Mechanical Engineer - 6 Month Fixed Term Hire

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 is a commercial‑stage medical device company focused on developing treatments for chronic neurological conditions using its novel closed‑loop neuromodulation platform. The company’s proprietary technology senses and measures neural responses to stimulation and automatically adjusts therapy based on real‑time neurophysiological feedback.

At Saluda, we challenge boundaries. We innovate and think beyond the conventional. Our focus is to revolutionize the standard of care in neuromodulation to positively impact patient’s lives.

Reporting to the Head of Mechanical & Manufacturing Engineering, the primary role of this position is to support the mechanical engineering function within Saluda Medical. This includes mechanical, manufacturing and systems engineering.

Accountabilities And Associated Responsibilities

• Device Design and Optimization: Lead the design, development, and optimization of neuro-lead interfaces and implantable medical devices to meet project goals and timelines.
• Cross-functional Collaboration: Collaborate closely with R&D, engineering, and clinical teams to ensure alignment of designs with project objectives, incorporating feedback from clinical trials and user studies.
• Innovation and Integration: Drive innovation by incorporating advanced modeling techniques, staying informed about industry trends, and ensuring the seamless integration of electrical stimulation and modulation techniques into implantable devices.
• Utilize 3D modeling and rapid prototyping techniques 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

Essential Requirements

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