Job Title: Program Manager
Reports to: COO
About CardiacBooster:
CardiacBooster is a medical device company developing a new and innovative device to support the heart. Heart support devices are used by interventional cardiologists to stabilize patients in times of cardiogenic shock and acute heart failure. We are an enthusiastic team with diverse backgrounds and expertise, located in Galway, Ireland, and Nijmegen, Netherlands. CardiacBooster is an equal opportunity employer.
Job Description:
The Program Manager will be an experienced medical device professional with intimate knowledge of medical device development for interventional cardiology. The key responsibility of this role will be to lead the execution of the Program for the company’s novel cardiac support device, and to develop the processes required to govern product development and associated quality assurance in compliance with regulatory and ISO requirements. The Program Manager will work closely with marketing, regulatory affairs and clinical affairs functions to ensure clinically and market-oriented device development. He/She will provide project leadership and share the responsibility of realising the product concept’s full potential.
The successful candidate will have entrepreneurial spirit, the required persistence to succeed in a start-up environment, and the ability to work in a self-directed manner with minimal direction and supervision. He/She will have hands-on knowledge and experience in the development of cardiovascular devices. The Director of Program Management will have excellent leadership and communication skills, complemented by an in-depth industry knowledge. Based on his/her experience, he/she will have an established network within the interventional cardiology community. The successful candidate will have a minimum of ten years of medical device development experience, and have a Master’s Degree in a relevant engineering discipline such as biomedical engineering, or equivalent experience. The Program Manager will work from the company’s office in Galway and be in a position to travel now and again.
Essential Job Responsibilities:
- Develop, implement and manage a robust program plan; responsible for understanding the status of the project ongoing and overseeing a program of work to transfer it to manufacturing and scaling in a highly regulated environment.
- Along with key stakeholder you will implement a rigorous engineering review process in device development to minimise risks in design realisation.
- Work closely with task and workstream owners to ensure on-time completion of tasks and adequate prioritization of critical path tasks
- Responsible for developing various levels of project plans and integrating them together and managing the schedule to project completion.
- Responsible for keeping all stakeholders appropriately appraised of progress.
- Be able to respond to change and uncertainty by proposing alternative risk assessed solutions for progression and implementation.
- Anticipate risks and challenges; proactively ensure availability of adequate mitigation plans
- Develop and manage program budgets
- Drive a first-class team. Identify resource needs and work with functional leads to advise on recruitment as necessary
- Support implementation of a robust quality system; ensure compliance with quality system
- Ensure adequate IP generation to protect novel developments and findings
Required Qualifications & Characteristics:
- Master’s Degree in a relevant engineering discipline, or equivalent experience
- Advanced expertise in Program Management project execution and associated tools.
- Being extremely comfortable in managing change with agility & adaptability.
- Detail orientated, very well organized and able to deliver multiple projects to completion simultaneously.
- Self-directed leader with entrepreneurial drive
- Experience in development of cardiovascular devices within structural heart would be an advantage
- Demonstrated ability to lead teams to outstanding achievements
- Intimate understanding of the medical device industry and interventional cardiology device requirements
- Excellent communication skills in English
The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel as classified.