SR
Cybersecurity/Test Engineer / Regulatory Affairs Specialist
Accepting applicationsSurgerii Robotics · United States
Full-Time Associate MATLABPython
Posted
2d ago
Category
Verification
Experience
Associate
Country
United States
****Please note that we could not offer visa sponsorship****
About the Company
Surgerii Robotics develops and commercializes single-port laparoscopic surgical robotic systems, advancing minimally invasive surgery through innovative technology. The company has successfully established and rapidly expanded its presence in China and Europe and is now accelerating its development in the United States.
By joining our U.S. team, you will contribute directly to a critical stage of our expansion, from product localization and verification to U.S. regulatory clearance. We offer a competitive total rewards package. The scope of responsibilities and the career growth and advancement path will be shaped in discussion with each candidate, taking into account their experience, strengths, professional interests and preferences, and the evolving needs of the business.
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Product Cybersecurity Engineer — Surgical Robotics
Key Responsibilities
Analyze system architecture, data flows, trust boundaries, and attack surfaces; develop and maintain threat models and cybersecurity risk assessments, including security-related safety impacts.
Translate risks into traceable security requirements and controls, working with engineering teams on areas such as authentication, secure communications, system hardening, logging, software updates, and recovery.
Perform or coordinate product security assessments and testing appropriate to the system, including software composition, vulnerability, network or protocol, and penetration testing; drive findings through remediation, retesting, and closure.
Maintain the Software Bill of Materials (SBOM), third-party component inventory, known-vulnerability assessments, and related configuration records.
Author controlled cybersecurity plans, risk files, test protocols and reports, change-impact assessments, and evidence for FDA Q-Submissions and applicable premarket submissions, including Section 524B documentation where relevant.
Support post-market vulnerability monitoring, coordinated disclosure, patch planning, and product-security incident investigation while collaborating with R&D, Quality, Regulatory, Test, and Service teams in China and the United States.
Required Qualifications
Bachelor’s degree or higher in Cybersecurity, Computer Science, Computer Engineering, Electrical Engineering, Software Engineering, Systems Engineering, or a related technical field.
2-8 years of product cybersecurity or security-engineering experience involving an embedded, connected, regulated, or safety-critical product.
Hands-on experience with threat modeling or cybersecurity risk assessment, together with practical security implementation, vulnerability analysis, or product security testing.
Solid understanding of embedded or connected-system security, with the ability to turn product architecture and risks into practical, testable controls.
Experience authoring formal technical or controlled documentation, maintaining traceability, and communicating clearly in English across technical and cross-functional teams.
Preferred Qualifications
Experience with surgical robotics, complex medical devices, medical equipment, or other cyber-physical products.
Experience supporting FDA premarket or post-market cybersecurity activities; familiarity with FDA cybersecurity guidance, Section 524B, ISO 14971, IEC 62304, or IEC 81001-5-1.
Experience securing Linux, Windows, embedded, or networked products and using scripting or security tools for testing, analysis, or automation.
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Systems Test and Verification Engineer — Surgical Robotics
Location: North Haven, Connecticut&Greater Boston On-site
Role Purpose:
Perform system-level testing and design verification for Surgerii’s single-port laparoscopic surgical robotic system, including related instruments, accessories, software, and supporting equipment. This is a hands-on role requiring the engineer to personally author controlled test documentation, configure test environments, operate the system, investigate failures, and produce traceable evidence for design reviews and U.S. regulatory submissions. The final scope will reflect the selected candidate’s experience.
Responsibilities
Translate system requirements and risk-control measures into test plans, coverage, and acceptance criteria, maintaining traceability across requirements, risks, and tests.
Personally develop system- and subsystem-level test methods, protocols, test cases, and reports.
Set up test fixtures, instruments, benchtop systems, and simulated-use environments, and directly operate the product to execute testing.
Analyze test data, failures, and deviations; support root-cause investigations; and perform retesting to verify corrective actions.
Assess the impact of hardware, software, and system changes on test scope and existing verification evidence.
