Medical Device Design Expert
The ideal candidate will be a seasoned design engineer with expertise in developing novel medical devices for the global market.
The Role:
* Translate customer and patient needs into user requirements.
* Develop concepts and prototypes of medical devices using CAD and 3D printing.
* Contribute to design reviews, providing valuable insights to optimise product performance and manufacturability.
* Support manufacturing of new products with tooling, product design, and process validation.
* Analyse data sets using statistical techniques and generate reports to summarise the information.
* Responsible for on-site laboratory testing and managing off-site testing labs and test houses.
Responsibilities:
* Execute design controls activities, including design verification, validation, and transfer per FDA 21 CFR Part 820.
* Generate design verification/validation protocols and reports.
* Conduct risk management activities per ISO 14971.
* Responsible for creation of quality system and regulatory documentation.
Requirements:
* Bachelor of Science in Engineering or related field.
* 5+ years experience working for a medical device company whose products and processes are FDA/EU regulated.
* Experience in design and development of medical devices per ISO 13485 & FDA 21 CFR Part 820, especially design verification and validation.
* Knowledge of medical device regulations (MDR and FDA) and experience with ISO 14971 and IEC 62366 is an advantage.
We're Looking for a Skilled Design Engineer
To join our team as a Medical Device Design Expert. If you have the required skills and qualifications, we'd love to hear from you.