Senior Mechanical Engineer, Verification

About Saluda Medical
Founded in 2013, Saluda Medical is dedicated to transforming patients' lives with disruptive neuromodulation solutions. As leaders in the field, we have achieved exceptional pain management results through more than a decade of advanced research, development, and clinical experience. We are a global healthcare company redefining Spinal Cord Stimulation (SCS) therapy at the intersection of automated algorithms, real-time diagnostics, and groundbreaking clinical evidence. Our advanced neuromodulation systems for the next generation of implantable stimulation devices are distinguished by Dose-Control Technology via measurement of physiological response.

What We're Looking For...

As a Senior Mechanical Engineer, Verification, you will play a critical role in ensuring the safety, reliability, and performance of our medical devices through rigorous design verification testing. Reporting to the Engineering Manager, Verification you will collaborate across multidisciplinary teams to design, plan, execute and report test protocols, design test tools and drive continuous improvement initiatives.

This is a 12-month Fixed Term contract position.

Accountabilities and Associated Responsibilities:

You will be responsible for the design of, planning, execution, and documentation of design verification activities, including:

• Developing protocols to test mechanical and system requirements of products that include moulded, machined parts, implantable products, packaging and electronics.
• Producing complex 3D CAD models and drawings.
• Taking a 'hands on' approach to the fabrication of concepts and prototypes.
• Developing and commissioning test equipment, jigs & fixtures.
• Developing product and test tool/systems requirements.
• Developing and executing test method validation.
• Managing and maintaining the DVT lab environment, equipment, and documentation systems.
• Developing work in compliance with regulatory standards (e.g., ISO 13485, FDA QSR).
• Supporting root cause analysis and corrective actions for test failures.
• Ensuring adherence to Good Documentation Practices (GDP) and WH&S requirements
• Collaborating with Product Development, Quality, and Regulatory teams to ensure test coverage and compliance
• Identifying and implementing process improvements in test methods and lab operations
• Following established documentation structure to ensure consistency of format, style, quality, clarity, and accuracy.
• Performing all work duties in a manner that ensures the health and safety of all employees.
• Contribution to cross-functional project teams and product development milestones.
• Liaise and manage external test houses to perform mechanical testing including, but not limited to, packaging sterile barrier testing, hermetic enclosure testing and ISO14708 mechanical exposure testing.

Essential Requirements:

• At least 5 years' experience in similar engineering role within a highly regulated industry.
• Bachelor's degree or higher in Mechanical or Mechatronics Engineering.
• Experience in either process development or mechanical design.
• Experience in risk management methodology
• Experience in validation and verification
• Strong proficiency in SolidWorks and SolidWorks PDM, or similar.
• Working knowledge of regulatory requirements.
• Excellent written and verbal communication skills.
• Ability to communicate and collaborate with subject matter experts in various disciplines.
• Strong problem-solving and leadership skills.
• Familiarity with Microsoft Office (Word, Excel).

Desirable Requirements:

• Experience managing equipment used in an engineering lab.
• Experience in medical environment, specifically implantables or Neuromodulation.
• Familiarity with Python based scripting.
• Experience in rapid prototyping, e.g. 3D printing.

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.