Manufacturing Engineer

Saluda Medical is the pioneer in closed-loop Spinal Cord Stimulation (SCS), a ground-breaking SCS therapy that can measure the spinal cord's response to stimulation and make real-time adjustments to therapy. At Saluda, we challenge boundaries. We innovate and think beyond the conventional. We disrupt. With the passion and energy of an accomplished team of seasoned experts, our focus is to revolutionize the standard of care in the neuromodulation space by transforming the lives of patients suffering from debilitating pain.

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:

1. Participate in the specification, design, development, and production of Saluda Medical products,


2. Support the implement and validation of processes into a production environment, and


3. Support efforts to continuously improve the efficiency, effectiveness, quality, and processes related to the manufacturing and production of Saluda products.

Accountabilities and Associated Responsibilities:

Production 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.