Lead Engineer, Systems

THINK Surgical

Lead Systems Engineer overseeing medical device lifecycle management and risk assessment in compliance with regulatory standards. Collaborating across teams to ensure design and functionality meet clinical needs.

Posted 4/25/2026full-timeRemote • California • 🇺🇸 United StatesSenior💰 $160,000 - $200,000 per yearWebsite

About the role

Key responsibilities & impact

Systems Requirements Definition: Develop and document detailed product-level and component-level requirements, ensuring alignment with clinical needs, user feedback, and safety critical system performance.
Risk Management: Conduct system-level risk analysis, identifying hazards and harms, and recommending control measures that meet medical device regulatory standards (ISO 14971).
Traceability: Ensure full traceability from requirements through design, implementation, testing, and verification to comply with medical device standards (ISO 13485, IEC 62304), ensuring that every system requirement is tested and verified.
Testing and Validation: Collaborate with the testing team to develop system-level test plans, protocols, and verification/validation activities to ensure the product meets functional and safety requirements.
System Integration: Lead the integration of multi-disciplinary components (software, hardware, mechanical) to ensure cohesive system functionality and performance in real-time surgical environments.
Regulatory Compliance: Ensure compliance with all relevant medical device regulations, including documentation for regulatory submissions. Provide technical support for regulatory audits and submissions.
Cross-functional Collaboration: Work closely with software, hardware, and mechanical teams to ensure design decisions are optimized for the overall system. Collaborate with product management, clinical engineering, and surgeons to ensure the system meets user requirements and delivers value.
Verification of Design: Lead the effort to verify that system designs meet system requirements through rigorous testing and simulation. Lead system design reviews to ensure requirements are met and safety standards are maintained. Drive system level risk identification and define robust risk control measures, including oversight of risk control implementation and verification of their effectiveness.
Validation of Design: Lead design reviews to ensure design outputs conform to approved design inputs and applicable regulatory requirements. Own design validation activities, including oversight and support for the preparation and maintenance of usability engineering deliverables in accordance with IEC 62366.
Change Management: Manage design changes and their impacts on system-level requirements, ensuring that changes are properly analyzed for risk and maintain compliance with regulatory standards.
Documentation: Lead the creation of system documentation, including requirements specifications, design documents, risk management files, and traceability matrices to ensure complete, clear, and compliant records throughout the development lifecycle.

Requirements

What you’ll need

Bachelor’s degree in computer science or computer/mechanical/electrical/biomedical engineering.
10+ years experience in medical device development.
Deep understanding of medical device regulatory standards (e.g., ISO 14971, ISO 13485, IEC 62304, IEC 60601, IEC 62366).
Good organizational skills and excellent communication and documentation skills.
Excellent problem solving skills.
Knowledge of Good Manufacturing Practices (GMP) and applicable Quality System Standards.