Collaborate with R&D, Quality, Regulatory, Clinical, and Manufacturing teams in China and the United States to deliver complete, accurate, and audit-ready verification documentation on schedule.
Qualifications
Bachelor’s degree or higher in Mechanical Engineering, Electrical Engineering, Mechatronics, Biomedical Engineering, Systems Engineering, Robotics, or a related engineering discipline.
2-8 years of experience in systems testing, design verification, or regulated product development.
Recent hands-on experience testing complex hardware or electromechanical systems and personally authoring the related controlled protocols and reports.
Ability to interpret product requirements, maintain traceability among requirements, risks, tests, and defects, and investigate failures and evaluate results.
Working knowledge of medical-device design controls, risk management, and quality-system documentation.
Strong English technical-writing skills and the ability to collaborate effectively across international teams.
Required Skills
Experience with surgical robotics, capital medical equipment, endoscopy, medical imaging, surgical navigation, or other complex medical devices.
Familiarity with FDA Quality Management System Regulation (QMSR), ISO 13485, ISO 14971, IEC 60601, IEC 62304, or applicable human-factors requirements.
Experience developing test fixtures or instrumentation, validating test methods, conducting reliability testing, or using Python, MATLAB, or LabVIEW for test automation and data analysis.
Preferred Skills
Experience with surgical robotics, capital medical equipment, endoscopy, medical imaging, surgical navigation, or other complex medical devices.
Familiarity with FDA Quality Management System Regulation (QMSR), ISO 13485, ISO 14971, IEC 60601, IEC 62304, or applicable human-factors requirements.
Experience developing test fixtures or instrumentation, validating test methods, conducting reliability testing, or using Python, MATLAB, or LabVIEW for test automation and data analysis.
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Regulatory Affairs Specialist — Surgical Robotics, U.S. Market
Location: North Haven, Connecticut&Greater Boston On-site
Role Purpose:
Support U.S. market entry for Surgerii’s single-port laparoscopic surgical robotic system and related instruments, accessories, and software. This is a hands-on role requiring the specialist to personally draft submission content, review technical evidence, identify regulation/documentation gaps, and prepare materials for FDA interactions. The final scope will reflect the selected candidate’s experience and the confirmed U.S. regulatory pathway.
Responsibilities
Assess product classification, intended use, claims, and applicable regulatory requirements to support the U.S. regulatory pathway and submission plan.
Personally author and compile Q-Submission materials and applicable U.S. premarket submissions, such as a 510(k) or De Novo request.
Review the regulatory adequacy of technical evidence, including product requirements, risk management, systems testing and design verification, software and cybersecurity, human factors, and labeling.
Identify evidence, regulation and documentation gaps, define the additional information required, and work with technical owners to track each gap to closure.
Draft FDA meeting materials, correspondence, and responses to requests for additional information, and support direct interactions with the agency.
Assess the regulatory impact of product changes, maintain submission records and timelines, and coordinate deliverables across teams in China and the United States.
Qualifications
Bachelor’s degree or higher in Engineering, Biomedical Science, Regulatory Affairs, or a related discipline.
2-8 years of medical-device regulatory experience, including direct involvement in a U.S. premarket submission.
Recent experience personally authoring or substantively revising submission sections and reviewing testing, risk-management, or other product-development evidence.
Ability to understand complex technical information and convert it into clear, consistent, submission-ready English regulatory documentation.
Working knowledge of U.S. medical-device premarket submissions, FDA QMSR, ISO 13485, and regulated product-development processes.
Strong analytical, document-management, and cross-border collaboration skills.
Preferred Qualifications
Direct involvement in a Q-Submission, 510(k), De Novo request, or another applicable U.S. submission for a new product or significant change; experience with the electronic Submission Template and Resource (eSTAR) or responses to FDA requests for additional information is preferred.
Experience with surgical robotics, capital medical equipment, medical-device software, or other complex Class IIb medical devices.
