Vestech Medical Pty Ltd designs and manufactures medical devices. We are seeking a qualified Engineer with minimum 4 years professional experience, to complement our existing team. The successful applicant will need to have experience working in a medical device product development team, preferably in transferring the design into production.
Role will be require working with internal and external teams to create product specifications from customer requirements; perform dFMEAs and pFMEAs; develop verification and validation test protocols; and work with external suppliers to create quality plans and ensure design requirements are accurately translated into production specifications. Previous experience in developing electromechanical devices, with software (IEC 62304), as well as transferring product designs to overseas vendors, would be desirable.
- Create Product Requirements and Specifications from Customer Requirements
- 3D modelling and Engineering Drawings
- Validation and Verification Test Protocols and Reports
- Risk Management File – dFMEA and pFMEA
- Prepare documentation required for regulatory submission
- Liaise with external laboratories to conduct feasibility and V&V testing on prototypes
- Work with production vendor during the Design Transfer phase to transition the device from design and development into production.
- Create Device Master Records, such as Inspection Documentation, Work Instructions and Production Drawings
Required Skills and Knowledge
- Bachelor of Engineering Degree recognised by Engineers Australia, ideally Mechanical or Mechatronics
- Min 4 years’ experience in Medical Device Product Development
- CAD Experience (SolidEdge / Creo / Autodesk)
- Creation of Design History Files, such as Design Inputs, Risk Management Documents and V&V protocols and reports.
- Knowledge of AS 1100 and GD&T
- Experience with injection moulding, CNC machining and assembly processes
- Able to work independently and with multiple external stakeholders, including overseas vendors
- Excellent verbal and report writing skills
- Knowledge of ISO 13485:2016 and especially Design Controls
- Customer/client facing skills and presentation are highly advantageous