Head of R&D

Responsibilities:

Comprehensive Management: Oversee the management and execution of research, development, and design activities for both new and existing company products; Cultivate a high-performing R&D team that promotes a culture of innovation.
Project Oversight and Technical Leadership: Define and oversee the management of R&D Projects to ensure all deliverables and objectives are met in alignment with company strategies and Design Control Procedures. Provide technical leadership to ensure that design, verification, and validation processes for products and components adhere to relevant quality standards and regulations.
Strategic Support for Operations: Lead and oversee R&D strategic and technical involvement and support to the Operations/Engineering department in DFM (Design For Manufacturing), NPI (New Production Introduction), and manufacturing scalability processes as part of ensuring company products are meeting company’s commercial plans and market demand.
Intellectual Property Development: Identify and pursue new Intellectual Property (IP) initiatives, translating these into patent applications, products, and methodologies to further enhance V-Wave’s IP portfolio.
Cross-Functional Collaboration: Work collaboratively with all necessary functional areas to advance products from proof-of-concept through validation, product launch, and throughout the full product lifecycle. This includes coordination with Quality & Compliance, Regulatory, Operations, Clinical, Medical Affairs, Marketing, and Finance.
Competitive Analysis: Monitor the development of competing products and technologies, providing technical and strategic insights to senior management.
Clinical / Commercial Support: Assist in the design, operations, and execution of clinical studies or commercial activities as required.
Compliance Participation: Engage in Material Review Board (MRB), Corrective and Preventive Action (CAPA), Risk Management, change control, and management review activities as necessary.

 
Qualifications:
Experience:

Minimum of 10 years of direct managerial experience in medical device product development.
Experience in transferring products to the production and commercialization phase.
Experience in the field of Implants, Nitinol, and delivery systems is strongly preferred.
Clinical and research expertise in cardiovascular or structural heart disciplines is strongly preferred.
Experience in both startup and corporate environments is strongly preferred.

Education:

Bachelor’s degree in Mechanical Engineering is required.
Master’s Degree or MBA is preferred.

Leadership Skills: Proven ability to effectively lead, partner, and influence across a global, cross-functional team supporting a globally commercialized product.
Strategic Mindset: Strong strategic thinking capabilities, focusing on aligning R&D activities with broader business objectives.
Organizational and Communication Skills: Exceptional organizational abilities complement excellent written and verbal communication skills.
Analytical Skills: Strong analytical capabilities that enable informed decision-making and effective problem resolution.
Language Proficiency: Highly proficient in both written and spoken English.