System Engineer to Prevas Uppsala

Are you a System Engineer looking to join a workplace that emphasizes innovation, culture, and their employees? Do you want to work with a team of skilled consultants and have the opportunity to grow and be challenged? If so, the consultant role at Prevas might be the perfect fit for you!

About Prevas
Prevas is a leading consulting company specializing in product development within among other things the life science industry and development of medical devices and IVD instruments. We aim to create groundbreaking solutions that improve the quality of life for people worldwide. Our experience in life science andtech product development, with a focus on risk-based development, is also applicable to other industries aswell, where reliability and quality are key factors.

About the Team Role
As a System Engineer at Prevas Uppsala, you will have a diverse consulting role, being part of a team of four Systems Engineers with different expertise. The team is self-driven and highly competent.

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. Your responsibilities will include analyzing and interpreting technical requirements, translating them into concrete technical solutions in collaboration with domain experts.

At Prevas Uppsala, we collaborate with cross-functional teams to ensure that products meet user needs, quality standards, and regulatory requirements. You will be in charge of conducting risk assessments and managing the risk management process during product development. Additionally, you will be responsible for creating and maintaining technical documentation according to applicable standards and guidelines.

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.

Knowledge and interest in regulations and standards, and how these are applied to put products on markets in different geographic regions is a bonus. Previous experience in a regulated environment and knowledge of FDA requirements and European medical technology legislation is also considered advantageous.

We look forward to receiving your application!
This recruitment is managed by Ed:Za group. We do not accept applications via email, but if you have any questions, you can contact charlotte.hoffstrom@edzagroup.se.

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