Design Engineer - Innovative Medical Device Solutions

As a Validation Engineer II at Atec Spine, you will play a crucial role in the design and execution of software verification activities for cutting-edge medical devices. This mid-level position involves close collaboration with cross-functional teams, including Research and Development, Software Engineering, Quality Engineering, Mechanical Engineering, Marketing, and Regulatory Affairs, to ensure that our innovative products adhere to FDA, ISO, and IEC standards.Your responsibilities will encompass a diverse array of software-enabled medical devices, covering areas such as intraoperative neuromonitoring, surgical alignment, robotic navigation, and a comprehensive cloud-based platform.The ideal candidate will possess hands-on experience in validating software-based medical devices, strong technical and troubleshooting skills, and excellent documentation and communication abilities. You will be expected to work effectively within a team-oriented environment.Key Responsibilities:Lead verification and validation (V&V) activities for assigned projects, ensuring adherence to quality, timelines, and compliance standards while collaborating with cross-functional teams.Define and implement verification strategies for new product development, crafting comprehensive test plans and protocols.Contribute to the enhancement of V&V practices by identifying areas for improvement, streamlining processes, and engaging in collaborative problem-solving initiatives.Draft and review design control documentation, ensuring that requirements, test plans and protocols, test reports, and traceability matrices comply with FDA and internal quality standards.Design, develop, and validate both manual and automated system-level test methodologies.Conduct validation of non-medical device software tools and supporting systems as necessary, ensuring thorough documentation and rigor.Participate in risk management activities as per ISO 14971, contributing to hazard analysis, risk control measures, and verification of risk mitigations.Engage with senior validation engineers for guidance and may assist in onboarding and knowledge transfer for junior team members.Maintain consistent attendance at the primary worksite.Perform other related duties as assigned.

As a Senior AI Validation Engineer at ATEC Spine, you will spearhead the validation processes for AI/ML-integrated software and software-driven medical device systems throughout the phases of new product development and ongoing engineering efforts. This pivotal position operates with a high degree of autonomy, providing advanced technical insights into AI model validation, data governance, risk management, and adherence to regulatory standards, thereby ensuring that AI-enabled medical devices comply with FDA and international regulations over the entire product lifecycle.You will collaborate extensively with teams across Quality Engineering, R&D, Data Science, Clinical, Product Development, and Regulatory Affairs to uphold scientific integrity, transparency, bias reduction, and traceability in AI/ML system validation.Key Responsibilities:Lead the verification and validation initiatives for ATEC’s AI/ML-enabled software solutions.Formulate AI validation strategies, protocols, and testing methodologies.Design and manage validation datasets, develop ground truthing techniques, and generate ground truth data.Establish performance metrics, acceptance criteria, and statistical methodologies in alignment with intended applications.Execute performance validation studies, including statistical evaluations and data processing, and compile comprehensive study reports.Evaluate and document model limitations, potential biases, and the representativeness of data.Oversee data management associated with validation efforts, ensuring independence of datasets and proper training/validation/test separations.Assist in risk management activities as per ISO 14971, focusing on AI-specific hazards and potential failure modes.Prepare and review Computer Software Validation (CSV) documentation in accordance with FDA guidelines.Contribute AI/ML validation documentation for FDA submissions (510(k), De Novo, PMA).Work collaboratively to ensure regulatory preparedness and provide technical support to various departments.Perform other related tasks as assigned.

Join ATEC Spine in advancing cutting-edge technologies through impactful functional biomechanics research and clinical validation initiatives. In this dynamic role, you will collaborate across departments to design and execute studies, manage and analyze complex multi-modal datasets, and articulate findings in comprehensive technical documentation and scientific communications that showcase product efficacy and clinical relevance.Key Responsibilities:Assist in developing and validating innovative workflows for objective functional measurement methods, including wearable sensors, electromyography, computer vision, and force plates.Work collaboratively to identify research gaps and align studies with business and product goals.Support the performance testing strategy for clinical validation of ATEC products, encompassing imaging, navigation, and robotics technologies.Design and execute clinical research protocols focusing on functional biomechanical assessment techniques and enabling technology performance.Organize and oversee extensive datasets from research studies, ensuring precision, traceability, and proper documentation.Critically analyze and interpret data across various modalities.Draft clear and thorough technical engineering documentation.Contribute to the dissemination of scientific results through presentations, reports, and publications, assisting investigators and clients with research findings.Collaborate with the Scientific Affairs team to ensure alignment of research activities and gather necessary technical and clinical support.Address moderate scope problems requiring a thorough analysis of diverse factors.Utilize sound judgment to navigate defined procedures and practices in decision-making.Receive general instructions for routine tasks and detailed guidance for new projects.

