Senior Systems Engineer

Distalmotion

Épalinges, Switzerland

About Senior Systems Engineer:

As Senior Systems Engineer at Distalmotion, you will play a critical role in the development and life cycle management of a complex medical device. You will be responsible of defining and maintaining product requirements and system architecture, 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 a wide range of system level activities of our Dexter surgical platform.Those activities comprise validation efforts, usability testing and complaints investigation.

Duties and Responsibilities:

Systems Engineering:

Define system-level requirements and user interface requirements in collaboration with cross-functional teams;
Responsible of the development of system level architecture;
Monitor the consistency between sub-system level activities and system level ones;
Contribute to the consistency between regulatory requirements and our DHF with focus on the medical electrical equipment standards series;
Contribute to system-level development planning, reviews, and reports;
Contribute to the definition of stakeholder requirements in collaboration with the product team;
Contribute to delivering product releases in a timely manner according to the Company’s product roadmap;
Contribute to road-mapping activities and to project and product definitions for System level activities;
Contribute to risk management activities, in close collaboration with the Risk Manager.

Other Tasks:

Contribute to design validation activities, demonstrating coverage of stakeholder requirements;
Contribute to usability (human factors) engineering activities: identification and assessment of potential use errors and risks through formative and summative evaluations;
Support, when needed, internal product-level investigations.

Work Experience and Education requirements:

Master’s degree in electrical engineering, mechanical engineering, microengineering (or similar);
5+ years’ experience in a similar position in the medical device field;
Familiar with applicable standards for medical devices: e.g. IEC 60601-1, ISO 14971, IEC 62366.

Knowledge, Skills & Abilities required:

Detail oriented with strong analytical skills;
Demonstrable experience in working with other engineering disciplines and other Company functions including Product Management, QA, and Operations;
At ease with requirements management tools (e.g. Polarion, JAMA, Doors or similar);
Strong verbal and written communication, and documentation skills;
Professional oral and written English; French and German a nice to have.

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