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With microscopic resolutions leading to Gigabytes of pixel data per glass slide,party AI integration etc., while bringing in platform and workflow harmonization. Looking for a bright mind who feels excited to drive systems engineering across our solution offerings.
Your role:
Leads system design and development with software, hardware & IT engineers and project teams
Develops and designs medical software systems as part of the defined product/technology roadmap. Is able to document and present system design to development managers, project leaders and development teams
Technically responsible (together with the project leader) for designing and implementing the required functionality
Assists the project leader in a work breakdown and drafting realistic schedules
Determines the required product requirements and interoperability with the architecture team and subject matter experts
Analyzes User requirements, regulations and standards (e.g. FDA, NIST, ISO, IEC) and translates these into product requirements and performs FMEA
Is an auditee in audits (internal and external e.g. Dekra) on Design and Development including Design Controls
Owner of the System Requirements and System Designs for multiple projects/products
Contributes to process improvements activities e.g. deployment of Design & Development processes, Risk Management and lean creation of the Design History File
.You're the right fit if:
Master's degree in Engineering or Computer Science
A minimum of 10 years of experience in medical device development as a Systems Designer
Deep understanding of software architecture and product interoperability, incl. hands-on experience, in system design, modular design and development
Deep understanding of medical device design and development e.g in deployment of Product Development processes, Risk Management and lean creation of the Design History File and working under a QMS
Experienced in dealing with system architecture in multi-disciplinary teams (Pathology Scanner, Medical, Clinical, Regulatory, Quality Assurance, Risk Management etc.)
A minimum of 5 years of experience as an auditee on Design Controls, Risk Management, and ISO 13485 Quality Systems, DHF, IEC62304
Excellent written and verbal communication in the English language and interpersonal skills to be an architecture lead in multi-disciplinary teams
We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.
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