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.