SelfD Technologie GmbH is a medical device research and development company that is based in Leipzig, Germany. Our mission is to develop innovative, user-friendly and discreet solutions to detect infectious diseases and to become a worldwide innovation leader in preventive medicine solutions.
In recent years, Leipzig has become a leading research and development site for the biotech and medtech industries. The BIO CITY Leipzig is considered one of Europe’s most modern centers for biotechnology and biomedicine.
At the earliest possible date, we are looking for a SENIOR MEDICAL DEVICE ENGINEER with extensive experience in design of in vitro Diagnostics (IVD) devices and the transition to manufacturing (injection molding). The device will combine micro-heating and microfluidic manipulation so experience in these areas is a definite plus. Since the product will adhere to ISO 13485 experience in this standard is essential in setting up our technical documentation for regulatory approval.
- Design (CAD and physical prototyping) of functional model and prototype iterations.
- This involves optimization of micro heating solution and microfluidic transport of liquids.
- Ensuring such design is easy and affordable to produce and assemble.
- Guiding and supporting a small team of engineers and other scientist in the needed R&D work.
- Leading the transfer of the functional model to the prototype.
- Making sure that the final prototype will be certified under ISO 13485 after final clinical evaluation.
- Aiding in conformity of product of relevant ISO standards (ISO 23640, ISO 18113, ISO14971 etc.)
What we look for:
- A deep work experience in the field of medical device design (ideally in vitro Diagnostics).
- Deep knowledge regarding documentation and the design history file
- Excellent knowledge of necessary software (Excel and CAD software specifically).
- Good knowledge in the ISO standards mentioned above.
- Fluent English (written and spoken).
- Experience in bringing a product from the stage of a functional model to that of a final prototype ready for small series production and clinical validation.
- Experience in injection molding and nucleic acid amplification techniques are definite advantages.
What we offer:
SelfD Technologie GmbH (facebook.com/selfdiagnostics.eu
) is a company that values leadership, creativity, teamwork and initiative. You will find flat hierarchies, a committed and highly motivated team as well as a modern working environment. At SelfD Technologie GmbH you will have the opportunity to contribute to a project that will change an entire industry and helps improve living conditions across the planet.
Please send your curriculum vitae including certificates, references and a motivation letter (max. 1 page) in German or English to email@example.com