Lead Mechanical Engineer - Prototyping & Manufacturing
neo-bionica is a pioneering product development and contract manufacturing company specialising in neurotechnology, headquartered in Fitzroy, 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.
About the role
This is a full-time, on-site role for a Lead Mechanical Engineer - Prototyping & Manufacturing that leads mechanical engineering across prototyping, fabrication, and cleanroom manufacturing within a medical device CDMO, including implantable devices. This role combines hands-on engineering with supervision of technical staff and delivery of projects in a regulated environment.
Key Responsibilities
Produce engineering outputs including design documentation, drawings, specifications, and bills of materials
Contribute to risk management activities, including dFMEA and pFMEA
Design and develop prototypes, fixtures, tooling, and test equipment
Maintain documentation and support design control, verification, and validation
Support design transfer from prototype to controlled manufacturing
Make and justify technical decisions and trade-offs within assigned work packages
Plan engineering activities, manage technical timelines,



and report progress to project managers and clients
Oversee workshop, development lab, and cleanroom operations, including equipment maintenance and calibration
Supervise fabrication and cleanroom technicians; allocate work across projects
About you
Bachelor's degree in mechanical engineering or related discipline
10+ years' experience, including prototyping and/or low-volume manufacturing
Experience in a regulated environment (medical device preferred)
Proficiency in 3D CAD (e.g., SolidWorks)
Hands-on workshop fabrication experience (CNC milling, fixturing, etc.)
Experience supervising technical staff
Strong mechanical design and hands-on problem-solving
Effective leadership of technical staff
Explicit communication with clients and cross-functional teams
Balanced judgement across engineering, quality, and commercial considerations
About us
neo-bionica is a pioneering product development and contract manufacturing company specialising in neurotechnology, headquartered in Fitzroy, 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.
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📌 Lead Mechanical Engineer - Prototyping & Manufacturing (Melbourne)
🏢 NEO-BIONICA
📍 Melbourne