Familiarity with ISO 14971, IEC 60601, IEC 62304, and applicable cybersecurity, human-factors, steril
Show more Show less
About the Company
Surgerii Robotics develops and commercializes single-port laparoscopic surgical robotic systems, advancing minimally invasive surgery through innovative technology. The company has successfully established and rapidly expanded its presence in China and Europe and is now accelerating its development in the United States.
By joining our U.S. team, you will contribute directly to a critical stage of our expansion, from product localization and verification to U.S. regulatory clearance. We offer a competitive total rewards package. The scope of responsibilities and the career growth and advancement path will be shaped in discussion with each candidate, taking into account their experience, strengths, professional interests and preferences, and the evolving needs of the business.
----------------------------------------------------------------------------------------------------
Product Cybersecurity Engineer — Surgical Robotics
Key Responsibilities
Analyze system architecture, data flows, trust boundaries, and attack surfaces; develop and maintain threat models and cybersecurity risk assessments, including security-related safety impacts.
Translate risks into traceable security requirements and controls, working with engineering teams on areas such as authentication, secure communications, system hardening, logging, software updates, and recovery.
Perform or coordinate product security assessments and testing appropriate to the system, including software composition, vulnerability, network or protocol, and penetration testing; drive findings through remediation, retesting, and closure.
Maintain the Software Bill of Materials (SBOM), third-party component inventory, known-vulnerability assessments, and related configuration records.
Author controlled cybersecurity plans, risk files, test protocols and reports, change-impact assessments, and evidence for FDA Q-Submissions and applicable premarket submissions, including Section 524B documentation where relevant.
Support post-market vulnerability monitoring, coordinated disclosure, patch planning, and product-security incident investigation while collaborating with R&D, Quality, Regulatory, Test, and Service teams in China and the United States.
Required Qualifications
Bachelor’s degree or higher in Cybersecurity, Computer Science, Computer Engineering, Electrical Engineering, Software Engineering, Systems Engineering, or a related technical field.
2-8 years of product cybersecurity or security-engineering experience involving an embedded, connected, regulated, or safety-critical product.
Hands-on experience with threat modeling or cybersecurity risk assessment, together with practical security implementation, vulnerability analysis, or product security testing.
Solid understanding of embedded or connected-system security, with the ability to turn product architecture and risks into practical, testable controls.
Experience authoring formal technical or controlled documentation, maintaining traceability, and communicating clearly in English across technical and cross-functional teams.
Preferred Qualifications
Experience with surgical robotics, complex medical devices, medical equipment, or other cyber-physical products.
Experience supporting FDA premarket or post-market cybersecurity activities; familiarity with FDA cybersecurity guidance, Section 524B, ISO 14971, IEC 62304, or IEC 81001-5-1.
Experience securing Linux, Windows, embedded, or networked products and using scripting or security tools for testing, analysis, or automation.
----------------------------------------------------------------------------------------------------
Systems Test and Verification Engineer — Surgical Robotics
Location: North Haven, Connecticut&Greater Boston On-site
Role Purpose:
Perform system-level testing and design verification for Surgerii’s single-port laparoscopic surgical robotic system, including related instruments, accessories, software, and supporting equipment. This is a hands-on role requiring the engineer to personally author controlled test documentation, configure test environments, operate the system, investigate failures, and produce traceable evidence for design reviews and U.S. regulatory submissions. The final scope will reflect the selected candidate’s experience.
Responsibilities
Translate system requirements and risk-control measures into test plans, coverage, and acceptance criteria, maintaining traceability across requirements, risks, and tests.
Personally develop system- and subsystem-level test methods, protocols, test cases, and reports.
Set up test fixtures, instruments, benchtop systems, and simulated-use environments, and directly operate the product to execute testing.
Analyze test data, failures, and deviations; support root-cause investigations; and perform retesting to verify corrective actions.
Assess the impact of hardware, software, and system changes on test scope and existing verification evidence.
Collaborate with R&D, Quality, Regulatory, Clinical, and Manufacturing teams in China and the United States to deliver complete, accurate, and audit-ready verification documentation on schedule.
