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

The Post-Market Quality Engineer is responsible for performing analysis of Saluda medical devices, completing robust and detailed investigations, assessing risk of reported events, product performance trending, and the overall maintenance of the returned product analysis laboratory and process at the Minnesota site.

Accountabilities and Associated Responsibilities:

• Own investigation of complaints by evaluating returned products to confirm the reported event, determine the cause, and assess the risk.
• Become a product and procedural expert to provides input into understanding product performance, and design, development, and manufacturing improvement activities.
• Prepare and contribute to product trending reports and cross-functional trending reviews to ensure Saluda product continue to perform safely and effectively.
• Support the other quality initiatives, including CAPAs, by assisting in the investigation and implementation of corrective actions as needed.
• Identify process improvement opportunities and participate in projects to improve efficiency and robustness of complaint processes.
• Perform decontamination of returned products prior to evaluation.
• Partner with external suppliers to ensure the timely review and analysis of returned products that were manufactured for Saluda Medical.

Essential Requirements:

• Bachelor's degree or higher in Materials Science, Electrical Engineering, Mechanical Engineering, Biomedical Engineering or related discipline.
• 2+ years’ experience in the medical device industry or other regulated industry.
• Experience with electro-mechanical devices.
• Demonstrated strong attention to detail to ensure thoroughness of product analysis and documentation of results.
• Ability to work on-site at Saluda Minnesota site and laboratory.