Mechanical Engineer, Implantable Medical Devices

Saluda Medical; Sydney; On-site; AUD 80,000 - 120,000; Full time

Job summary

Saluda Medical in Sydney is seeking a mechanical/biomedical engineer to support the mechanical engineering function, including design, development and optimization of neuro-lead interfaces and implantable medical devices.

You will collaborate with R&D, engineering and clinical teams, apply 3D modeling and rapid prototyping, document designs for Verification and Validation, and contribute to regulatory filings.

Qualifications

• Bachelor's degree in mechanical, biomedical engineering or related field.
• 3 years’ experience in mechanical/biomedical design or implantable devices.
• Experience with FDA regulations (21 CFR 820.30) and IEC 60601-1.
• Experience in R&D activities related to electro-mechanical implantable medical devices.
• Self-starter with ability to work independently and collaboratively in a multidisciplinary environment.

Responsibilities

• Lead design, development, and optimization of neuro-lead interfaces and implantable medical devices to meet project goals and timelines.
• Collaborate closely with R&D, engineering, and clinical teams to ensure alignment of designs with project objectives.
• Drive innovation by incorporating advanced modeling techniques and integration of electrical stimulation into implantable devices.
• Utilize 3D modeling and rapid prototyping for early design iterations.
• Document designs thoroughly for verification and validation activities.
• Lead sub-projects and collaborate with external manufacturing teams for design transfer and production optimization.
• Compile and analyze operational data to establish technical specifications and ensure compliance with industry standards.
• Develop device history files including requirements, risk management, and usability files.
• Support regulatory filings and intellectual property development.
• Prior experience with labelling would be an advantage

Skills

3 years’ experience

Self-starter

Collaborative

Regulatory awareness

Education

Bachelor's degree in Mechanical Engineering, Biomedical Engineering or related field

Job description

Saluda Medical in Sydney is seeking a mechanical/biomedical engineer to support the mechanical engineering function, including design, development and optimization of neuro-lead interfaces and implantable medical devices.

You will collaborate with R&D, engineering and clinical teams, apply 3D modeling and rapid prototyping, document designs for Verification and Validation, and contribute to regulatory filings.