(Senior) R&D Engineer (m/f/d)

You develop products and processes and create the associated documentation in compliance with applicable standards.

You contribute to the continuous improvement of production processes and coordinate the creation of relevant work instructions.

You participate in the design of product components in line with design inputs and develop the required design outputs.

You collaborate with interdisciplinary teams within product development, such as Regulatory Affairs, Quality Assurance, Production, and Purchasing.

You develop test strategies, conduct experiments, and interpret and analyze the results.

You take on sub-project leadership for selected topics.

You have successfully completed a technical degree in the field of medical engineering and have at least 4 years of professional experience as a development or test engineer.

You have already gained hands-on experience with the development process in accordance with ISO 13485 and are familiar with medical device testing standards (e.g. ISO 10555, ISO 25539).

Ideally, you have knowledge of FDA requirements for stent-specific testing.

You are proficient in using CAD systems to create technical drawings or test fixtures.

You have experience in prototype development and are equally interested in ensuring a successful knowledge transfer to serial production.

Terms such as GxP, Design V&V, PFMEA, OQ, PQ, and DTP are very familiar to you from your previous work.

You have experience in project management of development projects, including planning, status tracking, and clearly communicating project status to management.

You can switch effortlessly between German and English in daily business.

You stand out through excellent problem-solving skills, a high level of independence, and strong communication and teamwork abilities.