Senior Systems Engineer

Requirements

• Bachelor's degree in Software Engineering, Computer Engineering, Computer Science, Biomedical Engineering, Electrical Engineering, Systems Engineering, or equivalent degree/major required. Years of experience may be substituted for the degree requirement.
• Bachelor's degree with 8 years, Master's degree with 6 years, or PhD with 3 years of related experience with development or verification in the medical device industry (Class III medical device experience preferred).
• Mostly self-directed. Determines and pursues courses of action necessary to obtain desired results. (Recommendation

Benefits

Additional Information

At Globus Medical, we move with a sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. Our team is inspired by the needs of these patients, and the surgeons and healthcare providers who treat them. We embrace a culture of exceptional response by partnering with researchers and educators to transform clinical insights into tangible solutions. Our solutions improve the techniques and outcomes of surgery so patients can resume their lives as quickly as possible. Position Summary: The Senior Systems Engineer will design, develop, and deliver high-reliability mechanical components and assemblies for Class III implantable neuromodulation systems and associated external accessories used in spinal cord injury repair. This role ensures mechanical integrity, patient safety, and compliance with medical device regulations across the full product lifecycle. This engineer will also serve as a technical influencer, shaping mechanical architecture decisions, directing cross-functional design activities, and guiding teams toward robust, scalable engineering solutions. Essential Functions: The Senior Systems Engineer will play a key role in the development of a Class III implantable Neuromodulation systems used in spinal cord injury repair, working cross functionally to help define systems and ensure that all stakeholders are aligned, and user needs are met. In this role, you will be leading the technical team to make key and impactful decisions. Technical lead for system architecture and design of an implantable SCS system with wireless Bluetooth interfaces. Works with stakeholders, customers, and engineers to ensure the logical and systematic conversion of customer requirements and performance requirements into systems solutions that account for technical, cost and schedule constraints. Investigates and defines systems engineering requirements for new algorithms or features, and facilitates the transition of algorithms into new projects through clinical review and evaluation. Once requirements are defined with customers, speaks on their behalf to guide day-to-day engineering activities. Owns large efforts such as definition, verification or product development of a system, and drives them to on-time, high quality completion. Perform human factors engineering across the product lifecycle including identification of customer user needs and use scenario, definition of use specifications (user profiles, user environments) and user interface requirements. Generates deliverables for compliance with IEC 62366, ANSI/AAMI HE75, and FDA Guidance for Human Factors and Usability Engineering, including working with external vendors as necessary. Generates the cybersecurity deliverables for compliance with MDCG 2019-16, FDA Guidance Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions, and FDA Guidance Postmarket Management of Cybersecurity in Medical Devices. Leads and performs hands-on system integration testing and troubleshooting of technical issues. Works with development team to identify root cause and viable resolutions for issues. Leads system level verification against requirements. Creates test plans, procedures and reports, performs and analyzes system set up, and conducts verification and validation activities. Provide technical guidance to teams of engineers for systems engineering activities and deliverables Coordinates daily activities effectively across the systems engineering team during the design, implementation, and test phases. Provides status updates to the PMO on behalf of the systems engineering team. Adheres to the letter and spirit of the company Code of Conduct, the AdvaMed Code, MedTech Code, and all other company policies Ensures Compliance with applicable governmental laws, rules, and regulations, both in the United States and internationally, by completing introductory and annual training and maintaining knowledge of compliance as it applies to your role Represents the company in a professional manner and upholds the highest standards of ethical business practices and socially responsible conduct in all interactions with other employees, customers, suppliers, and other third parties Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.

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