of new medical devices.
* Contribute to design reviews and offer insights to optimize product performance and manufacturability.
* Support manufacturing with tooling, product design, and process validation.
* Analyze data sets and generate reports summarizing the information.
* Manage on-site and off-site testing labs and test houses required for external testing.
* Execute design controls activities per FDA 21 CFR Part 820.
Requirements
Key Qualifications:
* Bachelor of Science in Engineering or Mechanical Engineering/Biomedical with 5+ years' experience in a medical device company.
* Experience in design and development of medical devices per ISO 13485 & FDA 21 CFR Part 820.
* Knowledge of medical device regulations (MDR and FDA) and experience with ISO 14971 and IEC 62366 is an advantage.