Sr Director / VP Research & Development - Cardiovascular Device (Start-up)Location: Must reside or be commutable to Galway, IrelandAbout the Company:Our client is a medical device company developing a new and innovative device to support the heart.Job Description:The Sr Director / VP R&D will be an experienced medical device professional with intimate knowledge of medical device development for interventional cardiology. The key responsibility will be to lead the execution of the product development of 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 successful candidate will work closely with marketing, regulatory affairs, and clinical affairs functions to ensure clinically and market-oriented device development. He/She will provide team and project leadership and share the responsibility of realizing the product concept’s full potential. The candidate must possess an entrepreneurial spirit, persistence to succeed in a startup environment, and the ability to work in a self-directed manner with minimal direction and supervision.Hands-on knowledge and experience in the development of cardiovascular devices is essential. The candidate will have excellent leadership and communication skills, complemented by in-depth industry knowledge and an established network within the interventional cardiology community. A minimum of six years of medical device development experience and a Master’s Degree in a relevant engineering discipline such as biomedical engineering, or equivalent experience, is required.The Sr Director / VP R&D will work from the company’s office in Galway and be able to travel up to 20% of the time.Key Responsibilities:Develop, implement and manage a robust product development plan; ensure achievement of pre-defined milestones within timelines and budget.Anticipate risks and challenges; proactively ensure availability of adequate mitigation plans.Implement a rigorous engineering review process in device development to minimize risks in design realization.Develop and manage research and development budgets.Lead a first-class team; identify resource needs and recruit as necessary.Support implementation of a robust quality system; ensure compliance with quality system.Work with the CTO to establish a network of physician advisors and expert consultants.Ensure adequate IP generation to protect novel developments and findings.Manage relationships with third-party research, development, and manufacturing vendors.Required Qualifications & Characteristics:Master’s Degree in a relevant engineering discipline, or equivalent experience.Self-directed leader with entrepreneurial drive.Established network in the field of device development.Experience in the development of cardiovascular devices, with structural heart expertise as an advantage.Experience in the development of electromechanical control consoles.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.Seniority Level:DirectorEmployment Type:Full-timeJob Function:Research, Engineering, and Project ManagementIndustries:Medical Equipment Manufacturing
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