System Engineer, Medical Device — Full Lifecycle Ownership

Navari; Göteborgs kommun; On-site; SEK 900,000 - 1,300,000; Full time

Job summary

Navari Surgical is seeking a System Engineer to take broad technical ownership of the Navari surgical system, from design and development through clinical investigations, regulatory activities and market introduction, to post-market support and improvements.

You will work across mechanics, electronics, software, clinical needs and regulatory requirements, translating real-world requirements into robust technical solutions, maintaining system-wide traceability, and collaborating with engineering,

Qualifications

• Academic degree in engineering (mechanical, automation, electronics, software or biomedical).
• 5+ years of experience as a System Engineer or in a similar role.
• Experience in the medical device industry or other regulated products.

Responsibilities

• Take overall responsibility for system functionality, safety and security.
• Plan and coordinate system-level risk management.
• Define and maintain system requirements with traceability through verification and validation.
• Develop system-level test methods and acceptance criteria.
• Define interfaces between mechanical, electronic and software subsystems.
• Lead implementation of new or changed system requirements and coordinate activities across subsystems.
• Evaluate technical results and feedback from clinical investigations and user focus groups.
• Contribute to regulatory activities and develop product technical documentation.
• After market introduction, provide technical input to customer communication and training and maintain product documentation.

Skills

Systems thinking

Ownership

Cross-disciplinary collaboration

Communication skills

Startup/fast-moving environment

Education

Engineering degree

Job description

Navari Surgical is seeking a System Engineer to take broad technical ownership of the Navari surgical system, from design and development through clinical investigations, regulatory activities and market introduction, to post-market support and improvements.

You will work across mechanics, electronics, software, clinical needs and regulatory requirements, translating real-world requirements into robust technical solutions, maintaining system-wide traceability, and collaborating with engineering,