Electrical Engineer - Hardware Product, Sustaining

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. Saluda is a global company with headquarters in Australia and offices in the United States and Europe.

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.

Reporting to the Director of New Product Introduction & Process Excellence, the primary role of this position is to

support commercial products by providing technical expertise and ownership of product design and manufacturing changes at contract manufacturers to ensure supply continuity and quality system requirements. This role works with a broader team of Supply Chain, Quality, and Regulatory to maintain products through ongoing improvements and focused initiatives to improve patient experiences.

Responsibilities:

• To liaise with manufacturers of Saluda’s products to assist with successful completion and timely delivery of: sustaining project goals, production process implementation activities and production output targets
• Foster strong working relationships with Saluda’s manufacturing partners as well as internal team members and work to optimise productivity
• Be accountable for product engineering from design transfer through end of life for one or more parts of Saluda’s Evoke system
• To perform, document and/or review engineering activities such as design verification, process validation, engineering changes
• To coordinate the reporting of production-related issues, assist with investigations and problem resolution, and support or manage the implementation of related product or process changes initiated by Saluda or its manufacturing partners
• To identify product obsolescence risks or improvement opportunities, and assist with the implementation of these changes
• Follow and improve Saluda’s Quality Management System.
• Up to 25% travel
• Other duties as required
  
  

Essential Requirements:

• 7 years engineering experience with a minimum of 5 years’ experience with medical devices, product / process development, or sustaining engineering
• Electrical hardware development/manufacturing background
• Proven collaboration skills with external supply chain partners
• Written and verbal communication skills to clearly explain change and risk
• Mindset to get things done in an emerging company
• Bachelor's degree in Engineering (or equivalently relevant field)
• Demonstrated ability to liaise with external parties and represent the company’s interests
  
  

Desirable Skills and Experience:

• Experience with Class III medical device
• Ability to diligently advance projects under regulatory oversight by FDA, TGA, Notified Bodies, and other government officials.
• Experience with Altium PCB Design, Solidworks CAD, and statistical analysis software (e.g. Minitab, JMP).
• Familiarity with neuromodulation, lead manufacturing, IPG manufacturing, DOE, IQ/OQ/PQ, measurement system analysis, and sterile barrier packaging with UDI labels.
• Working knowledge of regulatory requirements