New Product Engineer

On Q Recruitment; Melbourne; On-site; AUD 85,000 - 120,000; Full time

Job summary

On Q Recruitment represents an Australian medical technology company in Melbourne seeking a Mechanical/Mechatronic Engineer with 2+ years in medical devices. You will design for manufacture and test, transfer designs to production, and support market launch.

Proficiency in SolidWorks and risk management is essential, with exposure to V&V and ISO quality systems. Collaborating with engineering, production, and operations teams, you will drive process improvements, supplier evaluation, and

Qualifications

• Bachelor’s degree in mechanical or mechatronic engineering with 2+ years in medical devices or a highly regulated industry.
• Hands-on manufacturing transfer skills and high proficiency in SolidWorks.
• Experience with Design for Manufacture (DfM) and Design for Assembly (DfA).
• Involvement in risk management, prototyping, verification and validation (V&V).
• Knowledge of regulatory requirements (FDA) and ISO13485/ISO9001 is highly regarded.
• Clear communication and strong technical writing; cross-functional collaboration.

Responsibilities

• Assist with design of new devices and transfer of designs into production.
• Evaluate and select suppliers; develop safe, efficient manufacturing processes.
• Prepare documentation and conduct process qualifications.
• Support manufacturing transfer, commercialization activities and market launch.

Job description

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

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.