Systems Engineer Medical Device jobs

About Saluda Medical

Saluda Medical was founded in 2013 for the purpose of transforming patients’ lives with disruptive neuromodulation solutions. We are leaders in the field with proven exceptional pain management results and, with more than 10 years of advanced research development and clinical experience, we design and develop advanced neuromodulation systems for the next generation of implantable stimulation devices.

About the role

We are seeking a Clinical Engineer to liaise with a team of software, electrical, mechanical, signal processing, research and field clinical engineers to assist in guiding the introduction of technology that leads to clinically relevant patient outcomes and ensures that the system meets clinical requirements.

This role is located in Macquarie Park.

What you will do

• Lead the definition and validation of user and functional requirements for Saluda Medical products, ensuring alignment with clinical needs, regulatory expectations, and long‑term product strategy.
• Conduct user validation activities, including planning, execution, documentation, and cross‑functional review, to ensure product usability, safety, and effectiveness.
• Support the analysis of customer feedback, field issues, and complaints, synthesising insights into actionable recommendations; provide input in root‑cause investigations and support teams through resolution and product improvement initiatives.
• Own the development, review, and continuous improvement of Instructions for Use (IFUs) and other product documentation, ensuring clarity, regulatory compliance, and alignment with human‑factors principles.
• Support the design and delivery of advanced Field Clinical Engineering (FCE) training materials.
• Provide support and scientific input into clinical trials and product evaluations, ensuring robust testing of proposed features, algorithms, prototypes, and new therapeutic indications.
• Act as a strategic partner to cross‑functional engineering, technical services, field clinical engineering, and clinical research teams, influencing product roadmaps and ensuring the voice of the user is integrated throughout the development lifecycle.
• Support Field Clinical Engineering teams,
Work with key customers and clinical stakeholders to deeply understand product needs, preferences, and emerging opportunities, translating insights into product enhancements and strategic direction.

Essential Requirements

• Bachelor's degree or higher in Biomedical Engineering or related discipline
• Knowledge of signal processing, control systems, and related engineering fields
• Knowledge of human physiology and anatomy
• Working knowledge of regulatory requirements
• Comfortable working independently and as part of a cross-functional team
• Flexible and positive attitude, team-oriented
• Good communication skills (verbal and written), comfortable speaking and presenting to others
• Ability to manage multiple priorities
• Must be able to work independently under limited supervision
Strong analytical skills

Desirable Requirements

• Experience with neuromodulation, implantable devices, or neurotechnology
• Experience in the clinical use of medical devices
• Experience in human factors and usability engineering principles
• Experience in medical device design and development
• Knowledge of risk management processes (ISO 14971)
• Knowledge of medical device usability standards (IEC 62366)
• Experience working with global regulatory bodies (FDA, TGA, MDR)
• Experience supporting clinical studies or clinical trials
Knowledge of design controls and product development processes

At Saluda, we challenge boundaries. We innovate and think beyond the conventional. We disrupt.

Are you Ready to Join? If you would like to be part of our team developing the world's next generation of implantable device technology, contribute to making an impact on patient care, then this is the opportunity for you! Please APPLY NOW!

Applications will only be considered from candidates with the appropriate approval to work in Australia, no visa or sponsorship is available for this role.

All eligible candidates are invited to apply. We respectfully ask for no agency approaches.