Lead Mechanical Engineer - Prototyping & Manufacturing

Neo-Bionica Pty Ltd; City of Melbourne; On-site; AUD 150,000 - 190,000; Full time

Job summary

neo-bionica, headquartered in Fitzroy, Australia, is seeking a Lead Mechanical Engineer to lead prototyping and manufacturing for implantable devices in a regulated medical device CDMO. This full-time on-site role combines hands-on engineering with supervision of technical staff and project delivery.

The ideal candidate has 10+ years in prototyping or low-volume manufacturing, strong CAD skills (SolidWorks), and proven leadership across engineering teams in regulated environments.

Qualifications

• Bachelor's degree in mechanical engineering or related discipline.
• 10+ years' experience in prototyping and/or small-batch manufacturing.
• Experience in a regulated environment (medical device preferred).
• Proficiency in 3D CAD (SolidWorks).
• Hands-on workshop fabrication experience (CNC milling, fixturing).
• Experience supervising technical staff.
• Strong mechanical design and hands-on problem-solving.
• Clear communication with clients and cross-functional teams.
• Balanced judgement across engineering, quality, and commercial considerations.

Responsibilities

• Produce engineering outputs including design docs, drawings, specs, and BOMs.
• Contribute to risk management activities (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 work packages.
• Plan activities, manage timelines, and report progress to project managers and clients.
• Oversee workshop, development lab, and cleanroom operations; calibrate equipment.
• Supervise fabrication and cleanroom technicians; allocate work across projects.

Skills

Leadership

Team supervision

Client communication

Project planning

Regulatory awareness

Mechanical design

Education

Bachelor's degree in mechanical engineering

Tools

SolidWorks

CNC milling

Fixturing

Job description

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
• Clear 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.