Our client has an immediate need for a Transcatheter Heart Valve R&D Manager to lead its Mitral Valve Prosthesis product development activities.

Role and Responsibilities:

• Direct the design, development and testing of the transcatheter heart prosthesis.
• Lead the cross functional team in the design and development of the heart valve prosthesis, test method development, creation and execution of design verification protocols and reports to bring the product from concept to launch. 
• Needs to be self-sufficient and demonstrate collaborative leadership, being able to lead large coordination & strong communication across multiple functions, beyond R&D: quality assurance, product management/operations, regulatory affairs.
• Ensures quality in the product’s design for durability, usability, reliability, functionality, marketability, and manufacturability
• Works with external vendors as necessary to develop new technology for product development process
• Plans and coordinates all preclinical V&V program, as per international standards
• Reports directly to the CEO 

Requirements:

• B.S. or Masters degree in Mechanical Engineering, Biomedical Engineering, or related disciplines
• Minimum of seven (7) years of related experience in medical device mechanical design/product development
• Demonstrated experience as a project manager with good supervisory and teamwork skills in a fast paced and challenging environment
• Successful track record of medical device product development from concept through launch
• Strong problem-solving mindset
• Working knowledge of design control requirements for medical devices
• Excellent organizational and time management skills
• Effectiveness to achieve assigned objectives in low-structured environments
• Fluency in English is mandatory

• Prior experience in cardiovascular/nitinol medical products highly preferred
• Experience in Class III medical product development involving clinical studies highly preferred
• Some knowledge of Italian is a plus

The position is based in Northern Italy (relocation assistance is negotiable).

Availability to travel, even for long periods, is mandatory

About the Company:

• The background: a series-B funded structural heart start-up with operative sides in Italy and in US
• The mission: to provide a therapeutic platform intended to address one of the most significant unmet clinical need: mitral valve dysfunction. A cardiac disease, often fatal - always disabling, that affects, in its most severe occurrence, approximately 0.7% of the total population in Western Countries, increasing to an estimated 3.5% for the population age 75 years and older
• The business opportunity: this potential market is expected to grow to more than US$ 2.5-3B in the first decade of commercialization
• The Team: a balanced mix of experienced seniority with domain core competencies and extensive leadership in successful medtech project execution, together with youthful enthusiasm combined with a strong attitude to think out-of-the-box. A team dedicated and convinced of the ultimate success of the device

About its Product:

• The Project: to offer a cost effective therapy with the clinical benefits of surgery and all the advantages of the minimal invasive approach, through the development of a novel transcatheter permanent implantable prosthesis
• The challenge: to date, there is no similar therapeutic device approved for clinical use, despite huge worldwide investments
• The proposition: a unique approach, a breakthrough proprietary technology extremely intriguing and inspiring from an engineering standpoint, well-grounded from a clinical standpoint. Solidly validated in chronic animal models
• The milestone: to enter in clinical validation in the next months

About the Career Opportunity:

Our startup client is looking to hire a Transcatheter Heart Valve R&D Manager who will be responsible for leading cross-functional project teams through the product development cycle from concept to design, validation and regulatory approval through to delivery of a fully developed product, ready for market.  The position title is flexible based on the seniority of the candidate. This position offers a tremendous growth opportunity, as the executive structure is still in the formative stage.