Systems Engineer

Distalmotion; Épalinges; Vor Ort; CHF 90.000 - 140.000; Vollzeit

Zusammenfassung

Distalmotion is seeking a Systems Engineer to drive the development and lifecycle management of a complex medical device. You will translate stakeholder needs into verifiable requirements and contribute to system architecture, ensuring DHF integrity across regulatory stages.

You will also support cross-functional activities including reprocessing, biocompatibility, labeling, and IFU development, with English as the working language and French/German a plus.

Qualifikationen

• Master’s degree in electrical or mechanical engineering or similar.
• 3+ years’ experience in a medical device role.
• Experience with robotic-assisted surgical systems is a strong plus.

Aufgaben

• Capture stakeholder, clinical, business, and regulatory needs into verifiable system requirements.
• Define and evolve the system architecture for a complex medical device.
• Ensure alignment between system requirements, subsystems, and integration.
• Organize and support user testing to collect feedback and refine the design.
• Maintain alignment of regulatory requirements with the Design History File and IEC 60601 standards.
• Plan and execute system engineering activities for product releases and the roadmap.
• Support risk management activities with the Risk Manager.
• Contribute to cross-functional engineering activities such as reprocessing and biocompatibility.

Kenntnisse

Systems engineering principles

Requirements engineering

System architecture

System integration

Verification

Analytical thinking

Communication

Collaboration

Multidisciplinary teamwork

Ausbildung

Master’s degree in electrical engineering

Tools

Polarion

Jobbeschreibung

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.

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.

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.