Design Engineer Role
This is a key position in our engineering core team with exposure across various functions. As Design Engineer, you will be responsible for translating customer and patient information into user needs, developing novel medical device concepts and prototypes, contributing to design reviews, providing insights to optimise product performance, supporting manufacturing of new products, analysing data sets using statistical techniques, generating reports to summarise information, managing off-site testing labs, executing design controls activities, conducting risk management activities, and creating quality system and regulatory documentation.
Job Responsibilities
* Develop innovative medical devices through research and concept development
* Collaborate with cross-functional teams to drive product development
* Analyse data sets and generate reports to inform decision-making
* Ensure compliance with ISO 13485 & FDA 21 CFR Part 820 regulations
* Conduct risk management activities and create quality system documentation
Requirements
* Bachelor of Science in Engineering or related field with 5+ years' experience in medical device development
* Proven track record in design and development of medical devices per ISO 13485 & FDA 21 CFR Part 820
* Familiarity with medical device regulations (MDR and FDA) and ISO 14971/I EC 62366 standards