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About The Position
- Investigate and comprehend various requirements stemming from users, products, and marketing teams, and translate them into practical system and subsystem-level requirements.
- Manage system requirements, system specifications, and system working parameters.
- Partition the large system into subsystems, modules, and components, each clearly defined and straightforward to implement.
- Participate in risk management activities and documentation.
- Define, plan, and lead system design and integration using a cross-disciplinary team of engineers.
- Drive verification and validation activities for the overall product, including subsystem and system-level testing.
- Collaborate with the regulatory team to provide and maintain regulatory design inputs and ensure systems compliance.
- Work with project and program managers to create and manage project schedules.
Requirements
- BSc. in Systems, Electrical, Electro-optical, Mechanical, Bio-medical, or Computer Engineering from a leading university. A Master's degree is an advantage.
- 5+ years of experience in the development of multi-disciplinary medical devices – Mandatory.
- 5+ years of experience in a system engineering role.
- Experience with technologically complex multidisciplinary systems, including hardware and software experience at multi-disciplinary medical device companies.
- Knowledge and understanding of Medical Device Compliance and Medical standards (e.g., 60601, 62304, 14971, 13485, etc.).
- Interpersonal skills and excellent teamwork: The ability to address technical and human challenges.
- Experience with Medical Regulatory submissions.
- Knowledge of testing methodologies.
- Strong documentation skills and effective communication at all levels of the organization.
- Self-management and technical leadership ability.
- Team Leadership: Ability to lead and manage a technical team effectively.
Let’s talk about your future