Biomedical Engineer

Lyka Smith specializes in the provision of medical equipment and devices, with a focus on offering advanced CAD/CAM products for surgical applications. Their services encompass a broad range of medical needs, including orthodontics, trauma response, reconstruction of mandibular cancer, and guided dental surgery. Since its establishment in 2017, Lyka Smith has manufactured over 5,000 custom, patient-specific components, supporting surgical procedures throughout Australia.
They are looking for an experienced Biomedical Engineer to join their team in Altona North in Victoria.
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The Role:
The position for hire is a Biomedical Engineer and will be for a full-time basis at $75,000 per annum, and will be based at their Altona North office.
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The Responsibilities:
Create innovative medical devices and equipment, such as orthodontic appliances, trauma fixation devices, and tools for mandibular cancer reconstruction, utilizing CAD/CAM technologies.
Tailor medical components to meet individual patient needs for surgeries, ensuring optimal fit and functionality.
Conduct rigorous testing and quality assurance processes to ensure that products meet safety standards and functional requirements.
Work closely with surgeons, dentists, and other healthcare professionals to understand clinical needs and develop effective solutions.
Ensure all products comply with relevant health regulations, standards, and ethical considerations, including TGA (Therapeutic Goods Administration) requirements in Australia.
Prepare detailed technical documentation, including design specifications, manufacturing processes, and user manuals for medical devices and equipment.
Offer training sessions and materials for healthcare professionals on the proper use and maintenance of new medical devices and technologies.
Analyse feedback from clinical use of devices to make iterative improvements and address any design flaws or functionality issues.
Develop prototypes for new devices or modifications to existing devices, testing for feasibility, usability, and performance in clinical settings.
Collaborate with suppliers and manufacturers to ensure the timely and cost-effective production of medical devices and components.
Lead projects from conception through to completion, managing timelines, resources, and team collaboration to achieve project goals.
Stay abreast of technological advancements in Biomedical Engineering and assess their potential application or integration into existing product lines, contributing to the company's innovative edge and competitiveness in the market.
Prepare patient data for virtual surgical planning.
Manufacture and perform finishing on internally designed medical devices.
Prepare and package medical devices and equipment for dispatch.
Booking and confirming courier services to hospitals and medical practices
Attending surgery to support surgeons and hospital staff with supplied products.
The Requirements:
Appropriate tertiary qualifications in Biomedical Engineering or related discipline
At least 3 years of Expertise or knowledge in computer-aided design (CAD) and computer-aided manufacturing (CAM) software specific to medical device and component design.
At least 3 years of experience in designing, developing, and testing medical devices, particularly in orthodontics, trauma fixation, mandibular reconstruction, or similar areas.
At least 3 years of experience and understanding of materials used in medical devices, including biocompatible materials and their properties.
At least 3 years of experience in quality assurance procedures, including testing and validation processes for medical devices.
Familiarity with medical device regulations and standards, such as those set by the Therapeutic Goods Administration (TGA) in Australia, and the ability to ensure compliance in all phases of device development.
Skills in prototyping, including the use of 3D printing technologies, to create and test device designs before mass production.
Strong analytical skills to assess design requirements and troubleshoot design issues during development and testing phases.
Capability to manage projects, including planning, execution, and monitoring, ensuring projects meet deadlines and budgets.
Ability to produce clear and detailed technical documentation for medical devices, including specifications, manufacturing instructions, and user guides.
Strong communication skills to effectively collaborate with multidisciplinary teams, including engineers, healthcare professionals, and manufacturing partners.
Understanding of ethical considerations in Biomedical Engineering, ensuring patient safety and privacy are prioritized in device design and testing.
Familiarity with software and tools used in medical device analysis, simulation, and design validation.