Job Title: Senior Program Manager (AI)

Location: Remote

Clearance: Public Trust Preferred

Who We Are:

Rackner is a software consultancy that builds cloud-native solutions for startups, enterprises, and the public sector. We are an energetic, growing consultancy with a passion for solving big problems for both startups and enterprises. Each of us enable digital transformation for large organizations through the newest in distributed technologies as we are laser focused on end-to-end application development, DevSecOps, AI/ML and systems architecture and our methodology focuses on cloud-first and cost-effective innovation. Our customers hail from a diverse, ever-growing list of industries.

Overview:

The mission of the Center for Devices and Radiological Health (CDRH) is to protect and promote public health. CDRH assures patients and providers have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products. Rackner will be working with CDRH to help develop a comprehensive multi-faceted system to streamline FDA's capability to use state-of-the-art approaches to generate and evaluate clinical evidence for regulatory decision-making, including advanced artificial intelligence and machine learning (AI/ML).

Position Overview:

Rackner is seeking a Senior Program Manager to oversee the planning, direction and create and manage all project schedules. The Senior PM will manage all deliverables and track and report all metrics. The Senior Program manager will provide overall leadership, coordination, management, and reporting for all activities and tasks, while identifying improvements, resolutions, and solutions to ensure the program's success.

Responsibilities/Requirements:

Technical Expertise:

· Strong understanding of AI, machine learning algorithms, and their applications in medical devices or healthcare

· Knowledge of medical device software development processes, including regulatory standards and compliance requirements

· Excellent project management skills, with the ability to oversee multiple projects simultaneously, manage timelines, and allocate resources effectively

Education Background / Professional Experience:

· Bachelor's or Master's degree in Biomedical Engineering, Computer Science, or a related field. An advanced degree is preferred

· At least 7 years of experience in program management, with specific experience in AI and medical devices or healthcare technology sectors

· Proven track records in managing AI projects, particularly in the development and implementation of AI-driven medical devices or solutions

· Demonstrated ability to lead and manage cross-functional teams, including technical experts, in a highly regulated environment

Benefits/Additional Info:

Rackner embraces and promotes employee development and training and covers the cost of certifications relevant to a position and the technologies/services provided. Fitness/Gym membership eligibility, weekly pay schedule and employee swag, snacks & events are offered as well!

· 401K with 100% matching up to 6%

· Highly competitive PTO

· Great health insurance with large network of providers

· Medical/Dental/Vision

· Life Insurance, and short- & long-term disability

· Industry-Leading Weekly Pay Schedule

· Home office & equipment plan