About this role: 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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How to apply
If you meet the above requirements and would like to be considered for this role, please submit your interest using the ‘Apply’ button. Applying is quick and easy – just make sure you have the following documents ready to go:
- Cover Letter (optional)