Systems Engineer

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., 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.

• 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.

Physical Demands:

The physical demands listed here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

• Required to sit; climb or balance; and stoop, kneel, crouch or crawl
• Required to regularly lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds
• Required to possess specific visons abilities, including: close vision, distance vision, color vision, peripheral vision, depth perception and capacity to adjust focus

Our Values:

Our Life Moves Us philosophy is built on four values: Passionate About Innovation, Customer Focused, Teamwork, and Driven.

• Passionate about Innovation: Improving patient care by delivering advanced technology to our customers is at the core of what we do. We are passionate in our role in improving the lives of patients by continuously developing better solutions.
• Customer Focused: We listen to our customers’ needs and respond with a sense of urgency.
• Teamwork: Working together, anything is possible. We value every person on our team and treat each other with respect. We are accountable to one another and support each other. Together, we make each other stronger.
• Driven: We pursue our mission with energy and passion. We are nimble, results-oriented and decisive. We overcome obstacles that arise in our quest to deliver solutions that will improve the lives of our customers and patients.