Job Description

About Us

BellaSeno GmbH, founded in 2017, is a disruptive technology start-up based in the BioCity Leipzig (Alte Messe). BellaSeno develops bioresorbable scaffolds and leverages 3D printing to create highly complex structures that open up new possibilities in medical technology. As a dynamic and innovative start-up, we offer a varied range of responsibilities in a modern work environment with flat hierarchies and short decision-making paths.

We are dedicated to developing state-of-the-art implant technologies that enhance patient safety, performance, and quality of life. By combining excellent design with rigorous regulatory compliance, we bring safe, effective, and high-quality medical devices to market.

The Role

We are seeking a highly skilled Head of Design & Development to lead our design team with a primary focus on design control and project management. This role is essential in ensuring that all design activities are executed in compliance with ISO 13485, FDA 21 CFR Part 820, and related regulatory standards.

As the Head of Design & Development, you will own the design control process, ensure documentation quality, and manage complex projects from concept to commercialization. You will also lead a team of engineers and designers, working closely with cross-functional partners to deliver safe, innovative, and reliable medical devices.

Key Responsibilities

Lead and maintain robust design control processes, ensuring full regulatory compliance across all projects. Oversee and manage multiple development projects, ensuring timelines, budgets, and quality standards are met. Develop, implement, and improve design standards, procedures, and technical documentation (e.g. design history files, risk management files, test reports). Act as the primary liaison between design, manufacturing, regulatory, quality, and external stakeholders. Drive structured project management: define milestones, allocate resources, monitor project risks, and report progress to leadership. Mentor and manage the design team, fostering a culture of accountability and continuous improvement. Conduct and support usability testing and stakeholder engagement (surgeons, patient groups, partners). Guide the creation of CAD models, engineering drawings, and simulations (FEM/CFD) to support design validation. Ensure design feedback from customers and stakeholders is systematically captured and integrated. Report regularly to the CTO on project status, design control compliance, team performance, and strategic development initiatives.

Requirements / Qualifications

University degree in Biomedical Engineering, Mechanical Engineering, or related field; advanced degree preferred. 6+ years of professional experience in medical device design and development, ideally in the context of class III devices and/or 3D-printed implants. Proven expertise in design control, regulatory compliance, and documentation systems, ideally in the context of class III medical devices. Strong project management skills with the ability to lead multiple projects simultaneously. Familiarity with CAD modeling, engineering design, and simulation tools (FEM/CFD). Experience with MDR, FDA requirements and other relevant standards and giudelines Excellent organizational, leadership, and communication skills. High proficiency in English (written and spoken); additional languages are an advantage. Experience in international and cross-functional collaboration.

What We Offer

A leadership position with direct responsibility for design control and project management excellence. The opportunity to shape innovative implant technologies from early-stage concepts to market launch. A collaborative, international, and mission-driven work environment. Competitive compensation and benefits package. Opportunities for professional development and career progression.
Art der Stelle: Vollzeit

Gehalt: 60.000,00€ - 70.000,00€ pro Jahr

Leistungen:

Betriebliche Weiterbildung Firmenhandy Flexible Arbeitszeiten Homeoffice-Möglichkeit Kostenlose Getränke
Arbeitsort: Zum Teil im Homeoffice in 04103 Leipzig