MEDICAL DEVICE DEVELOPER

SelfD Technologie GmbH is a research and development company located in Leipzig and operating in the field of life-sciences (in particular in the field of medical device development). SelfD Technologie GmbH is carrying out the research project “Development of an NAAT nucleic acid amplification technology as POCT rapid test for Chlamydia trachomatis and Mycoplasma genitalium for home use”. This is a joint project in which SelfD Technologie GmbH is cooperating closely with the Fraunhofer Institute for Cell Therapy and Immunology (IZI) and engineering companies in Saxony and the University of Tartu in Estonia. The project is funded by the Sächsische AufbauBank (SAB).

At the earliest possible date, SelfD Technologie GmbH is looking for a MEDICAL DEVICE DEVELOPER.

The ideal candidate for this role will come from a strong engineering background, with industry experience in research and development (with candidates with marketing experience being the preference). You must have worked on product development for medical device products; expertise in the area of IVD would be ideal. Manufacturing and validation experience would be an advantage.

The ideal candidate is responsible for performing routine and non-routine laboratory experiments for the optimization, verification and validation of IVD product(s), performs process optimization and validation, as well as product calibration and stability studies. Meets deadlines specified in overall project schedules.

Basic qualifications:

•  A Master Degree in Engineering or similar is required
•  2+ years of engineering experience with a leading medical device company preferred
•  Excellent knowledge and understanding of (new) product development and manufacturing in the medical devices/pharmaceutical industry
•  Experience with IVD and biological samples is preferred
•  Knowledge of 21 CFR 820, 21 CFR 11 and European regulations associated with the medical device industry
•  High understanding of GMP, Compliance, Validation Practices including the system development life cycle and Regulatory expectations
•  Experience working with an FDA regulated medical device and associated regulatory processes is desired.
•  Excellent problem solving skills
•  Proficient computer skills including Microsoft Word, Excel, Power Point, and Outlook
•  Strong project management skills
•  Technical understanding
•  Excellent verbal and written communication skills, including excellent presentation skills
•  Fluent in German and English

Additional skills:
Experience in the following areas would be an advantage:

•  Demonstrated working knowledge of IVD manufacturing.
•  Knowledge of molecular biology methods
•  Must be proficient with computers and office tools, experience with network infrastructure and configuration highly desired.
•  Familiarity with risk management tools;
•  Design for manufacturing
•  Human factors engineering
•  Quality and validation experience is advantageous

Please send your curriculum vitae with certificates, references and a motivation letter (max. 1 page) in English to info@selfdiagnostics.eu.