Engineering · Full-time · MN, United States
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, NPI and Process Excellence, the primary role of this position is to support introduction of new products by providing technical expertise to contract manufacturing programs executing product launches and transfers. This role works with a broader team of Supply Chain, Quality, and Regulatory to introduce, maintain, or scale products through ongoing improvements and focused initiatives to improve patient experiences.
Accountabilities and Associated Responsibilities:
Support new product introductions and liaise with contract manufacturers of Saluda’s products to assist with successful transfer to production
Foster strong working relationships with Saluda’s manufacturing partners as well as internal team members to optimize productivity
To perform, document and/or review engineering activities such as design verification, process validation, engineering changes
Execute and/or drive execution of deliverables to support Product Development Lifecycle
Follow and engage in ongoing improvement to Saluda’s Quality Management System
Up to 25% Travel
Essential Requirements:
Desirable Skills and Experience:
Experience with Class III medical device
Background that includes new product introduction and ramp
Knowledge of design and development process for new products and/or product changes (e.g. design inputs, design verification and validation)
Experience in risk management (hazards analysis, dFMEA, pFMEA, risk/benefit analysis)
Ability to diligently advance projects under regulatory oversight by FDA, TGA, Notified Bodies, and other government officials
Experience with Solidworks CAD software and statistical analysis software (e.g. Minitab, JMP)
Working knowledge of regulatory requirements