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.
What We’re Looking For...
Working within our Manufacturing team, as our Production Technical Lead you will be responsible for:
- Drive and support the Change Management process for Production related matters. Create and manage change configurations to manufacturing processes, documentation, and tool information, as well as monitor & coordinate PLM system, change workflows activities through the different stages, by collaborating with relevant production stakeholders.
Your role will include:
- Plan & implement changes following the change control procedure, ensuring that change scope, rationale, and supportive information are clearly documented and explained to stakeholders.
- Engage change management collaborators and reviewers to address and resolve any issues and minimise delays in review and approval processes.
- Liaise with all relevant stakeholders to implement and transfer configuration and operational details between key systems Arena and QAD.
- Monitor the progress of all changes impacting production. Actively follow up on current or emerging delays.
- Track (daily) the status of change review status, and change ticket completion, and escalate any concerns about constraints, priority conflicts, or other issues that require resolution.
- Assist in the implementation and improvement of standard operating procedures (SOPs) and work instructions (WIs) used to build Saluda products. Incorporate the non-conforming report (NCR) process for physical dispositions, repairs, or rework and complete appropriate reporting and documentation.
- Support and collaborate the required production related NCRs, from containment, and investigation to disposition stages.
- Proactively lead and support continuous improvement initiatives to enhance quality, efficiency, and overall operational performance.
- Provide support to Production Trainer, Senior Production Line Supervisors, Production Support Specialist, and Production Operators.
- Provide administrative support when required (SOP, QAD, Arena, and ADP systems).
- Rotation to other job-related areas within the company for cross-training. Foster and maintain strong, collaborative relationships across internal teams and with external suppliers to support seamless operations and continuous improvement.
About you:
- Solid knowledge & experience driving and managing Change Management processes and continuous improvement.
- Strong root cause analysis skills and experience driving non-conformance reports.
- Strong time management skills, attention to detail, and accuracy in completing daily tasks.
- Strong work ethic with high levels of initiative, demonstrating the ability to plan and prioritise to meet, at times, tight deadlines under pressure.
- Strong interpersonal and communication skills.
- Ability to handle multiple priorities and develop strong relationships with customers, fellow employees, and suppliers.
- Ability to facilitate and manage change input from cross-functional stakeholders.
- Strong organisational skills and a demonstrated ability to independently manage multiple tasks and priorities under time constraints.
- Proven computer literacy with specific skills in MS Excel, MS Word and Power BI.
It’s not essential, but nice if you have:
- A Bachelor of Engineering or equivalent.
- Knowledge of regulatory requirements and experience with working in a quality-controlled environment. Lean Six Sigma certification.
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.
