New Product Engineer

Our client is an Australian based medical technology company developing innovative imaging technology with multiple clinical applications which enhances patient outcomes.

As a New Product Engineer in medical devices - we want to see your passion for delivering commercialized products that improve efficiencies and patient outcomes; we want to see your love for working cross functionally and your amazing problem-solving skills.

Opportunity

The purpose of this role is to assist with the design of new devices and the transfer of existing designs into production. The successful candidate, will be responsible for evaluating and selecting suppliers, developing safe and efficient manufacturing processes, preparing documentation, and performing process qualifications. The key focus will be modifying designs for Manufacture (DfX), and Design for Test (DFT), manufacturing transfer, and commercialization activities to enable products to move from development into production and then to market launch.

About You

You will hold a Bachelor’s degree as a mechanical engineer or mechatronic engineer with at least 2 years’ experience or more in medical devices or a highly regulated industry. You need to have hands-on manufacturing transfer skills, and a high level of proficiency in SolidWorks. You will need to be confident in assisting device design, risk management, prototyping, and verification and validation. Experience in DfM is essential, and DfA - design for assembly. You will have a process improvement mindset and be capable of doing root cause analysis and identifying solutions. Any regulatory and/or FDA knowledge will be highly regarded, and prior experience with ISO13485 and ISO9001 ideal. It is a cross functional role, and you will work closely with the engineering, production, and operational teams, so clear communication skills and technical writing skills are essential.

This is an exciting opportunity to work closely with an experienced team, where you can expect excellent career growth and the opportunity to add value and take responsibility for your own projects.