Senior Mechanical Engineer, Medical Devices (FDA Class II)

Tobii Dynavox®; Stockholms kommun; Vor Ort; SEK 700.000 - 950.000; Vollzeit

Zusammenfassung

Tobii Dynavox is seeking a Senior Mechanical Engineer in Sweden to lead system-level designs and prototype fabrication for our FDA Class II AAC devices. You will model, draw, and assemble parts in SolidWorks, collaborating with a global team including manufacturing in China and partners in the USA and Sweden.

Responsibilities include design reviews, BOM creation in the QMS, risk management, and hands-on prototyping to advance concepts to production.

Qualifikationen

• Bachelor’s Degree in Mechanical Engineering is required.
• 5–10+ years developing complex injection molded components (plastic/metal).
• Experience with design for manufacturability and assembly is required.
• Proficient with SolidWorks and 3D modeling.
• Experience with creating parts, assemblies, and drawings.
• Familiarity with FDA Class II medical devices is a plus.

Aufgaben

• Conceptual and detailed design of molded components (plastic and metal).
• Generate parts, assemblies, and drawings using SolidWorks.
• Develop innovative solutions and hands-on prototyping.
• Collaborate with mechanical, electrical, product, and QA teams to meet timelines and budgets.
• Lead design reviews with internal and external stakeholders.
• Develop BOMs and part numbers in the QMS system.
• Contribute to risk management.

Kenntnisse

Detail part design and drawings

Design for manufacturability

SolidWorks

3D solid and surface modeling

MS Office/Teams

Team collaboration

Problem solving

Safety/compliance awareness

Ausbildung

Bachelor’s Degree in Mechanical Engineering

Tools

Arena

QMS system

CAD data management

Jobbeschreibung

Tobii Dynavox is seeking a Senior Mechanical Engineer in Sweden to lead system-level designs and prototype fabrication for our FDA Class II AAC devices. You will model, draw, and assemble parts in SolidWorks, collaborating with a global team including manufacturing in China and partners in the USA and Sweden.

Responsibilities include design reviews, BOM creation in the QMS, risk management, and hands-on prototyping to advance concepts to production.