Entwicklungsingenieur
Core
Develop, verify, and maintain active medical devices and device software across the entire product lifecycle for lung function and cardiopulmonary diagnostics.
Role type
Senior IC medical device development engineer
Builds
Active medical devices and medical device software
Domain
MedTech / Healthcare diagnostics
Deliverable
production ML models | product features
Required skills
Medical device development lifecycle, MDR (EU) 2017/745 compliance, technical documentation, verification and validation, risk management, regulatory standards knowledge, hardware and software development understanding
Preferred skills
Active medical device development, IEC 62304 software processes, IEC 62366 usability engineering, international regulatory submissions (FDA, NMPA, CDSCO), sensorics, embedded systems, measurement technology, respiratory diagnostics
Technologies
MDR (EU) 2017/745, EN ISO 13485, EN ISO 14971, IEC 62304, IEC 62366
Responsibilities
Participate in development, verification, and continuous improvement of active medical devices and software; Create and maintain development-related documentation per MDR and relevant standards; Plan and execute development projects with QM department; Support transition of new product concepts to marketable devices; Conduct risk analyses, usability evaluations, and verification/validation activities; Optimize technical solutions for existing products; Evaluate technical and regulatory requirements; Create technical documentation for development and approval projects; Participate in change control processes and corrective/improvement actions; Collaborate with external development partners and notified bodies; Support product testing and creation of test protocols; Contribute to international approval projects and technical preparation of product documents.
Seniority
Mid-to-Senior, hands-on IC