Medical Device Program Manager
At PathAI, we're applying Computer Vision, Machine Learning and AI in amazing ways to pathology, healthcare, and detecting cancer and other diseases. We're applying our work to drug development, the clinical space, and as a global health initiative. Since it's early days for us, there is a lot of work to do and a lot of great products to build, and a product-driven approach is critical to the success of everything we aspire to do.
Reporting to the Chief Scientific Officer, the Medical Device Program Manager will be accountable for delivering the end to end execution strategy (concept to global launch and end of life) of all medical device development programs at PathAI. This is a highly matrixed and cross functional role responsible for leading and motivating a complex cross functional team from several functions including product, engineering, scientific programs, regulatory, clinical affairs, quality and commercial.
The Medical Device Program Manager will define the medical device program plan and drive successful project / program execution including identifying and communicating risk and mitigation options at the programmatic level to senior management. The successful candidate will be a skilled communicator and have a track record of fostering an environment of collaboration, innovation, flexibility and performance as it relates to delivering complex software based medical devices on time and on budget.
- In collaboration with core team members, be responsible for the creation of the program and project work breakdown structures that integrates key deliverables at various stages of medical device development.
- Be the single accountable owner of the overarching medical device development process from concept to end of life
- Set budget, staffing, tools (resources) and timeline projections for the entire scope of the medical device program and ensure the functional teams fulfill their responsibilities in accordance with the project plan and in compliance with PathAI’s standards, QMS and required regulations
- Understand product complexity as it relates to all cross functional requirements and work to resolve conflicting requirements across teams. Strive for team alignment and buy-in for complex trade-off decisions.
- Develop an operating model that allows for communication of program progress and programmatic risks to senior management and work with team members to evaluate and present alternative solutions to effectively resolve problems and/or mitigate barriers to the timely delivery of the program.
- Serve as medical device development subject matter expert and bring best practices to the team while maintaining a strong degree of flexibility and approaches that are right sized for a fast growing technology start-up.
- Have a deep appreciation for patient safety and quality/compliance risks and be able to propose an acceptable level of risk consistent with comprehensive business needs.
- Build and foster a cohesive team environment through transparent and candid communication
- BS degree in Mechanical Engineering, Materials Science & Engineering, Biomedical Engineering or equivalent is required. An advanced degree in an engineering discipline or MBA is preferred.
- At least 10 years relevant experience in product development and design with at least 5 years product development and design experience in complex medical devices/products.
- Outstanding interpersonal, communication, presentation and influencing skills
- Experience in new product development planning multiple work-streams, identifying risk and implementing action plans to optimize time lines and reduce execution risk
- Have full knowledge of related disciplines needed to execute the program, including software development, quality engineering, regulatory guidances and product development best practices
- PMP certification or equivalent is preferred
- Experience in agile software development in context of medical device development
- Experience in human factors testing per FDA regulations
- Has successfully launched multiple new medical device products from concept through launch.
- Understanding of the in vitro diagnostic device development
- Understanding of complex medical devices including imaging technologies
PathAI is an equal opportunity employer, dedicated to creating a workplace that is free of harassment and discrimination. We base our employment decisions on business needs, job requirements, and qualifications — that's all. We do not discriminate based on race, gender, religion, health, personal beliefs, age, family or parental status, or any other status. We don't tolerate any kind of discrimination or bias, and we are looking for teammates who feel the same way.
PathAI does not accept unsolicited submissions from third-parties