Medical Device Systems Engineer — Robotics & Compliance

Distalmotion SA; Schweiz; Remote; CHF 90.000 - 130.000; Vollzeit

Benefits dieser Stelle

Innovative environment

Fast-growing company

Structured onboarding

Autonomy

Zusammenfassung

Distalmotion SA is seeking a Systems Engineer to support the development and lifecycle management of a complex medical device. You will ensure the integrity of the Design History File (DHF) across stages, from regulatory requirements to subsystem activities.

You will collaborate with cross-functional teams, define the system architecture, support risk management, and contribute to reprocessing, biocompatibility, usability, and other engineering initiatives. English required; French/German a plus.

Qualifikationen

• Master’s degree and 3+ years of medical device experience.
• Experience with regulatory requirements and Design History File (DHF) management.
• Knowledge of IEC 60601, ISO 14971, ISO 13485, ISO 10993 and related standards.
• Familiarity with requirements management tools and cross-functional collaboration.

Aufgaben

• Collaborate with cross-functional teams to translate stakeholder needs into verifiable system requirements.
• Contribute to system architecture evolution and overall system design for a complex medical device.
• Ensure consistency between system requirements, subsystem activities, and integration.
• Support user testing of prototypes to validate design assumptions.
• Maintain alignment between regulatory requirements, the DHF, and applicable standards.
• Plan and execute system engineering activities supporting releases and roadmap.
• Support risk management activities with the Risk Manager.
• Contribute to cross-functional activities like reprocessing validation and biocompatibility.

Kenntnisse

Systems engineering

Requirements engineering

System architecture

Regulatory thinking

Ausbildung

Master’s degree in electrical/ mechanical engineering

Tools

Polarion

Jobbeschreibung

Distalmotion SA is seeking a Systems Engineer to support the development and lifecycle management of a complex medical device. You will ensure the integrity of the Design History File (DHF) across stages, from regulatory requirements to subsystem activities.

You will collaborate with cross-functional teams, define the system architecture, support risk management, and contribute to reprocessing, biocompatibility, usability, and other engineering initiatives. English required; French/German a plus.