Mechanical Engineer

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

About Artidis

Artidis is a pioneering clinical stage health technology company that aims to set the gold standard in tissue analysis and therapy optimization. By combining its nanotechnology platform for rapid tissue analysis with a holistic data solution, Artidis accelerates drug discovery, tissue engineering, and personalized treatment. Artidis focuses its research and development efforts on solid tumors to enhance responses to chemo, immuno, and cell therapies, driving precision in cancer care.

Job Purpose

The Mechanical Engineer provides mechanical engineering expertise for the development, design, and industrialization of Artidis products and technologies. The role independently addresses complex technical challenges from specification and concept development through prototyping, verification, and transfer to production, applying broad expertise in mechanics, manufacturing, and applicable standards. In addition, the Mechanical Engineer serves as a technical reference within the hardware team, supports and mentors junior engineers, and contributes to the planning and coordination of mechanical engineering work packages.

Duties and Responsibilities

• CAD mechanical part modeling, assembling and drawing, using Autodesk Inventor and Vault (PDM).
• Create and review detailed technical plans, specifications and layouts for mechanical components and assemblies.
• Ensure all designs adhere to ISO GPS standards and applicable regulatory/design specifications.
• Requirements engineering: define technical requirements and design specifications for mechanical parts and assemblies.
• Collaborate closely with embedded and software engineering teams to integrate mechanical designs with other system components.
• Design, build and test mechanical prototypes (devices, add-ons, equipment, tools) to validate functionality and design choices.
• Create design verification tests; develop related test procedures.
• Lead and contribute to design reviews, providing expert feedback and driving design improvements.
• Perform necessary modifications and revisions to designs based on feedback.
• Manage change control of mechanical parts and assemblies through the PDM system.
• Generate production data and support the transition from development to manufacturing.
• Communicate and coordinate with suppliers and manufacturers regarding part and assembly production, sourcing and quality issues.
• Create documentation to be submitted for FDA (US) or Notified Body (EU) approval for medical devices.
• Ensure the maintenance and troubleshooting of prototypes to keep them operational.
• Document all design processes, revisions and specifications clearly and accurately.
• Mentor and provide technical guidance to junior mechanical engineers, including review of their designs.
• Contribute to project planning for mechanical work packages: define scope, milestones and resource needs, and coordinate timelines with cross-functional teams.

Qualifications

• Bachelor's or master's degree in Mechanical Engineering or Systems Engineering; specialization in Mechanical Design is an advantage.
• At least 5 years of professional experience in mechanical design and development, ideally including integrated electro-mechanical systems.
• Previous experience developing medical devices, with knowledge of regulated processes (ISO 13485 quality management, ISO 14971 risk management).
• Strong knowledge of ISO GPS.
• Proven experience with machined parts, welded assemblies, plastic injection and 3D-printed components (plastic and metal).
• Proficient in Autodesk Inventor and Vault, with the ability to review and validate the work of other engineers.
• Strong ability to create, review and validate accurate technical drawings and CAD assemblies with attention to detail.
• Strong knowledge in Design Controls, documentation for FDA or Notified Body submissions.
• Hands-on experience troubleshooting and maintaining prototypes.
• Proven problem-solving skills and the ability to investigate and implement efficient mechanical solutions.
• Demonstrated ability, or clear potential, to mentor and coach junior engineers, providing technical guidance and design review feedback.
• Some exposure to, or strong interest in, project coordination: planning mechanical work packages, tracking milestones and coordinating with cross-functional teams and external suppliers.
• Self-initiative, high level of responsibility and strong communication skills.
• Fluent in English; German is a strong advantage.

Working Conditions

The environment is a typical start-up with an intrinsically motivated international team. Our company is an excellent place for rapid advancement and offers a promising opportunity to learn and share know-how in a very agile environment. The position requires the employee to go the extra mile when needed. We are looking for a team player who appreciates direct communication. The effort is rewarded with challenging tasks, the possibility to take responsibility, a highly driven team, and work serving a significant purpose. The job position comes with a competitive salary and a bonus for outstanding performance.