Staff Systems Engineer

At Apricity Robotics we strive to harness the power of AI and robotics to bring the warmth of hope and healing, revolutionizing healthcare and transforming challenging situations into opportunities for growth and progress. Our robot is improving sonographers’ quality of life and improving the quality of ultrasound scans. Our team is differentiated by its expertise in creativity, engineering, and delivering robots with advanced intelligence, dexterity, and care – specifically designed to work alongside people, in existing environments. Every day, we embrace challenging problems, developing new solutions and practical implementations that make robots intuitive and exceptional co‑workers. We approach our work with passion, making every day an adventure. About The Role We are looking for a seasoned systems engineer to own systems engineering and design assurance for our robotic platform, and to guide our team in building a de‑risked product. This role is located in person in Dublin, Ohio. You will own the system architecture, the requirements that flow through it, the interfaces between subsystems, the risk management file, the verification and validation program, the traceability matrix, and the Design History File. More than owning those artifacts, you will set how we build: bringing risk‑based thinking into design decisions from the start so that safety, verifiability, and standards conformance are engineered in rather than discovered late. This is a hands‑on, technically credible role. You will be deep in the design with the engineering team, not waiting at the end to inspect their work, and you will be the person who guides our development to design hazards out and to build to the standards that govern our device. You will report to the VP of Engineering, work shoulder to shoulder with our mechanical, electrical, software, controls, and clinical teams, and partner with our regulatory strategy on the path to 510(k). As the company grows, this role anchors the systems engineering discipline. What You’ll Do Establish and run the risk‑based design process the engineering team works within, driving identified hazards to documented mitigation before each design freeze so issues surface in design review rather than in V&V or audit. Translate user and clinical needs into verifiable engineering specifications with defined acceptance criteria, including power budgets, performance targets, weight and dimensional limits, and applied‑force and safety limits that hardware and software build to. Own the system architecture and author the interface control documents that define every data, power, and mechanical interface across the robotic arm, electronics, firmware, software, and ultrasound system, so integration failures are prevented by design rather than found at bring‑up. Build and maintain the traceability matrix linking every user need to a system requirement, design output, and test case, with no orphan requirements and complete verification coverage at submission. Lead risk management under ISO 14971: run hazard analysis and FMEAs, and trace every identified hazard to a verified mitigation, with residual risk reduced to within defined acceptance criteria. Own the verification and validation program: author and approve protocols and reports, drive execution against the V&V plan, and verify every design output against its design input with documented, traceable results. Own the Design History File and the design control process, hold design reviews at each phase gate with recorded action closure, and bring the design controls work currently held by outside consultants fully in‑house. Establish and verify conformance to the applicable standards (the IEC 60601 family, IEC 62304 for software, IEC 62366 for usability, and ISO 14971 for risk), maintaining a documented conformance assessment for each and closing gaps before design freeze. Lead system integration and bring‑up, root‑causing cross‑domain failures and driving the integrated system to meet its system‑level performance specifications. Stand up the configuration management, design review, and requirements and test‑management tooling the program runs on, and track design controls progress against the development schedule. Partner with regulatory strategy on the 510(k), delivering a complete, submission‑ready design controls and V&V evidence package on the timeline the filing requires. About You Degree in Systems Engineering, Electrical Engineering, Mechanical Engineering, Robotics, or a related technical discipline, with an advanced degree a plus. 8+ years in systems engineering or design assurance for FDA‑regulated medical devices (Class II or higher), including products you have taken through verification and validation and into or through a 510(k) or comparable submission. Genuinely dual‑strength, which is the heart of this role: enough engineering depth to guide architecture and interface decisions and earn the respect of your engineers, paired with deep command of design controls (21 CFR 820.30, now under FDA’s QMSR), traceability, risk management (ISO 14971), and V&V. Hands‑on across hardware, software, and controls, fluent enough to integrate them, arbitrate between them, and debug across domain boundaries in the lab. Fluency in the applicable consensus standards and how to apply them in practice, not just cite them: IEC 60601, IEC 62304, IEC 62366, ISO 13485, and ISO 14971. Define and drive the verification and validation strategy: test planning, requirement verification, and system‑level integration testing that produces the evidence our submission depends on. Strong technical writing: you can author a specification, a protocol, a report, or a traceability matrix that is clear, complete, and audit ready. Comfort operating without a defined playbook. You will be standing up this discipline at Apricity, not inheriting a mature system. High energy, intrinsic motivation, and the focus to drive intensely on the problems that matter most. Bonus Points Robotics, motion control, or real‑time controls experience. Experience in cardiac imaging, ultrasound, or other imaging devices. Experience integrating with or qualifying third‑party OEM hardware, ideally medical imaging systems. Familiarity with premarket cybersecurity expectations for connected medical devices. Experience with requirements, ALM, or eQMS tooling (e.g., Jama, Polarion, Greenlight Guru, DOORS) and with model‑based systems engineering (SysML). Quality or regulatory certification such as ASQ CQE or CQA, or RAC. Prior early‑stage or startup medtech experience. Compensation Salary: $143,000–$203,000 annually, depending on experience. Competitive stock options. 401(k) with employer match. Employee medical, dental, and vision insurance 100% covered by Apricity, with options to add dependents through a subsidized pre‑tax deduction. Insurance Coverage: medical, dental, and vision insurance available. Flexible Time Off policy. 10 paid company holidays, including an end of year holiday shut down. Relocation assistance available to move you near our Dublin, Ohio office. Applicants must be authorized to work for any employer in the U.S. Apricity Robotics is committed to a work environment in which all individuals are treated with respect and dignity. Each individual has the right to work in a professional atmosphere that promotes equal employment opportunities and prohibits unlawful discriminatory practices, including harassment. Therefore, it is the policy of Apricity Robotics to ensure equal employment opportunity without discrimination or harassment on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, age, disability, marital status, citizenship, national origin, genetic information, or any other characteristic protected by law. Apricity Robotics prohibits any such discrimination or harassment. #J-18808-Ljbffr Apricityrobotics