Responsible to assure Quality and Compliance and provide overall Quality guidance during development and validation of apps, virtual servers (clouds), management of device-generated data, and cyber security.
- Reviews and approves design and development planning documents and design change requests.
- Reviews and approves product requirements, system requirements, apps requirements specifications, cloud infrastructure, platform and application.
- Reviews and approves Risk Management documentation.
- Review and approve Apps Test, cloud Validation Test protocols and reports.
- Reviews and approvals ensure document deliverables with internal directives and SOPs, and external industry standards and regulations.
- Influence the requirements definition to ensure the appropriate scope of the device is clear with its interface with the clouds using apps, and any non-medical electronic device is separated from the device accessories.
- Act as a process advisor to coordinate risk controls, specification traces, verification / validation testing, and anomalies tracking for resolution.
- Work closely with the apps and clouds development team in risk management.
- Collaborate with other engineering disciplines, to ensure the apps, the clouds and the interface with the medical device will accomplish design goals for a particular product.
- Help guide R&D teams through Quality Management System to ensure apps, clouds, interfaces and cyber security are developed in compliance to internal procedures, requirements from FDA, ISO, and other regulatory bodies.
The roles and responsibilities for this position are combined as a Design Quality Engineer with emphasis in modern Information Technologies.
Scope of the referenced key activities and responsibilities is primarily project-based, with extended scope for the development and/or update of procedures, work instructions, forms and templates required to execute this role.
- Bachelor Degree in Computer Science, Computer Engineering, or Software Engineering
- Thorough understanding of software quality assurance principles, practices and metrics, as well as best practices that foster high quality software, apps and clouds.
- Deep knowledge of the use of apps for medical devices and its interface with cloud platforms.
- Excellent analytical, problem solving, organizational, and communication skills.
3+ years in the field of cloud computing technology and services, with at least 1 years of hands on experience in a technical Quality role supporting a product design function in the development, testing, validation, approval and release of embedded software in medical devices and its interfaces with apps and data storage in virtual servers (clouds).
Demonstrated work experience in a role within a Design Quality function with responsibility of Quality Assurance and Compliance for device software in FDA regulated products.
Hands-On experience with network\storage devices\solutions.
Work experience with data management, apps, cyber security, cloud computing, and interfaces with medical device equipment.
Proven record supporting the development and execution of software test protocols for complex medical devices.
Familiarity with EN 62304, EN ISO 14971, EN 62366, and international standards applicable to medical device design, development, verification and validation.
Working knowledge of FDA guidance for Medical Device Software Validation
-Former experience as a software developer using C, C++, C#, APIs, or equivalent.
-Former experience supporting development and validation of private or public clouds.
-Worked with teams on 510(k) submissions and/or PMAS.
-Familiarity with the development of apps and clouds (SaaS, IaaS, PaaS).