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 skilled and motivated

Senior Design Engineer

to join our growing D&D team. In this position, you will design and develop both

custom-made

and

off-the-shelf

bioresorbable implants, working closely with surgeons, engineers, and regulatory experts. You will also contribute to

usability engineering

, ensuring that our products meet the needs of clinical users and patients alike. The role combines creative 3D design, structured documentation, and user-centered product development.

Key Responsibilities

Design and develop

custom-made and off-the-shelf implants

, from concept to release. Collaborate directly with

surgeons and clinical partners

to translate anatomical and functional requirements into implant designs. Create and optimize CAD models, engineering drawings, and 3D printed prototypes. Prepare and maintain

design documentation

(Design History Files, risk management files, usability reports, test plans, and verification documentation). Support

design control and usability engineering activities

in compliance with ISO 13485, ISO 14971, and FDA 21 CFR Part 820. Conduct design reviews, verification, and validation activities. Support or substitute the

Head of Design & Development

in organizational and project-related tasks when required. Develop and maintain

digital workflows and customization tools

to enable efficient, scalable implant design. Contribute to

usability testing

and the evaluation of prototypes with surgeons and other stakeholders. Collaborate with manufacturing, quality, and regulatory teams to ensure manufacturability, safety, and compliance.

Qualifications

University degree in Biomedical Engineering, Mechanical Engineering, Industrial Design, or a related field. 2–5 years of experience in

medical device design and development

, ideally involving 3D printing, implants or bioresorbable materials. Strong proficiency in

Rhinoceros 3D

; experience with automation or scripting (e.g., Python, Grasshopper) is a plus. Familiarity with

design control, usability engineering

, and relevant regulatory standards (ISO 13485, ISO 14971, FDA 21 CFR Part 820). Understanding of

anatomy

and experience working with medical imaging data (DICOM) is a plus. Strong communication and teamwork skills, with experience collaborating with clinical partners.

Leadership experience

or demonstrated potential for team coordination is an advantage. Fluent in English (written and spoken); German is an advantage.

What We Offer

The opportunity to work at the intersection of

medical design and 3D printing

with

deputy leadership responsibility.

A dynamic start-up culture with flat hierarchies and fast decision-making. Direct interaction with surgeons and involvement in both

custom-made

and

standardized implant development

. Competitive compensation and benefits package. Opportunities for professional development and growth in an innovative medtech company.
Art der Stelle: Vollzeit

Gehalt: 50.000,00€ - 60.000,00€ pro Jahr

Leistungen:

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