Manufacturing Engineer

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 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.
• Recommends methods for improving worker efficiency and reducing waste of materials and utilities.
• 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). Incorporate the non-conforming report (NCR) process for physical dispositions, repairs, or rework and completes appropriate training, reporting and documentation.
• Investigation of Complaints and CAPAs assigned to manufacturing.

Process Design & Improvement

• Develop and Improve tools/jigs/assembly aids.
• Identify Critical Process Parameters and design effective control systems.
• Identify process risks and controls (pFMEA) and implements corrections.
• Track and optimize yield and process capability.
• Ensure proper management of changes to processes through ECR/ECO/DMRC/DCO.

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 and transfers knowledge to trainees, 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 Manufacturing and Quality Support

• Confers with management and engineering staff to implement plans and recommendations.
• Responsible for ensuring the timely and successful ramp up of products
• 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 manufacturing projects.
• 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.

About you:

• Bachelor’s degree or higher in Biomedical Engineering, Electrical Engineering, Electronics Engineering, Mechatronics Engineering (or similar).
• A minimum of 4 years’ post graduate experience in engineering in a manufacturing or production environment.
• Have ability to work in a team and with minimum supervision and find innovative solutions to complex problems.
• Working knowledge of regulatory requirements and experience working in a quality-controlled environment.
• Prior experience leading a project with multiple work packages and various stakeholders is a must.
• Strong process validation experience required.
• Able to work with chemicals and understand the safety aspects in relation.
• Ability to work in shop floor, laboratory, clean room, and office environments (standing and sitting).
• Experience with computers: Microsoft Office suite as well as CAD/CAM design software (is a bonus).
• Excellent written and verbal communication skills.
• Strong problem-solving and team working skills.

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

• Prior experience working within a servicing and repair manufacturing process.

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

• Production scale-up and process improvement experience.

• Experience in medical device manufacturing and have strong understanding of design for manufacture.

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!

All eligible candidates are invited to apply. We respectfully ask for no agency approaches.