System Engineer Director

Alma Lasers, a global medical device company specializing in aesthetics and wellness, is in search of a seasoned Director of System Engineering to spearhead technological advancements within our organization.

Description:

• 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.

Requirement:

• 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.