Base: $115,000.00 to $197,800.00; bonus/equity: el...
Medical device project management
Cybersecurity initiatives
Obsolescence mitigation projects
Lead cross-functional projects focused on the ongoing support and enhancement of the Impella AIC system, including cybersecurity, obsolescence management, CAPAs, and system upgrades
Job Summary
Lead cross-functional projects focused on the ongoing support and enhancement of the Impella AIC system, including cybersecurity, obsolescence management, CAPAs, and system upgrades.
Identify components and technologies nearing end-of-life, develop mitigation strategies, and execute replacement or redesign projects to ensure continued compliance and performance.
Ensure all activities adhere to FDA, ISO, and other relevant standards, and prepare documentation and reports for audits and regulatory submissions.
Matching Summary
Lead cross-functional projects focused on the ongoing support and enhancement of the Impella AIC system, including cybersecurity, obsolescence management, CAPAs, and system upgrades.
Salary
Base: $115,000.00 to $197,800.00; Bonus/Equity: eligible for annual performance bonus; Benefits: medical, dental, vision, life insurance, disability, retirement plan, 401k, long-term incentive program
Skills & Requirements
Must-have
medical device project management
cybersecurity initiatives
obsolescence mitigation projects
CAPA management
cross-functional team leadership
regulatory compliance support
Nice-to-have
reimagining how we heal
passion for saving lives
inspirational and collaborative leader
Key Requirements
BS in Biomedical, Electrical, Mechanical Engineering, or related scientific discipline
7+ years' experience leading complex sustaining projects
Experience managing CAPAs, lifecycle projects, and regulatory compliance
Experience with cybersecurity protocols and obsolescence projects