One of the most up and coming & innovative medical device companies in the Baden-Württemberg region is looking for a Snr R&D Engineer. P.s, you need to be in the medical device industry to be qualified for this role. Responsibilities Lead and participate in the design, development, and testing of new medical devices, ensuring compliance with regulatory standards and industry best practices. Drive innovation within the R&D team by staying abreast of emerging technologies, conducting feasibility studies, and proposing novel approaches to product development. Oversee the prototyping process, including the fabrication of prototypes, conducting design verification and validation testing, and implementing design improvements based on test results. Maintain accurate and detailed documentation throughout the product development lifecycle, including design specifications, test protocols, and regulatory submissions, to ensure compliance with regulatory requirements (e.g., ISO 13485, FDA QSR, MDR). Provide technical guidance and mentorship to junior engineers, fostering a culture of learning and innovation within the R&D team. Qualifications: Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or related field; Master’s degree or PhD preferred. ISO 13485. MDR. Minimum of 5 years of experience in medical device product development, with a proven track record of successfully bringing products from concept to commercialization. Strong understanding of relevant regulatory requirements and standards (e.g., ISO 13485, FDA QSR, MDR) pertaining to medical device development. Excellent project management skills, with the ability to prioritize tasks, manage resources effectively, and deliver results within tight deadlines. Exceptional problem-solving abilities and a keen attention to detail. Please apply if you're interested.