The primary role of this position is to support the design and development of advanced neuromodulation systems for the next generation of implantable stimulation devices. In particular to:
* Participate in the specification, design, development, and production of Saluda Medical products,
* Support the implement and validation of processes into a production environment, and
* Support efforts to continuously improve the efficiency, effectiveness, quality, and processes related to the manufacturing and production of Saluda products.
Accountabilities and Associated ResponsibilitiesProduction Support
* Support production as the Manufacturing Engineer on production issues in both cleanroom and externals manufacturing areas.
* Manage a variable workload to meet/exceed Key Performance Indicators (KPIs), such as yield, routing times and uptime.
* Identify and implement permanent and effective technical / system solutions utilising problem solving methodologies to improve yield.
* Prepares charts, graphs, and diagrams to illustrate workflow, routing, floor layouts, material handling, and machine utilization.
* Recommend methods for improving worker efficiency and reducing waste.
* Implement and support QA functions (quality records, product inspections, etc.) related to materials, supplies, and products throughout company.
* Support the supply chain and manufacturing operation to ensure continuous and uninterrupted flow of product and maintain production output per established schedules.
* Improve 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.
* Work as part of production support team to drive product and process improvements/ developments.
Process Design & Improvement
* Develop tools/jigs/assembly aids.
* Identify process risks and controls (pFMEA).
* Track and optimize yield and process capability.
* Ensure proper management of changes to processes.
Process Validation
* Plan and implement process validation activities (including tool qualification).
* Ensure processes can produce the required outputs with the required quality level.
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.
Essential Requirements
* Degree qualified in Industrial, Manufacturing Engineering, Mechanical Engineering, Biomedical Engineering, or related discipline.
* 5 years' experience in engineering in a manufacturing or production environment, preferably in implantable devices.
* Understanding of regulatory requirements and experience working in a quality-controlled environment.
* Experience in test method validation
* Experience in process optimisation including debugging
* 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.
* Software experience including Solidworks.
* Excellent written and verbal communication skills.
* Knowledge of problem-solving and strong team working skills.
Desirable Requirements
* Have worked in a formal quality assured environment such as ISO 9001 or ISO 13485.
* Experience in medical device.
* Knowledge of labelling software and physical attributes is advantageous but not critical.
#J-18808-Ljbffr