{"schemaVersion":"jobsearcher.job.v1","id":"a4a4e8b3c156b67555e8a063","url":"https://jobsearcher.com/jobs/a4a4e8b3c156b67555e8a063","canonicalUrl":"https://jobsearcher.com/jobs/a4a4e8b3c156b67555e8a063","title":"Senior Systems Engineer","description":"Role: Senior Systems EngineerLocation: Cambridge, MA — in-person strongly preferredTo apply: Email jobs@lambdasurgical.com with your resume/LinkedIn and three bullets demonstrating evidence of exceptional ability.About Lambda SurgicalLambda Surgical is building physical intelligence for surgery. As more procedures move to camera-based approaches, surgeons increasingly operate from a 2D projection rather than a true spatial understanding of the operative field.Our first product, LambdaGuide, is a LiDAR-based spatial measurement system designed to integrate into existing endoscopic and robotic workflows and improve intraoperative precision. Pending FDA clearance, LambdaGuide has the potential to dramatically change how surgeons measure, navigate, and make decisions inside the body.Backed by some of the world's leading technology investors, Lambda is building toward a future in which surgery is more precise, more intelligent, and more autonomous. Ultimately, we believe LambdaGuide will become the foundation for autonomous surgery by enabling the same core capability that unlocked autonomy in robotics: an adaptive world model that learns from expert human operators.Role OverviewWe're looking for a Senior Systems Engineer to own the technical definition of our product from concept through FDA submission. You will translate clinical and product needs into engineering requirements, ensure those requirements are verified through rigorous testing, guide the team through structured design reviews, and maintain the technical documentation that demonstrates our device is safe, effective, and ready for regulatory submission.This role sits at the intersection of engineering, product development, quality, regulatory, and clinical. You will work across optics, electronics, firmware, software, algorithms, mechanical engineering, manufacturing, and clinical teams to ensure every design decision is captured, every requirement is traceable, every risk is mitigated, and every verification activity is properly planned and documented.This role is ideal for someone who enjoys bringing structure to complex multidisciplinary engineering efforts and wants to help build a novel medical device from early development through FDA clearance.ResponsibilitiesOwn the system requirements for LambdaGuide, translating customer, clinical, regulatory, and engineering inputs into clear, testable, and traceable requirements.Maintain end-to-end requirements traceability between user needs, system requirements, subsystem requirements, verification activities, and regulatory documentation.Lead system-level risk management activities, including hazard analysis, FMEAs, risk controls, residual risk evaluation, and risk traceability in accordance with ISO 14971.Develop verification strategies and author verification protocols, test procedures, acceptance criteria, and reports to demonstrate compliance with system requirements.Plan, organize, and facilitate phased design reviews throughout development, ensuring technical readiness, documentation completeness, and cross-functional alignment.Coordinate closely with engineering teams to ensure design decisions, tradeoffs, and verification evidence are properly documented throughout the product lifecycle.Work alongside Quality and Regulatory to prepare the engineering content of FDA submissions, including device descriptions, verification summaries, risk documentation, software documentation, performance testing, and supporting technical reports.Support engineering investigations, root cause analyses, design changes, and CAPA activities by assessing system-level impacts and maintaining documentation consistency.Help establish and continuously improve systems engineering processes, documentation standards, and development workflows as Lambda scales.Ideal BackgroundBachelor's or Master's degree in Biomedical Engineering, Mechanical Engineering, Electrical Engineering, Systems Engineering, or a related engineering discipline.Approximately 3–5 years of experience developing regulated medical devices in a systems engineering, product development, R&D, or design assurance role.Experience developing and managing engineering requirements, requirements traceability, verification plans, and design documentation throughout the medical device development lifecycle.Strong understanding of medical device design controls, Design History Files (DHF), and product development under FDA Quality System Regulation and/or ISO 13485.Experience performing risk management activities under ISO 14971, including hazard analyses, FMEAs, risk control verification, and residual risk assessment.Experience authoring verification protocols, executing engineering verification activities, and producing high-quality technical reports suitable for regulatory submissions.Demonstrated ability to lead multidisciplinary engineering efforts spanning mechanical, electrical, firmware, software, and systems integration.Strong technical writing skills with exceptional attention to detail and an ability to communicate complex engineering concepts clearly.Experience supporting 510(k), De Novo, PMA, or international regulatory submissions is strongly preferred.Experience with surgical imaging, robotics, medical imaging, capital equipment, or other complex medical devices is a plus.Traits We ValueUtmost integrity. We need people who are honest, rigorous, trustworthy, and guided by a strong moral backbone and a genuine desire to do good with their time on earth. We value people who surface the truth quickly, even when it is inconvenient or difficult.High agency. We need people who take ownership, figure things out, create structure where it is missing, and drive ambiguous problems to resolution.Clear communication. We need people who can communicate clearly, directly, and thoughtfully across functions, including engineering, clinical, quality/regulatory, operations, leadership, partners, and customers.Other traits we value: curiosity, first-principles thinking, practical judgment, attention to detail, comfort with ambiguity, low ego, urgency, and excitement to build foundational technology for the future of surgery","company":"Lambda Surgical","rawCompany":"lambda surgical","city":"Somerville","state":"MA","isRemote":false,"isActive":false,"createdAt":"2026-07-15T09:19:35.519Z","occupations":[{"code":"17-2199.00","title":"Engineers, All Other","slug":"engineers-all-other"},{"code":"17-2031.00","title":"Bioengineers and Biomedical Engineers","slug":"bioengineers-and-biomedical-engineers"},{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"}],"industries":[{"code":"339113","title":"Surgical Appliance and Supplies