Software Quality Engineer Pisa

Software Quality Engineer
Pisa
Toscana, Pisa

Company Description Wearable Robotics is a leading manufacturer of robotic devices and exoskeletons for rehabilitation, movement assistance, and human capacity augmentation.

Based in Pisa, Italy, we specialize in developing high-efficiency wearable robots for motor function recovery, load handling or walking assistance.

Our innovative products are designed for use in various fields, such as industry for force amplification and in the medical field for neuromotor/functional rehabilitation systems.

Role Description This is a full-time on-site role for a Software Quality Engineer at Wearable Robotics in Pisa, Italy.

The Software Quality Engineer will be responsible for ensuring the quality and reliability of our software products by conducting quality assurance testing, developing test cases, and working closely with the software development team.

Responsibilities The ideal candidate will have a strong background in SW design and control within the medical device industry.

The Quality Software Engineer responsibilities are:

Management of the Design and Control of a medical device SW. Collaborate closely with product development for the preparation of a medical device SW V&V ensuring compliance with relevant medical device standards such as ISO 13485 and IEC 62304. Contribute to the maintenance of comprehensive documentation for software development, testing, validation, and maintenance processes, ensuring full compliance with regulatory requirements. Definition of SW requirements from a quality point of view and tests case design to verify SW functionality. Work cross-functionally to resolve SW technical issues. Support Regulatory Affairs in creating submissions and responding to submission inquiries. Assist in the implementation and regulation of ISO and FDA requirements. Author of technical and quality management system documents with clarity and consistency. Support for non-conformities resolution and changes management impacting QMS and product. Participate in internal audits, including preparation and direct interaction with auditors. Monitor priorities and track progress against the agreed schedule. Qualifications Master degree in Biomedical Engineering, Robotics, Computer Science or an equivalent technical degree. Experience: at least 4 years of experience in SW Quality within the medical device industry. Understanding of SW modules as well as the overall architecture of the solution. Strong attention to detail and excellent communication skills. Ability to apply medical standards such as ISO 13485, ISO 14971, and FDA Quality System Regulations, particularly in design controls and optimization. Familiarity with FDA guidance documents, as well as ISO standards related to quality and the medical device industry. Experience with design control and risk management from early design and development through commercialization of product. Knowledge and strong understanding of FMEAs, Root Cause Analysis, CAPAs, Non-Conformity management and SW Validation.

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