uWorkin

System Engineer
My client is based in Sydney, New South Wales, Australia

They are looking for a System Engineer. The ideal candidate will serve as a primary engineer responsible for the management of cross-functional activities within the Product Development Group. The role reports directly to Senior Management and is responsible for managing engineering, scientific and product development activities to help drive patient-centric design, development, and manufacture of products. The roles is also responsible for ensuring these activities are undertaken in compliance with the Company's quality management system and other applicable regulatory requirements.

Qualifications
* Completed a degree in Mechanical engineering, Biomedical engineering, or other relevant disciplines

Experience
* 3 years or more in an Orthopedic Medical Device product development experience
* Proficiency in specification development and CAD-modelling for medical devices
* Experience working in a medical device regulated environment.

Major Responsibilities

Facilitation of medical device product development projects
* Facilitating interactions between the product development team, suppliers, and related groups within the Company
* Participating in the fulfilment of design requirements through working as a core member of the cross-functional team
* Creation of drawings and CAD models of the product during design and development activities
* Participating in the drafting of validation and verification testing protocols during the phase of product development.
* Developing and delivering technical documentation during product development
* Ensuring that technical documentation meets quality and regulatory requirements for regulated medical devices.
* Ability to comprehend large amounts of scientific content, which is then communicated in a clear, concise fashion
* Assimilate new concepts and information to deliver positive and innovative solutions.
* All other activities deemed necessary for medical device product development

Project Management
* Lead projects from planning through to completion, in alignment with the Company's strategic objectives
* Manage cross-functional teams involved in medical device product development projects
* Manage suppliers and contractors involved in medical device product development projects
* Demonstrate success in self-managing priorities and multi-tasking projects
* Develop, track, and interpret project key performance indicators and metrics to ensure the ongoing sustainability of the Company

Compliance to Quality Assurance
* Ensure the project activities are carried out in line with the Company's procedures and external regulations
* Communicate and ensure that the QA procedures are understood and adhered to by all employees and contractors working on the medical device product development projects
* Work with Quality and Business Operations Manager to identify opportunities to improve the quality and efficiency of our products and services