System Engineer

2 weeks ago


Uppsala, Uppsala, Sweden Prevas Full time
About the Role

We are seeking a highly skilled System Engineer to join our team at Prevas. As a System Engineer, you will be responsible for the technical leadership and execution of product development projects from concept to launch. You will work on developing and implementing processes to ensure compliance with ISO 13485 and other relevant standards and regulations.

Key Responsibilities
  • Analyze and interpret technical requirements, translating them into concrete technical solutions in collaboration with domain experts.
  • Conduct risk assessments and manage the risk management process during product development.
  • Create and maintain technical documentation according to applicable standards and guidelines.
  • Collaborate with cross-functional teams to ensure that products meet user needs, quality standards, and regulatory requirements.
About You

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. You are a team player with excellent communication skills, contributing to successful collaborations both internally and externally.

In addition to this, we would like you to have:

  • A 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.
  • A background that has evolved from an engineering role to a systems role, understanding 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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