System Integration Engineer – Medical Devices
Join to apply for the System Integration Engineer – Medical Devices role at Xsensio
System Integration Engineer – Medical Devices
Join to apply for the System Integration Engineer – Medical Devices role at Xsensio
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We are seeking a highly skilled and motivatedSystem Integration Engineerspecializing in medical devices to join our dynamic team.
You will own thedevice system integrationprocess, driving it from specification definition through design, prototyping, testing, and manufacturing. This critical role involves integrating mechanical and electronic components, designing packaging for wearable medical devices, and ensuring prototypes meet performance and regulatory requirements.
As part of Xsensio, you will work in a fast-paced, multidisciplinary environment where your work directly shapes next-generation medical technologies.
Responsibilities
System integration & design: Lead the integration of mechanical and electronic components, ensuring the seamless functionality of Xsensio’s medical devices.
* Prototyping: Design and build prototypes of innovative medical devices using advanced 3D design tools and rapid prototyping techniques to iterate and refine concepts.
* Mechanical packaging: Design robust, ergonomic, and manufacturable device enclosures and packaging for wearable medical devices.
* Testing & verification: Develop and execute testing protocols to evaluate device performance (e.g. mechanical, thermal, and environmental testing) and ensure compliance with applicable medical device standards.
* Cross-functional collaboration: Work closely with electrical engineers, biomedical scientists, and other stakeholders.
* Design transfer to manufacturing: Prepare design documentation for manufacturing, including drawings, specifications, and bills of materials, and work with external manufacturers during transfer.
* Regulatory compliance: Ensure compliance with relevant medical device regulations (e.g., ISO 13485, FDA 21 CFR Part 820) during the design and development process.
Qualifications
* Education: Master’s or Ph.D. in Mechanical Engineering, Microengineering, Biomedical Engineering, Materials Science, or a related field.
* Experience: 3-5 years of experience in medical device development a must, particularly in wearable technologies.
* Prototyping expertise: strong skills in prototyping and 3D design using tools such as SolidWorks, AutoCAD, or similar.
* Testing knowledge: extensive experience conducting mechanical testing (e.g., durability, stress, fatigue, and environmental testing) with relevant equipment and methodologies.
* Integration skills: deep understanding of electromechanical systems and best practices for integrating mechanical, electronic, and software components.
* Manufacturing familiarity: experience in design transfer to manufacturing, including working with contract manufacturers a plus.
* Regulatory understanding: knowledge of medical device standards and regulations (e.g. ISO 13485, CE marking, FDA Class II or III devices) a plus.
Why Join Us?
* Be part of a pioneering team at the forefront of wearable healthcare innovation.
* Collaborate with a diverse, multidisciplinary team of experts passionate about improving patient care.
* Work on challenging, impactful projects in a fast-growing field.
* Opportunity for professional growth in an agile, innovation-driven company.
Seniority level
* Seniority level
Mid-Senior level
Employment type
* Employment type
Full-time
Job function
* Job function
Quality Assurance
* Industries
Medical and Diagnostic Laboratories
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