Benefits

Comp & perks

🌐 Worldwide ❌ Jobs You've Hidden ⭐️ Saved Jobs ✅ Applied Jobs ✉️ Email Alerts 👤 Account THINK Surgical Website LinkedIn All Job Openings 51 - 200 employees 🔧 Hardware ☁️ SaaS 🤝 B2B 💰 $5M Funding Round - THINK Surgical on 2023-06 Hardware
SaaS
B2B THINK Surgical is a medical robotics company that develops a miniature, wireless robotic system and accompanying software for orthopedic procedures, focused primarily on total knee replacement. Its product lineup includes the TMINI robotic system that assists surgeons intraoperatively, TPLAN, a 3D surgical planning platform created from patient CT scans, and the Implant Data Hub (ID-HUB) that enables implant-agnostic choice and integration. THINK Surgical sells to hospitals and surgical practices and aims to expand surgeon and hospital access to robotic orthopedic technology. Lead Engineer, Systems 🔥 2 minutes ago 🏄 California – Remote 💵 $160k - $200k / year ⏰ Full Time 🟠 Senior 🧑‍💻 Full-stack Engineer Apply Now Find Hiring Managers Customize resume for this job Report problem ☆ Save ☑️ Mark as applied ❌ Hide 📋 Description
Systems Requirements Definition: Develop and document detailed product-level and component-level requirements, ensuring alignment with clinical needs, user feedback, and safety critical system performance.
Risk Management: Conduct system-level risk analysis, identifying hazards and harms, and recommending control measures that meet medical device regulatory standards (ISO 14971).
Traceability: Ensure full traceability from requirements through design, implementation, testing, and verification to comply with medical device standards (ISO 13485, IEC 62304), ensuring that every system requirement is tested and verified.
Testing and Validation: Collaborate with the testing team to develop system-level test plans, protocols, and verification/validation activities to ensure the product meets functional and safety requirements.
System Integration: Lead the integration of multi-disciplinary components (software, hardware, mechanical) to ensure cohesive system functionality and performance in real-time surgical environments.
Regulatory Compliance: Ensure compliance with all relevant medical device regulations, including documentation for regulatory submissions. Provide technical support for regulatory audits and submissions.
Cross-functional Collaboration: Work closely with software, hardware, and mechanical teams to ensure design decisions are optimized for the overall system. Collaborate with product management, clinical engineering, and surgeons to ensure the system meets user requirements and delivers value.
Verification of Design: Lead the effort to verify that system designs meet system requirements through rigorous testing and simulation. Lead system design reviews to ensure requirements are met and safety standards are maintained. Drive system level risk identification and define robust risk control measures, including oversight of risk control implementation and verification of their effectiveness.
Validation of Design: Lead design reviews to ensure design outputs conform to approved design inputs and applicable regulatory requirements. Own design validation activities, including oversight and support for the preparation and maintenance of usability engineering deliverables in accordance with IEC 62366.
Change Management: Manage design changes and their impacts on system-level requirements, ensuring that changes are properly analyzed for risk and maintain compliance with regulatory standards.
Documentation: Lead the creation of system documentation, including requirements specifications, design documents, risk management files, and traceability matrices to ensure complete, clear, and compliant records throughout the development lifecycle. 🎯 Requirements
Bachelor’s degree in computer science or computer/mechanical/electrical/biomedical engineering.
10+ years experience in medical device development.
Deep understanding of medical device regulatory standards (e.g., ISO 14971, ISO 13485, IEC 62304, IEC 60601, IEC 62366).
Good organizational skills and excellent communication and documentation skills.
Excellent problem solving skills.
