job summary :
Responsible for the overall Systems Engineering deliverables and activities including translation of user and business requirements to product requirements, technical approach and system architecture development, harmonization of system design among the relevant products and projects of the segment(s), allocation of derived requirements to subsystems, and integration strategy and methods.
Drives refinement and translation of user requirements (including but not limited to clinical, serviceability, reliability, and manufacturability), regulatory requirements, and system architecture and concepts into functional requirements.
responsibilities :
- You've acquired a minimum of 5 years experience successfully developing complex medical devices and a focus in systems engineering (hardware, software, consumables), with experience in Sleep Therapy / Ventilation products and accessories highly desired.
- You have a strong understanding of System Design process, including Model-Based (MBSE / V-Model) Design approach-conceptualization, writing requirements, functional and technical design, check & optimize, verification, integration and finally validation.
- You have experience in test-Driven design methodologies, analytical and architectural thinking, system view, physical insight, flexibility, and a hands-on mentality to deliver sustainable results and creative solutions.
- You have effective communication, computer, documentation, presentation, and interpersonal skills, as well as the ability to work independently, cross-functionally, and collaboratively.
- You have strong knowledge of Medical Device / FDA Quality System Regulations (ISO 13485 / 14971 / 10993 / 18562 ,17510 2015, IEC 62366 etc.
and clearance processes.
qualifications :
- Experience level : Experienced
- Minimum 5 years of experience
- Education : Bachelors (required)
skills :
- Professional Engineer
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