Lead Mechanical Engineer - Prototyping & Manufacturing …, City of Yarra

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. Role Description 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
- Provide technical input into scoping, estimation, and change control Fabrication & Cleanroom Operations
- Oversee workshop, development lab, and cleanroom operations, including equipment maintenance and calibration
- Maintain controlled processes, SOPs, and work instructions for fabrication activities Health, Safety & Setting
- Promote and ensure safe work practises and operation of workshop and cleanroom environments
- Conduct and support risk assessments for equipment and processes
- Manage compliance with workplace health and safety requirements
- Supervise fabrication and cleanroom technicians; allocate work across projects
- Provide technical direction, training, and performance management Core Competencies
- 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
- Working knowledge of ISO 13485 and ISO 14971
- Cleanroom experience (ISO Class 7 / 8 or equivalent)
- Design transfer and process validation experience
- Strong mechanical design and hands‑on problem‑solving
- Effective leadership of technical staff
- Clear communication with clients and cross‑functional teams
- Balanced judgement across engineering, quality, and commercial considerations
- Planning across concurrent projects and workshop priorities #J-18808-Ljbffr Apply on Kit Job: kitjobau.com/job/3q75y4