Job Description
Overview
We are seeking an experienced Program Manager to lead the development and lifecycle management of the Automated Impella Controller (AIC) program. This highly visible, heavily funded role will oversee capital equipment projects that integrate hardware, software, and digital patient interfaces for advanced medical devices. The ideal candidate will ensure compliance with FDA regulations, manage risk, and drive execution from concept through launch.
Key Responsibilities
Program Leadership
- Manage end-to-end development of AIC, including hardware, embedded software, and digital connectivity.
- Oversee cross-functional teams (10–50 members) across engineering, quality, regulatory, and operations.
- Drive project execution within timelines and budgets ($5MM–$20MM).
Design Control & Documentation
- Maintain complete Design History File (DHF) for audits and regulatory approval.
- Ensure all design changes comply with FDA guidelines and internal quality systems.
Lifecycle Management
- Support on-market products through updates, enhancements, and issue resolution.
- Implement sustainable lifecycle strategies for hardware and software components.
Risk & Compliance
- Anticipate challenges associated with Class II and III medical devices.
- Manage risk assessments and mitigation plans throughout development.
Required Qualifications
Experience
- 10+ years in product development, with at least 5 years in program/project management.
- Proven track record supporting Class II or III medical device launches (Class I experience a plus).
- Experience managing multi-million-dollar budgets and large cross-functional teams.
Technical Expertise
- Strong understanding of hardware and software integration in medical devices.
- Familiarity with embedded systems, user interfaces, and digital connectivity for patient data exchange.
Lifecycle Knowledge
- Hands-on experience with on-market support, updates, and sustainable lifecycle management.
Soft Skills
- Exceptional leadership, communication, and problem-solving abilities.
- Ability to navigate complex regulatory environments and anticipate risks.