AddressAbout 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 with a team of engineers as our Manufacturing Engineer you will be responsible for participating in the specification, design, development and production of Saluda Medical products, implementing and validating processes into a production environment, and leading efforts to continuously improve the efficiency, effectiveness, quality, and processes related to the manufacturing and production of Saluda products.
Your role will include:
Production Support
- Prepares charts, graphs, and diagrams to illustrate workflow, routing, floor layouts, material handling, and machine utilization.
- Search out, recommend and implement process improvements.
- Recommends methods for improving worker efficiency and reducing waste of materials and utilities such as restructuring job duties, reorganizing work flow, relocating work stations and equipment, and purchase of equipment.
- Implement and support QA functions (quality records, product inspections, etc.) related to materials, supplies, and products throughout company.
- Plan activities such as product builds, assembly, inspection, testing, and rework to support the production schedule and project timelines.
- Support the supply chain and manufacturing operation to ensure continuous and uninterrupted flow of product and maintain production output per established schedules.
- Establish and improve standard operating procedures (SOP’s) and work instructions (WI’s) used to build Saluda products. Incorporate the non-conforming report (NCR) process for physical dispositions, repairs, or rework and completes appropriate reporting and documentation.
- Build, support and maintain the labelling capabilities in production.
Process Design & Improvement
- Develop tools/jigs/assembly aids.
- Identify Critical Process Parameters and design effective control systems.
- Identify process risks and controls (pFMEA).
- Track and optimize yield and process capability.
- Ensure proper management of changes to processes.
Process Implementation
- Maintain high quality work instructions.
- Manage equipment and test specifications for production.
- Create and manage tool records.
- Develops and conducts training programs on the safe operations of the equipment. Demonstrates skills to trainees and experienced assemblers and technicians.
Process Validation
- Plan and implement process validation activities (including tool validation).
- Ensure processes can produce the required outputs with the required quality level.
Equipment Management
- Assist in the calibration and maintenance of production equipment.
- Develops and writes equipment specifications, performance requirements, cost analysis, and proposal for integrating machinery and equipment into manufacturing process.
Product Development and Quality support
- Interact with other departments in the implementation of new products, processes, or programs.
- Confers with management and engineering staff to implement plans and recommendations.
- Responsible for ensuring the timely and successful transfer and ramp up of products from product development into full production through establishing efficient, stable and repeatable manufacturing processes in collaboration with the product development teams and suppliers.
- Assist in the analysis and documentation of production requirements for Saluda Medical products.
- Manage and review changes in BOMs, system build standards, and ensure correct part numbering and structure accuracy.
- Assist in the management of time and cost aspects of development projects.
- Support efforts related to audits, compliance, and regulatory submissions.
- Supports development engineers in the implementation and deployment of new products, process improvements, and design transfer activities, including documentation related to production activities.
- Assist and participate in the review meetings for requirements, hazards/risks, V&V and design, and product traceability.
General
- Comply with all Saluda Medical policies, rules, and guidelines as well as relevant quality processes and procedures.
- Participate in department and project/team meetings.
- 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.
- Other duties required from time to time directed by your manager.
About you:
- A 2- or 4-year degree program in Industrial, Manufacturing Engineering, Mechanical Engineering, Biomedical Engineering, or related discipline.
- A minimum of 3 years’ experience in engineering in a manufacturing or production environment.
- Working knowledge of regulatory requirements and experience working in a quality-controlled environment.
- Ability to work in shop floor, laboratory, clean room, and office environments (standing and sitting).
- Manual dexterity in order to work with small tools, equipment, and be able to properly use optical microscopes.
- Able to work with chemicals and adhesives.
- Experience with computers: CAD/CAM design software, labelling software, word processing, and spread sheets.
- Excellent written and verbal communication skills.
- Strong problem-solving and team working skills.
It’s not essential, but nice if you have:
- Have worked in a formal quality assured environment such as ISO 9001 or ISO 13485.
- Production scale-up and process development/improvement experience.
- Experience in medical device design and development.
- Knowledge of labelling software and physical attributes is advantageous but not critical.
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.
