Position Overview We are seeking an innovative and experienced R&D Manager to lead the development and delivery of cutting-edge medical device solutions.
The successful candidate will bring deep technical expertise, strategic leadership, and a proven track record in project and team management within the medical device industry.
This role involves driving projects from concept to mass production, ensuring compliance with regulatory standards, and fostering a culture of technical excellence.
Key Responsibilities Lead the design, development, and delivery of innovative vascular medical device solutions.
Oversee program management activities, including design verification, FDA submissions, and clinical trial approvals for EU and other markets.
Manage cross-functional R&D teams, including technology SMEs specializing in materials, electronics, fluid dynamics, and more.
Develop team members by fostering a culture of innovation, first-principle engineering, and technical expertise.
Budget & Stakeholder Management, ensuring resource allocation aligns with strategic objectives.
Communicate progress and technical risks to senior leadership and the board of directors.
Translate customer needs and strategic marketing inputs into technical specifications and performance goals.
Conduct technical design reviews and manage risks to ensure the reliability and performance of devices.
Collaborate in preclinical and clinical trial preparation, ensuring compliance with ethics and regulatory authorities.
Manage vendors for critical components, ensuring quality and alignment with technical requirements.
Collaborate with marketing, clinical, and regulatory teams to drive successful outcomes.
Qualifications Bachelor's degree in Mechanical Engineering, Manufacturing Engineering, or a related field.
A Master's Degree or PhD in a similar field will be a plus.
Extensive experience in the medical device industry, with progressive responsibilities in R&D and technical leadership.
Expertise in catheter-based systems, medical devices for vascular therapies, or similar technologies.
Proven experience managing cross-functional teams and large-scale project budgets.
Deep knowledge of regulatory pathways for different markets, specially the EU.
Strong technical skills in materials (e.g., Nitinol), testing methods, and preclinical development.
Expertise in the industrialization of prototypes.
Key Skills Leadership: Proven ability to lead and develop high-performing technical teams.
Technical Expertise: In-depth understanding of material sciences, product development, and device testing.
Communication: Strong verbal and written communication skills for cross-functional and executive-level reporting.
Problem-Solving: Skilled in risk assessment and mitigation in highly complex, regulated environments.
Innovation: Commitment to fostering a culture of innovation and knowledge leadership.
What We Offer Opportunity to lead groundbreaking projects in the medical device industry.
Collaborative and innovation-driven work environment.
Comprehensive benefits and opportunities for professional development.
This role is pivotal in driving the next generation of medical device innovations.
If you are passionate about transforming healthcare and have the expertise to lead from the front, we would love to hear from you