Product Support Engineer

2 weeks ago

Minneapolis, Minnesota, United States Saluda Medical Full time
Position Overview

Saluda Medical is at the forefront of innovation in closed-loop Spinal Cord Stimulation (SCS) technology, which is designed to assess the spinal cord's response to stimulation and make real-time adjustments to enhance therapeutic outcomes. With a global presence, Saluda operates from its headquarters in Australia and has additional offices in the United States and Europe.

At Saluda, we are committed to pushing the limits of what is possible. Our team of experienced professionals is dedicated to transforming the standard of care in the neuromodulation field, ultimately improving the lives of patients dealing with chronic pain.

Key Responsibilities:

  • Collaborate with product manufacturers to ensure the successful execution and timely achievement of sustaining project objectives, production process implementation, and output targets.
  • Develop and maintain strong relationships with manufacturing partners and internal teams to enhance productivity.
  • Oversee product engineering from design transfer to end-of-life for various components of Saluda's Evoke system.
  • Conduct, document, and review engineering tasks such as design verification, process validation, and engineering modifications.
  • Coordinate the reporting of production-related challenges, assist in investigations and problem-solving, and support or manage the implementation of product or process modifications initiated by Saluda or its manufacturing partners.
  • Identify risks related to product obsolescence or opportunities for improvement, and facilitate the implementation of necessary changes.
  • Adhere to and enhance Saluda's Quality Management System.
  • Willingness to travel up to 25% as required.
  • Perform additional duties as assigned.

Essential Qualifications:

  • A minimum of 7 years of engineering experience, including at least 5 years in medical devices, product/process development, or sustaining engineering.
  • Background in electrical hardware development and manufacturing.
  • Demonstrated ability to collaborate effectively with external supply chain partners.
  • Strong written and verbal communication skills to articulate changes and associated risks clearly.
  • A proactive mindset suited for a dynamic company environment.
  • Bachelor's degree in Engineering or a related field.
  • Proven capability to engage with external stakeholders and advocate for the company's interests.

Preferred Skills and Experience:

  • Experience with Class III medical devices.
  • Ability to effectively manage projects under regulatory oversight from agencies such as the FDA, TGA, and Notified Bodies.
  • Familiarity with Altium PCB Design, Solidworks CAD, and statistical analysis tools (e.g., Minitab, JMP).
  • Knowledge of neuromodulation, lead manufacturing, IPG manufacturing, design of experiments (DOE), installation qualification/operational qualification/performance qualification (IQ/OQ/PQ), measurement system analysis, and sterile barrier packaging with UDI labels.
  • Understanding of regulatory requirements in the medical device industry.

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