Senior Systems Engineer

The Senior Systems Engineer will assume a pivotal role in the conceptualization, development, testing, and documentation of intra-aortic balloon pump consoles at our company. This individual will collaborate with a diverse team of engineers and have the opportunity to make meaningful contributions to a life-saving product. They will take the lead in systems engineering-related activities for product development initiatives and demonstrate exceptional verbal and written communication skills.

• Spearhead systems engineering initiatives for a sophisticated, software-driven medical device.
• Lead the creation and upkeep of product specifications, requirement documents, hazard analysis documents, and other technical records.
• Offer technical leadership throughout the phases of product design, development, integration, testing, and enhancements to reliability.
• Collaborate with subsystem teams, domain experts, and suppliers to identify, record, evaluate, and rectify defects.
• Work closely with a diverse technical team to generate, revise, and maintain documentation that becomes part of the product design history file (DHF).
• Execute projects with well-defined objectives and on-time deliverables, comprehending the objectives and contents of development and research projects.
• Serve as the technical liaison within the company, providing insights and recommendations for system verification aspects of projects.
• Maintain open and effective communication with the project manager and team members regarding project scope, timelines, and design alterations.

• Bachelor's degree in Systems Engineering, Biomedical Engineering, Electrical Engineering, Computer Science, or Mechanical Engineering (or equivalent in a technical/scientific field); a Master's degree is preferred.
• Over 7 years of experience as a Systems Engineer in product design, development, and/or testing, with a preference for experience in class II medical device products.
• Profound understanding of medical device product design and regulatory processes.
• Proficient in verbal and written communication.
• Familiarity with medical device design and development processes compliant with standards such as ISO 9000, ISO 13485, IEC 62304, IEC 60601, and ISO 14971.
• Strong grasp of system design, electronics, mechanical and software integration.
• Knowledge of design of experiments.
• Technical expertise in best-practice product development methodologies.

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