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Neo-Bionica is a pioneering product development and contract manufacturing company specialising in neurotechnology, headquartered in Australia. Our mission is to partner in developing cutting-edge medical devices that improve the quality of life for individuals with neurological conditions. We are committed to innovation, excellence, and transforming healthcare through advanced technology.
Position Summary:
This role plays a key role in designing, developing, and transferring Class III and AIMD neurotechnology medical devices. This hands-on role requires expertise in mechanical engineering, systems integration, DFM, risk management, and regulatory compliance. The candidate will lead projects from concept to manufacturing, mentor junior engineers, and collaborate cross-functionally to optimize development processes.
Key Responsibilities:
* Lead mechanical and systems engineering activities from concept to design transfer.
* Collaborate with cross-functional teams (electrical, software, regulatory, manufacturing) to define system requirements and ensure seamless integration.
* Design mechanical components and systems compliant with Class III medical device regulations with DFM, DTC, and DFA considerations.
* Conduct design reviews, risk management (FMEA, ISO 14971), and verification/validation (V&V) with related documentation.
* Prototype, test, and validate mechanical systems in a regulated environment.
* Mentor junior engineers and support cleanroom practices.
Core Competencies:
* Education & Experience: Bachelor’s in Mechanical, Biomedical, or Mechatronics Engineering (or equivalent), with 5-7 years in mechanical/systems engineering, preferably in Neurotech or Class III devices.
* Technical Expertise: CAD (SolidWorks, Fusion 360), prototyping, cleanroom manufacturing, DFM/DFA/DTC, risk management (ISO 14971), fixture/tooling design, and design transfer.
* Teamwork & Leadership: Strong collaboration, project ownership, mentoring ability, and stakeholder communication.
* Knowledge of ISO 13485, ISO 14971, FDA regulations.
* Experience with implantable leads or minimally invasive devices.
* Experience with PLM, FEA, CFD (ANSYS, Cosmos).
This role requires a proactive, hands-on engineer who thrives in a collaborative environment and is committed to delivering high-quality medical devices.
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