Job Title: Senior R&D Engineer – Medical Devices Location: Baden-Württemberg, Germany Job Type : Full time, Permanent A pioneering medical device company specializing in innovative cardiovascular and Class III implantable devices is seeking an experienced Senior R&D Engineer to join its growing engineering team in Germany. This position offers the opportunity to play a key role in the design, development, and clinical evaluation of cutting-edge products that improve the lives of patients worldwide. The ideal candidate will have at least 4–5 years of experience in the medical device industry, demonstrating both technical excellence and leadership potential. Experience with similar products is a strong plus. This role provides a clear development pathway toward a Team Lead R&D position. Responsibilities: Lead and participate in the design, development, and optimization of advanced medical devices, particularly in the cardiovascular and interventional domains (e.g., PTCA/PTA). Drive innovation in design methodologies, prototyping, and experimental validation to address complex biomechanical and physiological challenges. Conduct feasibility studies, risk analyses, and verification/validation tests. Collaborate closely with Quality Management and Regulatory Affairs to ensure full compliance with ISO 13485, ISO 14971, MDR, and FDA requirements. Support and prepare for audits, ensuring that design control documentation and risk management files meet regulatory standards. Formulate and manage detailed project plans covering design, development, risk management, quality assurance, and regulatory pathways. Coordinate effectively with Production, Supply Chain, Quality, and Regulatory teams to ensure smooth technology transfer from R&D to large-scale manufacturing. Work directly with clinicians and key opinion leaders to translate clinical needs into engineering solutions and incorporate feedback into product design. Analyze and improve development and production processes for enhanced efficiency and reliability. Support equipment qualification and process validations to ensure robust, reproducible manufacturing. Develop and standardize testing methodologies for verification and validation activities. Prepare comprehensive technical documentation, including design history files, technical reports, risk analyses (DFMEA, PFMEA), and validation studies. Maintain meticulous records of design inputs, materials, fabrication processes, and inspection methodologies to ensure traceability and compliance. Requirements: Degree in Engineering (e.g., Medical, Mechanical, or Process Engineering) or a related field. Minimum 4–5 years of experience in product design, development, and manufacturing within the medical device industry (Class III preferred). Strong proficiency in CAD software (preferably SolidWorks) and familiarity with manufacturing processes. In-depth knowledge of ISO 13485, ISO 14971, MDR, and FDA regulations. Experience working at the R&D/Quality interface, with an understanding of audit preparation and design control documentation. Excellent analytical and problem-solving skills, with a structured and solution-oriented approach. Demonstrated leadership potential and the ability to contribute to the structural development of the engineering department. Strong communication and teamwork abilities; capable of working cross-functionally in a dynamic, international environment. Good command of both German and English (spoken and written). Experience in the cardiovascular field is a plus, but not mandatory. Please reach out to emily.james@skillsalliance.com for further detail.