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System Engineer Director - Chicago, United States - Alma Lasers
Description
Investigate and comprehend various requirements stemming from users, products, and marketing teams, and translate them into practical system and subsystem-level requirements.
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.
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