Mechanical Engineer Organisation Context The Bionics Institute is a world leader in the development of medical devices for the treatment of otherwise intractable conditions. The Bionics Institute is in an exciting phase, developing therapeutic technology for hearing loss, Parkinson’s disease and inflammatory bowel disease and unique methods for the improved diagnosis of epilepsy, movement disorders and deafness. Position Summary As a Mechanical Engineer, the incumbent is required to work as part of inter-disciplinary teams developing medical devices. This position will be contributing towards the design, testing, and development of neuro-modulation systems, neural-interfacing electrodes and implantable leads. Additionally, developing IP and requirements, interfacing with clinicians, project teams and stakeholders to achieve project and corporate goals. The position involves close collaboration with investigators across different projects underway at the Bionics Institute. The incumbent is expected to be highly motivated and exhibit a high level of communication skills. The incumbent is expected to contribute to the development of new technologies and more broadly to the effective operation and success of the Bionics Institute. This position reports to Owen Burns (Program Manager). Goals of this Position Support development activities for neuro-modulations systems as they progress through the pipeline from conception, pre-clinical development, early product design, manufacture and clinical application Develop specific mechanical design solutions for implantable and wearable neuro-modulation systems Key Responsibilities Generate intellectual property (IP) Design biocompatible neuro interfacing systems Define requirements and designs for the mechanical components for neuro-modulation implantable medical devices Deliver detailed documentation of the device design (BOM, drawings, …) compliant with design control requirements Design and build experimental setups necessary to perform bench, characterisation and in vivo testing, integration, system testing Design for reliability, manufacturing, and testing, including concept engineering, functional analysis, stress analysis and mechanical modelling Work with clinicians to capture, evolve and implement requirements and designs suitable for early product development in pre-clinical and clinical applications Interface with other engineering disciplines (EE, SW, ME), scientists and technical staff to ensure mechanical designs are compatible with electronics, data transmission, signal processing requirements and fit for defined use cases Define test plans to verify safety and mechanical performance of designs in compliance with applicable standards, (e.g. ISO9001, ISO13485, etc.) and project requirements Design and implement mechanical designs for: Implantable leads (electrode arrays) Connectors, connecting implantable leads to neuro-modulations systems Mechanical components of implantable and external neuro-modulations systems Integration with surgical practices and design of custom surgical tooling Providing general engineering support for preclinical and clinical activities Provide technical and mentoring support to BI staff and students as and when required Make original contributions to scientific manuscripts for publication and scientific seminars on the research and development performed Organise and maintain design history files, laboratory notebooks and other data capture systems in according to Bionics Institute guidelines, project needs and regulatory requirements Supervise technical staff and students as appropriate Communicate effectively with researchers, clinicians and management staff Attend and contribute to meetings associated with relevant projects Key Selection Criteria – What is needed for success Knowledge, skills and experience A mechanical engineer with work experience in developing implantable leads/interfaces and having a strong understanding of implantable medical device development Demonstrated skills in areas required to perform this role: Mechanical designs using 2D/3D CAD, and FEM modelling Selection of medical-grade materials and components Safety and performance testing for project / regulatory requirements Tertiary qualifications or equivalent experience in mechanical / biomedical engineering Experience in an inter-disciplinary environment Experience in mechanical design Medical device prototyping and/or manufacturing Experience in preclinical, translational or clinical research and development Personal qualities Results Focused Logical, creative, and innovative thinking Strong communication and presentation skills Ability to work autonomously and push the initiative Strong hands-on skills, experience in rapid prototyping methods and machine shop tools Team oriented, a sparring partner to colleagues in other disciplines of the medical device industry Fast learner, high energy, self-motivated and pro-active individual able to work in a fast-moving environment Role Classification Descriptors Task Complexity Complex: Work requires the position holder to apply their comprehensive knowledge to tasks and activities. At this level, specialist or in-depth knowledge of operations will be required. Knowledge Broad: Substantial theoretical, policy or technical knowledge, may require some knowledge of external environment (for example – relevant ISO standards for medical devices). Judgement / Problem Solving Interpretative: Uses own judgement to solve problems in own work area. Should apply own skills and knowledge to assess best approach to a work task or problem. At this level, position holder is expected to show initiative to recommend and apply work process improvements. Has latitude to decide on work scheduling and priorities and can exercise own judgement over when to refer a matter to a higher level. Level of Supervision, Autonomy Broad: Position holder is told at a high-level what outcomes need to be achieved by the team, when they need to be completed and who needs to be involved in achieving them. Position holder participates in decision-making and operates within the broad framework of organisational policies and procedures. Monthly supervision – broad outcomes are reviewed. Organisational Relationships and Impacts Strong: Position holder is able to apply their knowledge of their work area and understand the impact of their actions on other work areas and employees. Should provide advice or assistance to others based on in-depth knowledge within field of expertise. Can and should recommend changes to processes and procedures to improve operations. Download the full job description. Further Information For further information about the research project, please contact the Program Manager, Owen Burns, by email: [email protected]titute.org. How to apply Submit your application by clicking ‘Apply for Job’ via SEEK. Please include a brief cover letter that addresses the selection criteria. This is a fixed-term contract to 31 December 2024 with the possibility to renew (contingent on funding). Applications close on Friday 09 July. The Bionics Institute is an independent medical research institute affiliated with The University of Melbourne, and is dedicated to translating into clinics life-enhancing treatments for neurological and sensory disorders. The Bionics Institute is an equal opportunity employer and female applicants are encouraged to apply. The Institute maintains a smoke free workplace and a workplace free from sexual harassment. The Bionics Institute’s workplace embraces the Occupational Health and Safety Standards.