Knowledge of Good Manufacturing Practices (GMP) and applicable Quality System Standards. Apply Now 📊 Check your resume score for this job Improve your chances of getting an interview by checking your resume score before you apply. Check Resume Score Similar Jobs ICAM Software Developer 🔥 2 hours ago Arcarithm 51 - 200 🤖 Artificial Intelligence 🔒 Cybersecurity Website LinkedIn All Job Openings Software Developer tasked with designing and maintaining custom solutions for NASA's ICAM program. Collaborate with an agile team supporting cutting-edge technologies and operational needs. 🇺🇸 United States – Remote ⏰ Full Time 🟡 Mid-level 🟠 Senior 🧑‍💻 Full-stack Engineer Bootstrap Docker Java JavaScript Kubernetes Maven MS SQL Server OpenShift SOAP Spring Spring Boot SpringBoot SQL Senior Software Engineer 🔥 2 hours ago Avenu Insights & Analytics 501 - 1000 🏛️ Government 📋 Compliance ☁️ SaaS Website LinkedIn All Job Openings Software Engineer focused on designing and supporting Neumo’s Tax Administration SaaS applications. Collaborating with teams to deliver enhancements driven by regulatory requirements and client needs. 🇺🇸 United States – Remote ⏰ Full Time 🟠 Senior 🧑‍💻 Full-stack Engineer Angular Azure Cloud JavaScript React SQL Vue.js .NET Senior Fullstack Software Engineer, Kafka, Camunda 🔥 2 hours ago UBC 1001 - 5000 🧬 Biotechnology ⚕️ Healthcare Insurance 💊 Pharmaceuticals Website LinkedIn All Job Openings Senior Software Engineer focusing on AI enhancement of patient access solutions for pharmaceutical support leader UBC. Leading software development with emphasis on collaboration, innovation, and quality. 🇺🇸 United States – Remote ⏰ Full Time 🟠 Senior 🧑‍💻 Full-stack Engineer Azure Cloud Kafka Python React .NET Senior Fullstack Software Engineer, Kafka, Camunda 🔥 2 hours ago UBC 1001 - 5000 🧬 Biotechnology ⚕️ Healthcare Insurance 💊 Pharmaceuticals Website LinkedIn All Job Openings Senior Software Engineer focusing on AI enhancement for UBC's Patient Access and Support product lines. Leading development efforts and ensuring technological integrity in software solutions. 🇺🇸 United States – Remote ⏰ Full Time 🟠 Senior 🧑‍💻 Full-stack Engineer Azure Cloud Kafka Python React .NET Lead Software Engineer, Kubernetes 🔥 5 hours ago Ticketmaster 10,000+ employees 🛍️ eCommerce ⚽ Sports Website LinkedIn All Job Openings Lead Software Engineer focusing on Kubernetes within Ticketmaster’s TechOps division. Collaborating with global teams to support infrastructure systems and processes across various regions. 🇺🇸 United States – Remote 💵 $140k - $175k / year ⏰ Full Time 🟠 Senior 🧑‍💻 Full-stack Engineer Ansible Grafana Kubernetes Prometheus Python Rust Terraform Go View More Full-stack Engineer Jobs 🌐 Worldwide Built by Lior Neu-ner. I'd love to hear your feedback — Get in touch via DM or support@remoterocketship.com Search Search Jobs by country Search jobs by city Search jobs by job title Search entry-level jobs Search junior-level jobs Search senior-level jobs Search jobs by tech stack Search jobs by contract type Search remote internships Search remote part-time jobs Remote jobs Anywhere in the World Companies Hiring Anywhere in the World Companies Hiring Sales People Anywhere in the World Companies Hiring Software Engineers Anywhere in the World Resources Advice Tips for finding remote jobs Interview questions and answers Resume examples Cover letter examples Post a job Affiliates Privacy policy Terms of service Job board SEO course AI Apply Copilot OpenClaw job finder Jobs by Country Remote jobs anywhere in the world (Worldwide remote jobs) Remote jobs United States Remote jobs Australia Remote jobs Brazil Remote jobs Canada Remote jobs France Remote jobs Ireland Remote jobs Germany Remote jobs Netherlands Remote jobs Spain Remote jobs UK Popular Jobs Remote data analyst jobs Remote customer support jobs Remote executive assistant jobs Remote marketing jobs Remote product designer jobs Remote product manager jobs Remote project manager jobs Remote recruiter jobs Remote sales jobs Remote software engineer jobs Jobs by Type Remote full-time jobs Remote part-time jobs Remote contract jobs Remote internship jobs Remote entry-level jobs Remote jobs with no experience required Remote junior jobs (1-3 years of experience) Digital nomad jobs Remote jobs with no degree required Freelance remote jobs Temporary remote jobs Remote jobs hiring now Stay at home mom jobs

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Hard Skills & Tools

requirements definitionrisk analysissystem testingsystem integrationdesign verificationdesign validationchange managementdocumentationGood Manufacturing PracticesQuality System Standards

Soft Skills

organizational skillscommunication skillsdocumentation skillsproblem solvingcross-functional collaboration

Certifications

Bachelor’s degree in computer scienceBachelor’s degree in mechanical engineeringBachelor’s degree in electrical engineeringBachelor’s degree in biomedical engineering