Systems Engineer

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:

• A dynamic, innovative environment with cutting-edge medical technology that is shaping the future of robotic surgery.
• Fast-growing Company where innovation meets agility.
• Structured onboarding program and training, ensuring a confident start.
• High degree of autonomy and flexibility.