Senior Systems Engineer

Position Summary

The Senior Systems Engineer will design, develop, and deliver high-reliability Class III implantable neuromodulation systems and associated external accessories used in spinal cord injury repair. This role ensures system integrity, patient safety, and compliance with medical device regulations across the full product lifecycle. This engineer will also serve as a technical influencer, shaping system architecture decisions, directing cross-functional design activities, and guiding teams toward robust, scalable engineering solutions.

Essential Functions

• 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.

• Lead 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.

• Speaks on behalf of customers to guide day-to-day engineering activities.

• Owes large efforts such as definition, verification or product development of a system, and drives them to on-time, high quality completion.

• 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.

• Provides 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.

Qualifications

• 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 of assignments is often self-initiated.)
• Experience with development in a regulated industry such as medical device, defense, or automotive.
• Experience in Systems Engineering as related to stakeholder needs definition, creation of use case workflows, requirements definition and decomposition, functional architecture, and system design.
• Experience generating technical documentation such as product requirements, specifications, engineering reports, test plans & procedures, validation plans and reports.
• Experience working on multiple projects in a deadline driven environment.
• Experience with RF communications systems is desirable.
• Ability to generate buy-in from stakeholders to solutions for both technical and non-technical issues.
• Ability and willingness to make sound decisions potentially with high impact in a timely manner.
• Outstanding communication and presentation skills (written and verbal) to all levels of an organization.
• Experience interfacing with Software Development, Mechanical, Electrical, Operations, Quality and Regulatory.
• Usability engineering (human factors) experience with strongly desired.
• Risk management experience strongly desired.
• Cybersecurity in medical devices experience strongly desired.
• Project management skills including planning and estimation of tasks, milestones, resources, and budget desired.
• Willing to travel up to 10% as needed.