Implantable Medical Device Mechanical Engineer - 6 Month FTC

Saluda Medical; Ryde; Hybrid; AUD 90,000 - 120,000; Full time

Job summary

Saluda Medical, a commercial‑stage medical device company, seeks a Mechanical Engineer for a 6-month fixed-term hire in Macquarie Park, NSW. You will lead design of neuro-lead interfaces and implantables, collaborate with R&D and clinical teams, and drive innovation with advanced modeling and rapid prototyping.

The role requires a mechanical engineering degree (or related) and 3 years of experience, with knowledge of FDA regulations (21 CFR 820.30) and IEC 60601-1.

Qualifications

• 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 IEC 60601-1

Responsibilities

• Lead the 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, incorporating feedback from trials and user studies.
• Drive innovation by incorporating advanced modeling techniques and staying informed about industry trends; integrate electrical stimulation and modulation 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 labeling would be an advantage

Skills

Electro-mechanical design

FDA regulations

IEC 60601-1

Education

Bachelor's degree in Mechanical Engineering

Bachelor's degree in Biomedical Engineering

Job description

Saluda Medical, a commercial‑stage medical device company, seeks a Mechanical Engineer for a 6-month fixed-term hire in Macquarie Park, NSW. You will lead design of neuro-lead interfaces and implantables, collaborate with R&D and clinical teams, and drive innovation with advanced modeling and rapid prototyping.

The role requires a mechanical engineering degree (or related) and 3 years of experience, with knowledge of FDA regulations (21 CFR 820.30) and IEC 60601-1.