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NPI Engineer
1 month ago
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: 7 years engineering experience with a minimum of 5 years’ experience supporting development of medical device design and manufacturing 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 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 #J-18808-Ljbffr