Manufacturing","slug":"surgical-appliance-and-supplies-manufacturing"},{"code":"339112","title":"Surgical and Medical Instrument Manufacturing","slug":"surgical-and-medical-instrument-manufacturing"},{"code":"334510","title":"Electromedical and Electrotherapeutic Apparatus Manufacturing","slug":"electromedical-and-electrotherapeutic-apparatus-manufacturing"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Senior Systems Engineer","description":"Role: Senior Systems EngineerLocation: Cambridge, MA — in-person strongly preferredTo apply: Email jobs@lambdasurgical.com with your resume/LinkedIn and three bullets demonstrating evidence of exceptional ability.About Lambda SurgicalLambda Surgical is building physical intelligence for surgery. As more procedures move to camera-based approaches, surgeons increasingly operate from a 2D projection rather than a true spatial understanding of the operative field.Our first product, LambdaGuide, is a LiDAR-based spatial measurement system designed to integrate into existing endoscopic and robotic workflows and improve intraoperative precision. Pending FDA clearance, LambdaGuide has the potential to dramatically change how surgeons measure, navigate, and make decisions inside the body.Backed by some of the world's leading technology investors, Lambda is building toward a future in which surgery is more precise, more intelligent, and more autonomous. Ultimately, we believe LambdaGuide will become the foundation for autonomous surgery by enabling the same core capability that unlocked autonomy in robotics: an adaptive world model that learns from expert human operators.Role OverviewWe're looking for a Senior Systems Engineer to own the technical definition of our product from concept through FDA submission. You will translate clinical and product needs into engineering requirements, ensure those requirements are verified through rigorous testing, guide the team through structured design reviews, and maintain the technical documentation that demonstrates our device is safe, effective, and ready for regulatory submission.This role sits at the intersection of engineering, product development, quality, regulatory, and clinical. You will work across optics, electronics, firmware, software, algorithms, mechanical engineering, manufacturing, and clinical teams to ensure every design decision is captured, every requirement is traceable, every risk is mitigated, and every verification activity is properly planned and documented.This role is ideal for someone who enjoys bringing structure to complex multidisciplinary engineering efforts and wants to help build a novel medical device from early development through FDA clearance.ResponsibilitiesOwn the system requirements for LambdaGuide, translating customer, clinical, regulatory, and engineering inputs into clear, testable, and traceable requirements.Maintain end-to-end requirements traceability between user needs, system requirements, subsystem requirements, verification activities, and regulatory documentation.Lead system-level risk management activities, including hazard analysis, FMEAs, risk controls, residual risk evaluation, and risk traceability in accordance with ISO 14971.Develop verification strategies and author verification protocols, test procedures, acceptance criteria, and reports to demonstrate compliance with system requirements.Plan, organize, and facilitate phased design reviews throughout development, ensuring technical readiness, documentation completeness, and cross-functional alignment.Coordinate closely with engineering teams to ensure design decisions, tradeoffs, and verification evidence are properly documented throughout the product lifecycle.Work alongside Quality and Regulatory to prepare the engineering content of FDA submissions, including device descriptions, verification summaries, risk documentation, software documentation, performance testing, and supporting technical reports.Support engineering investigations, root cause analyses, design changes, and CAPA activities by assessing system-level impacts and maintaining documentation consistency.Help establish and continuously improve systems engineering processes, documentation standards, and development workflows as Lambda scales.Ideal BackgroundBachelor's or Master's degree in Biomedical Engineering, Mechanical Engineering, Electrical Engineering, Systems Engineering, or a related engineering discipline.Approximately 3–5 years of experience developing regulated medical devices in a systems engineering, product development, R&D, or design assurance role.Experience developing and managing engineering requirements, requirements traceability, verification plans, and design documentation throughout the medical device development lifecycle.Strong understanding of medical device design controls, Design History Files (DHF), and product development under FDA Quality System Regulation and/or ISO 13485.Experience performing risk management activities under ISO 14971, including hazard analyses, FMEAs, risk control verification, and residual risk assessment.Experience authoring verification protocols, executing engineering verification activities, and producing high-quality technical reports suitable for regulatory submissions.Demonstrated ability to lead multidisciplinary engineering efforts spanning mechanical, electrical, firmware, software, and systems integration.Strong technical writing skills with exceptional attention to detail and an ability to communicate complex engineering concepts clearly.Experience supporting 510(k), De Novo, PMA, or international regulatory submissions is strongly preferred.Experience with surgical imaging, robotics, medical imaging, capital equipment, or other complex medical devices is a plus.Traits We ValueUtmost integrity. We need people who are honest, rigorous, trustworthy, and guided by a strong moral backbone and a genuine desire to do good with their time on earth. We value people who surface the truth quickly, even when it is inconvenient or difficult.High agency. We need people who take ownership, figure things out, create structure where it is missing, and drive ambiguous problems to resolution.Clear communication. We need people who can communicate clearly, directly, and thoughtfully across functions, including engineering, clinical, quality/regulatory, operations, leadership, partners, and customers.Other traits we value: curiosity, first-principles thinking, practical judgment, attention to detail, comfort with ambiguity, low ego, urgency, and excitement to build foundational technology for the future of surgery","datePosted":"2026-07-15T09:19:35.519Z","dateModified":"2026-07-15T09:19:35.519Z","hiringOrganization":{"@type":"Organization","name":"Lambda Surgical","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Somerville","addressRegion":"MA","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"a4a4e8b3c156b67555e8a063"},"url":"https://jobsearcher.com/jobs/a4a4e8b3c156b67555e8a063"}}