Qualifications
Bachelor’s degree or higher in Mechanical Engineering, Electrical Engineering, Mechatronics, Biomedical Engineering, Systems Engineering, Robotics, or a related engineering discipline.
2-8 years of experience in systems testing, design verification, or regulated product development.
Recent hands-on experience testing complex hardware or electromechanical systems and personally authoring the related controlled protocols and reports.
Ability to interpret product requirements, maintain traceability among requirements, risks, tests, and defects, and investigate failures and evaluate results.
Working knowledge of medical-device design controls, risk management, and quality-system documentation.
Strong English technical-writing skills and the ability to collaborate effectively across international teams.
Required Skills
Experience with surgical robotics, capital medical equipment, endoscopy, medical imaging, surgical navigation, or other complex medical devices.
Familiarity with FDA Quality Management System Regulation (QMSR), ISO 13485, ISO 14971, IEC 60601, IEC 62304, or applicable human-factors requirements.
Experience developing test fixtures or instrumentation, validating test methods, conducting reliability testing, or using Python, MATLAB, or LabVIEW for test automation and data analysis.
Preferred Skills
Experience with surgical robotics, capital medical equipment, endoscopy, medical imaging, surgical navigation, or other complex medical devices.
Familiarity with FDA Quality Management System Regulation (QMSR), ISO 13485, ISO 14971, IEC 60601, IEC 62304, or applicable human-factors requirements.
Experience developing test fixtures or instrumentation, validating test methods, conducting reliability testing, or using Python, MATLAB, or LabVIEW for test automation and data analysis.
----------------------------------------------------------------------------------------------------
Regulatory Affairs Specialist — Surgical Robotics, U.S. Market
Location: North Haven, Connecticut&Greater Boston On-site
Role Purpose:
Support U.S. market entry for Surgerii’s single-port laparoscopic surgical robotic system and related instruments, accessories, and software. This is a hands-on role requiring the specialist to personally draft submission content, review technical evidence, identify regulation/documentation gaps, and prepare materials for FDA interactions. The final scope will reflect the selected candidate’s experience and the confirmed U.S. regulatory pathway.
Responsibilities
Assess product classification, intended use, claims, and applicable regulatory requirements to support the U.S. regulatory pathway and submission plan.
Personally author and compile Q-Submission materials and applicable U.S. premarket submissions, such as a 510(k) or De Novo request.
Review the regulatory adequacy of technical evidence, including product requirements, risk management, systems testing and design verification, software and cybersecurity, human factors, and labeling.
Identify evidence, regulation and documentation gaps, define the additional information required, and work with technical owners to track each gap to closure.
Draft FDA meeting materials, correspondence, and responses to requests for additional information, and support direct interactions with the agency.
Assess the regulatory impact of product changes, maintain submission records and timelines, and coordinate deliverables across teams in China and the United States.
Qualifications
Bachelor’s degree or higher in Engineering, Biomedical Science, Regulatory Affairs, or a related discipline.
2-8 years of medical-device regulatory experience, including direct involvement in a U.S. premarket submission.
Recent experience personally authoring or substantively revising submission sections and reviewing testing, risk-management, or other product-development evidence.
Ability to understand complex technical information and convert it into clear, consistent, submission-ready English regulatory documentation.
Working knowledge of U.S. medical-device premarket submissions, FDA QMSR, ISO 13485, and regulated product-development processes.
Strong analytical, document-management, and cross-border collaboration skills.
Preferred Qualifications
Direct involvement in a Q-Submission, 510(k), De Novo request, or another applicable U.S. submission for a new product or significant change; experience with the electronic Submission Template and Resource (eSTAR) or responses to FDA requests for additional information is preferred.
Experience with surgical robotics, capital medical equipment, medical-device software, or other complex Class IIb medical devices.
Familiarity with ISO 14971, IEC 60601, IEC 62304, and applicable cybersecurity, human-factors, steril
Show more Show less