Human Xtensions is a rapidly growing startup, developing breakthrough technology in the field of robotic Minimally Invasive Surgery (MIS). We’re looking for an awesome system engineer to join our system engineering team that is reshaping MIS.
The system engineer will play a key role in the development efforts of surgical robotic systems in both a scale-up journey and in developing of the next generation.
- Lead the development of system and sub-system level requirements and specifications for a multidisciplinary system
- Participate in development of product concept and definition of architecture
- Drive technical feasibility research activities to define unmet user needs
- Perform risk management activities at all levels throughout product lifecycle
- Provide technical leadership in system design, integration, verification, validation and improvements
- Ensure system requirements have been properly implemented, verified and validated
- Ensure systems design and documentation meet all safety and regulatory compliance
- Contribute to establishing the best engineering practices in the full product development cycle for the R&D team
- Lead root cause analysis in failure investigation activities
- Participate in regulatory submissions and audits (FDA and EU )
- 6+ years of experience in development of multi-disciplinary products
- 2+ years system engineering experience in the medical device field
- B.Sc / M.Sc Degree in mechanical or electrical engineering from a leading university
- Master multidisciplinary system including mechanics, electronics and software
- Excellent knowledge of system lifecycle phases and design control processes
- Familiar with systems engineering processes, in particular system requirements methodologies.
- FDA Quality System Regulations , ISO 13485, ISO 14971 understanding with a focus on design controls and risk management
- Excellent documentation skills.
- Able to collaborate across technical and non-technical disciplines. Good team player
- Able to work in start-up environment, with changing priorities and a high workload. Multi-Tasker
- M.Sc in system engineering
- Experience in medical software development
- Experience in EMC and electrical safety certifications