System Architect
3 weken geleden
Gilbert is embarking on a new phase of growth and is seeking an experienced System Architect to lead the design and development of its Soft Mist Inhaler System. This is a unique opportunity to be part of the foundation of a company and contribute to the creation of a revolutionary medical device.
Job SummaryThe System Architect will be responsible for designing and architecting the overall system, integrating both hardware and firmware components. This role requires a deep understanding of system architecture principles and the ability to collaborate with cross-functional teams using the latest technologies and industry practices.
Key Responsibilities- Own the system architecture design and implementation within the R&D team from design initiation through commercial launch
- Develop a comprehensive system architecture, ensuring complete and correct integration of the hardware with the firmware & software of the device
- Work with the (external) functional design team (EE/ME/FW/SW) to guide the detailed design implementation
- Define and document System and Product Requirements taking into account completeness, applicable standards and regulations
- Provide input to the system validation and verification team on test case/methodology development
- Apply advanced engineering and scientific principles to implement a system design that reduces design risk and optimizes design features, removing performance bottlenecks
- Create and maintain detailed technical documentation, including but not limited to system architecture diagrams, specifications and design documents to facilitate the CE certification process
- Minimum Bachelor's degree in biomedical, electrical, computer engineering or related field. 10+ years of relevant work experience. Advanced degree preferred.
- Experience in the design and delivery of complex embedded systems including software design, communication protocol design, and control systems
- Proficiency in hardware design tools (e.g., SolidWorks, Altium, Cadence) and firmware/software development languages (e.g., C, C++)
- Demonstrated project management experience, i.e. planning project deliveries, milestones and leading sub-teams in the delivery of their tasks
- Experience developing products in a regulated environment. Medical device industry experience, especially with respiratory drug delivery systems (e.g. ISO 13485, IEC 60601-1, MDR) is a plus
- Performs tasks independently while effectively collaborating with other team members
- Collaborative, team oriented and pragmatic approach
Ability to be creative, strategic, analytical, and think outside the box to solve problems; - Excellent attention to detail, commitment to excellence, and outstanding work ethic;
- Strong written, verbal, and communication skills
Besides a very entrepreneurial working environment, the candidate will be offered an attractive remuneration package next to opportunities for professional and personal development. The position will be full-time with associated benefits.
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