System Development Specialist
3 weeks ago
At Prevas, we believe that technology can make the world a better place. To achieve this, we need talented individuals like you to join our team. As a System Engineer, you will be responsible for the technical leadership and execution of product development projects from concept to launch. Your role will involve analyzing and interpreting technical requirements, translating them into concrete technical solutions in collaboration with domain experts. You will also be responsible for ensuring compliance with ISO 13485 and other relevant standards and regulations. Our team is self-driven and highly competent, and we collaborate with cross-functional teams to ensure that products meet user needs, quality standards, and regulatory requirements. We are looking for a motivated and experienced System Engineer with expertise in the development of medical technology products and comprehensive knowledge of relevant standards such as ISO13485, IEC62304, IEC60601, etc.
About the Job
- Develop and implement technical solutions to meet customer requirements
- Analyze and interpret technical requirements to ensure compliance with regulations
- Collaborate with domain experts to ensure that products meet user needs, quality standards, and regulatory requirements
- Conduct risk assessments and manage the risk management process during product development
- Create and maintain technical documentation according to applicable standards and guidelines
About You
- Relevant university degree in engineering or a similar field
- Experience in requirements engineering from both user and system perspectives, designing system architecture based on these requirements
- Experience working with risk-driven processes, particularly in dealing with technical risks
- Background in engineering or a similar field, with a strong understanding of the interaction between electronics, mechanics, and software
- Strong technical project management skills, with the ability to handle multiple projects simultaneously and meet deadlines
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