As Systems Engineer at Distalmotion, you will play a critical role in the development and life cycle management of a complex medical device. You will support the definition of product requirements, ensuring the integrity of the Design History File (DHF) across all stages, from regulatory requirements to subsystem-level activities. Your role will be also to contribute to activities beyond core systems engineering, including reprocessing, biocompatibility, usability, and other cross-functional engineering initiatives.
Duties and Responsibilities
Systems Engineering
• Collaborate with cross-functional teams to capture stakeholder, clinical, business, and regulatory needs, and translate them into clear, complete, and verifiable system requirements.
• Contribute to the definition and evolution of the system architecture and overall system design for a complex medical device.
• Ensure consistency between system-level requirements, subsystem development activities, and system integration.
• Organize and support user testing of system prototypes to collect stakeholder feedback, validate design assumptions, and contribute to the refinement of the system design.
• Contribute to maintaining alignment between regulatory requirements, the Design History File (DHF), and applicable medical device standards, including the IEC 60601 series.
• Contribute to the planning and execution of system engineering activities supporting product releases and the product roadmap.
• Support risk management activities in collaboration with the Risk Manager.
Other Tasks
• Contribute, as needed, to cross-functional engineering activities such as reprocessing validation, biocompatibility assessments, labelling, Instructions for Use (IFU) development and maintenance, and other product development initiatives.
Requirements
Work Experience and Education requirements
• Master’s degree in electrical engineering, mechanical engineering, microengineering (or similar).
• 3+ years’ experience in a similar position in the medical device field.
• Previous experience as a Systems Engineer developing robotic-assisted surgical systems is a strong plus
Knowledge, Skills & Abilities required:
• Understanding of systems engineering principles, including requirements engineering, system architecture, system integration, and verification.
• Ability to write clear, complete, and testable system requirements.
• Knowledge of medical device design controls, risk management, and applicable standards (e.g., IEC 60601 and collaterals, ISO 14971, ISO 13485, ISO 10993, ISO 17664 series).
• Familiarity with requirements management tools (e.g., Polarion) is a must.
• Strong analytical and problem-solving skills, with the ability to investigate complex technical issues.
• Excellent communication and collaboration skills, with the ability to work effectively in multidisciplinary teams.
• Ability to manage multiple priorities and adapt to evolving project needs.
• Interest in contributing to cross-functional engineering activities such as reprocessing, biocompatibility, and prototype evaluation.
• Professional oral and written English; French and German a nice to have.
Benefits
What we offer
Distalmotion is a global MedTech company with a mission to empower access to the benefits of robotic surgery by simplifying operations with its DEXTER robot. The company aims to broaden access to robotic surgery for more surgeons and sites of care globally, including hospital outpatient departments (HOPDs) and ambulatory surgical centers (ASCs), to increase the number of patients who benefit from best-in-class minimally invasive care. Well-suited to any size OR, DEXTER is easily moved, quickly set up, and seamlessly integrated into existing procedures. DEXTER is commercially available in the United States and Europe.
The company is headquartered in Lausanne, Switzerland with a US office in Cleveland, Ohio.
