Development and Industrialization Manager — Medical Device Class III Structural Heart (Startup, Northern Italy)

Company Description

StarTric is a fast-paced cardiovascular startup developing  TriClover™ , an innovative Class III transcatheter repair device to treat Tricuspid Regurgitation (TR). We’re seeking a  hands-on Development and Industrialization Manager to join our growing Team. This hybrid role spans project management, R&D, verification & validation, industrialization, and regulatory/quality interface, with a direct reporting line to the CEO and close collaboration with the CTO and COO.

The ideal candidate will take a central role in the end-to-end development of a complex implantable device, transfer of the technology from R&D to industrialization, progressively taking ownership of the full product lifecycle and contributing to establishing StarTric as an integrated, full-cycle medical device manufacturer.

Key Responsibilities

• Lead and coordinate day-to-day development activities of a Class III implantable device.
• Manage project timelines, technical milestones, and cross-functional partners (clinical, R&D, regulatory, manufacturing).
• Drive the execution of the design control process: inputs/outputs, materials, architecture, risk management, and reviews, in close cooperation with R&D partners and service suppliers
• Oversee V&V strategy and execution, including preclinical testing and documentation traceability.
• Act as the main liaison with quality and regulatory partners, ensuring MDR/ISO 13485/14971 compliance.
• Support industrialization: manufacturability, supplier qualification, transfer process, and scale-up.
• Maintain design history and technical documentation (DHFs, protocols, V&V records).
• Mentor junior team members and promote best practices across documentation and development.

Profile

• 3–7 years’ experience in medical device development (preferably Class III / cardiovascular / structural heart).
• Background in Biomedical, Mechanical Engineering, or Materials Science; advanced degree preferred.
• Deep understanding of design control, V&V methods, preclinical testing, and system-level development.
• Familiar with EU MDR, ISO 13485, ISO 14971; regulatory submission experience is a plus.
• Strong project management, documentation, and cross-functional collaboration skills.
• Fluent in English; Italian proficiency highly desirable.

What We Offer

• A key role in a mission-driven startup  advancing a next-generation therapy for TR .
• High ownership, direct impact, and close collaboration with world-leading experts in structural heart.
• Competitive compensation and flexible/hybrid working arrangements.