Mechanical Engineer - Medical Devices & Prototyping

Artidis; Basel; Vor Ort; CHF 90.000 - 130.000; Vollzeit

Zusammenfassung

Artidis is a Basel-based health technology company seeking a senior Mechanical Engineer to lead the design, prototyping, and industrialization of our tissue-analysis devices. You will collaborate with hardware, embedded and software teams to translate concepts into robust hardware ready for manufacturing.

The role requires strong experience with ISO 13485/14971, FDA/Notified Body submissions, and hands-on prototype testing, with mentoring for junior engineers.

Qualifikationen

• Bachelor's or master's degree in Mechanical Engineering or Systems Engineering; specialization in Mechanical Design advantageous.
• At least 5 years of professional experience in mechanical design and development, ideally including integrated electro-mechanical systems.
• Experience developing medical devices with knowledge of ISO 13485 and ISO 14971.
• Strong knowledge of ISO GPS.
• Experience with machined parts, welded assemblies, plastic injection and 3D-printed components.
• Proficient in Autodesk Inventor and Vault, with the ability to review others' work.
• Ability to create, review and validate accurate technical drawings and CAD assemblies.
• Knowledge of Design Controls for FDA or Notified Body submissions.
• Hands-on experience troubleshooting prototypes.
• Proven mentoring ability for junior engineers.
• Exposure to project coordination: planning mechanical work packages and coordinating with cross-functional teams and external suppliers.
• Self-initiative and strong communication skills.
• Fluent in English; German is a strong advantage.

Aufgaben

• CAD mechanical part modeling, assembling and drawing using Autodesk Inventor and Vault (PDM).
• Create and review detailed technical plans and layouts for mechanical components and assemblies.
• Ensure designs adhere to ISO GPS standards and regulatory specifications.
• Define technical requirements and design specifications for mechanical parts and assemblies.
• Collaborate with embedded and software teams to integrate mechanical designs with other system components.
• Design, build and test mechanical prototypes to validate functionality and design choices.
• Create design verification tests and related procedures.
• Lead and contribute to design reviews and drive design improvements.
• Modify designs based on feedback and manage change control in the PDM system.
• Generate production data and support transition from development to manufacturing.
• Coordinate with suppliers and manufacturers regarding parts production and quality issues.
• Create documentation for FDA or Notified Body submissions.
• Maintain and troubleshoot prototypes.
• Document all design processes and revisions clearly.
• Mentor and provide guidance to junior engineers.
• Contribute to project planning for mechanical work packages and cross-functional timelines.

Kenntnisse

ISO GPS

Mechanical design

Regulatory knowledge

Mentorship

Problem solving

English

German advantage

Ausbildung

Bachelor's/Master's in Mechanical Engineering

Tools

Autodesk Inventor

PDM Vault

Jobbeschreibung

Artidis is a Basel-based health technology company seeking a senior Mechanical Engineer to lead the design, prototyping, and industrialization of our tissue-analysis devices. You will collaborate with hardware, embedded and software teams to translate concepts into robust hardware ready for manufacturing.

The role requires strong experience with ISO 13485/14971, FDA/Notified Body submissions, and hands-on prototype testing, with mentoring for junior engineers.