Mechanical Engineer - 6 Month Fixed Term Hire

Saluda Medical; Sydney; On-site; AUD 110,000 - 150,000; Full time

Job summary

Saluda Medical is seeking a mechanical/biomedical engineer to support the mechanical engineering function for neuro‑lead interfaces and implantable devices. The role involves design, development, and optimization to meet project goals while collaborating with R&D, engineering, and clinical teams.

Ideal candidates have a Bachelor’s in engineering, 3 years in electro‑mechanical device R&D, and familiarity with FDA 21 CFR 820.30 and IEC 60601-1.

Qualifications

• Degree in engineering (Mechanical or Biomedical) is required.
• 3 years’ experience in R&D for electro-mechanical implantable devices.
• Experience with FDA regulations (21 CFR 820.30) and IEC 60601-1 is preferred.
• Ability to work independently and within a multidisciplinary team.

Responsibilities

• Lead the design, development, and optimization of neuro-lead interfaces and implantable devices.
• Collaborate with R&D, engineering, and clinical teams to align designs with project objectives.
• Drive innovation by applying modeling techniques and integrating stimulation/modulation technologies.
• Utilize 3D modeling and rapid prototyping for early design iterations.
• Document designs for verification and validation activities.

Skills

Mechanical design

System engineering

3D modeling

Regulatory awareness

Education

Bachelor's degree in Mechanical or Biomedical Engineering

Tools

3D CAD software

Rapid prototyping

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 toestablishtechnical 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.