Labelling Engineer/Specialist Fixed Term (4 months)

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...

This role will play a critical part in supporting Saluda’s labelling initiatives, with a particular focus on EU labelling remediation for Italy. Reporting to the Senior Manager, Mechanical Engineering, you will work closely with the Product Development and Regulatory teams to generate label designs and coordinate design verification activities related to product labelling requirements.

This role is a 4-month Fixed Term Contract.

Your role will include: 

• Execute labelling design and verification activities and assist in the control of release into the production environment.


• Responsible for driving labelling activities to deliver labelling content for projects with changing regulatory jurisdictions. This will include product, sales, and sterile packaging labels, labelling specifications, instructions for use (IFU), patient ID cards and other forms of regulated labelling materials, in compliance with global and regional standards and regulations.


• Involvement in standardising the label design approach and remediating existing labelling.


• Communicate to teams and management on the progress of labelling related projects.


• Work with cross functional departments to generate label design inputs, implement label changes, and problem solve labelling related issues as required.


• Support relevant non-confirming events (NCRs) and CAPAs, monitoring progress where applicable and drive through to completion for all action items pertaining to label issues, including problem solving to resolution, root cause analysis and implementation of corrective item.


• Contribute to improving quality, process efficiency, and continuous improvements.


• Maintain a tidy and safe workplace and storage areas.


• Maintain good team relationships within the company and with our suppliers.

About you: 

• A 2 or 4 year degree program in Industrial, Manufacturing Engineering, Mechanical Engineering, Biomedical Engineering, or related discipline.


• A minimum of 2 years’ experience in labelling role within a Medical Device industry and/or other regulated industry.


• Experience with CAD/CAM design software, such as SolidWorks.


• Strong command of MS Office: Word, Excel, PowerPoint.


• Excellent written and verbal communication skills


• High attention to detail.


• Self-starter with demonstrated efficient work methods, analytical and problem-solving skills and ability to handle multiple tasks.

• Strong time‑management skills with the ability to work to tight deadlines.

It’s not essential, but nice if you have:

• Have worked in a formal quality assured environment such as ISO 9001 or ISO 13485.


• Experience in medical device design and development.


• Knowledge in design software, Adobe Illustrator, is an advantage.


• Knowledge in label printing applications and ERP systems, such as BarTender and QAD, is an advantage.


• Knowledge of barcoding, UDI requirements and GS1 identification is an advantage.


• Familiarisation with Medical Device labelling standards and requirements, such as 21 CFR 801 and EU MDR, is an advantage.


• Production scale-up and process development/improvement experience.

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.