Saluda Medical Pty Ltd.
Program Manager Sustaining (Remote)
Program Manager Sustaining | Saluda Medical Pty Ltd. | UnitedStates
Saluda is a global healthcare company that is redefining Spinal CordStimulation (SCS) therapy at the intersection of advanced AI, real-timediagnostics, and ground-breaking clinical evidence. Every day at Saluda, weare focused on the dignity of responsibility to elevate human health andoptimize clinician operations by unlocking the power of data and science to...
Program Manager Sustaining | Saluda Medical Pty Ltd. | United States
Saluda is a global healthcare company that is redefining Spinal Cord Stimulation (SCS) therapy at the intersection of advanced AI, real-time diagnostics, and ground-breaking clinical evidence. Every day at Saluda, we are focused on the dignity of responsibility to elevate human health and optimize clinician operations by unlocking the power of data and science to reach patients in need.
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, this position is responsible for managing multiple Sustaining Engineering projects and ensuring that business needs are met while effectively partnering with subject matter experts, process owners and functional leaders across the organization.
Accountabilities and Associated Responsibilities:
- Partner with Supplier Management team to develop and maintain active summary of projects to include scope, schedule, resources, risks
- Collaborate with functional management to assess, plan and execute sustaining projects ensuring compliance, supply continuity and COGS goals
- Manage competing priorities and project constraints by aligning with stakeholders and communicating to senior management
- Foster strong working relationships with both internal and external teams to optimize productivity
Follow and engage in ongoing improvement to Saluda’s Quality Management System.
Essential Requirements:
- Minimum 5 years experience as project leader in medical device
- Excellent organizational skills to manage and track deliverables of multiple projects
- Demonstrated knowledge of planning and project management methodologies and tools
- Understanding of medical device product development lifecycle under a compliant QMS
- 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
Desirable Skills and Experience:
- Experience in medical device product development as technical and project leader
- Ability to diligently advance projects under regulatory oversight by FDA, TGA, Notified Bodies, and other government officials
- Familiarity with neuromodulation, lead manufacturing, IPG manufacturing, DOE, IQ/OQ/PQ, and sterile barrier packaging with UDI labels
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