The Software Test Engineer II at Atec Spine will collaborate in testing client applications for the IOA/IOB/SafeOp platform. This role entails active involvement in every phase of the software development life cycle, including ongoing support. Projects will encompass a variety of platforms including Windows applications, embedded systems, and data aggregators/gateways.Key ResponsibilitiesCollaborate with a test lead within a development team to execute complex software testing activities, including the design and implementation of software test plans and cases to ensure quality, reliability, and design compliance.Analyze functional and business requirements, developing test automation when suitable.Conduct both automated and manual testing in a continuous integration environment to validate software quality.Perform integration and system-level testing for software and hardware systems.Contribute to innovation and process enhancement initiatives.Estimate tasks and manage software projects according to established project timelines.Communicate proactively, transparently, and concisely regarding project progress.Create documentation related to software development projects (e.g., design artifacts, test plans/cases).Work efficiently within globally distributed teams.

The Pricing Analyst II at Airspace will focus on developing and improving pricing strategies that support the company’s business objectives. Based in Carlsbad, CA, this role plays a key part in helping Airspace stay competitive and responsive to changing market conditions. Main responsibilities Build and refine pricing strategies to align with business goals Collaborate with teams across the company to ensure pricing reflects current market trends and customer needs Provide insights that influence revenue growth and strengthen Airspace’s market position Collaboration This position works closely with multiple departments, sharing analysis and recommendations to keep pricing relevant and effective. Impact Work from this analyst helps guide company decisions on pricing, directly supporting Airspace’s growth and competitiveness.

Join Sonsoft Inc. as a DevOps Engineer, where you will be integral in enhancing our software development lifecycle. You will collaborate with cross-functional teams to streamline operations, automate processes, and ensure the seamless deployment of applications. Your expertise will contribute to optimizing our infrastructure and improving application performance.

The Senior Systems Engineer will spearhead the design and integration efforts for cutting-edge surgical navigation and robotics systems. This pivotal role involves managing the entire product life cycle, from collaborating with marketing to define user needs, conducting early characterization work, and authoring and managing requirements, to executing technical solutions, overseeing verification and validation processes, and facilitating design transfers and complaint investigations. The ideal candidate will excel in collaborating across various engineering disciplines (mechanical, electrical, and software) as well as with other organizational departments (regulatory, marketing, operations, quality, etc.).Key Responsibilities:Define, develop, and enhance system-level accuracy for surgical navigation and robotics platforms, ensuring compliance with clinical, regulatory, and business requirements.Author and guide the creation of design, construction, and characterization guidelines for navigated arrays and surgical instruments.Lead the integration of complex systems, encompassing mechanical, software, and electrical components.Work closely with internal stakeholders (clinical research, marketing, surgeons, etc.) to refine user needs, effectively capturing and articulating user requirements to the engineering team.Drive development activities during the concept phase to explore innovative ideas and technologies, ensuring technical readiness for subsequent development stages.Develop and implement system and sub-system testing throughout the development phase prior to verification and validation.Support compliance testing and product certifications relevant to the system, including IEC 60601-1 testing.Demonstrate expertise in ASTM F2554-22.Oversee and maintain Design History Files, creating and submitting Change Orders as necessary.Establish and maintain product risk management files, facilitating risk-based discussions with other engineering teams.Guide the preparation of technical documents for FDA 510(k) submissions or other regulatory filings as required.Collaborate with project managers or directly manage projects to ensure timelines are met within budget constraints.Lead or assist in Design Control Phase reviews.Be a critical resource in driving verification and validation activities, ensuring design documentation is comprehensive for handoff to the V&V team, mentoring in the development of formal testing methods, and proactively addressing testing challenges to foster cross-functional engagement.Perform additional duties as assigned.

About the Role Hydrosat is seeking a Mechanical Engineer to join the team in Carlsbad, California. This role centers on developing advanced optical payloads for space deployment. The work involves both mechanical and opto-mechanical design for multispectral space payloads. What You Will Do Design and develop mechanical and opto-mechanical components for space-based optical systems Collaborate with an experienced engineering team throughout the design and development process Create and analyze mechanical designs for payload hardware Conduct thorough testing on prototypes and hardware to prepare for manufacturing Support the build, testing, and qualification phases of the space payload Who We’re Looking For Experience developing and testing optical systems for space applications Background in mechanical and opto-mechanical design Ability to support hands-on testing and qualification of hardware This position is based in Carlsbad, California, United States.

Atec Spine is seeking an experienced Senior Software Engineer, Web, to join our dynamic team focused on enhancing the Informatix platform through innovative web applications. This role offers an exciting opportunity to engage in the full software development lifecycle — from defining requirements and designing solutions to developing, deploying, maintaining, and optimizing performance.Key Responsibilities:Lead the development of user interface components for web applications to meet specific project needs.Set up and configure server environments specifically for Vue.js deployments.Collaborate with fellow web developers and software engineers to create a robust and adaptable front-end architecture.Perform performance testing, pinpoint optimization opportunities, and drive continuous improvements.Estimate tasks and execute software projects in alignment with project timelines.Mentor junior developers and oversee the comprehensive delivery of modules.Maintain clear and proactive communication regarding project statuses.Generate documentation pertinent to software development projects, including design artifacts and test plans.Work effectively with distributed teams around the globe.

As a Lifecycle Marketing Retention Specialist II at Vuori, you will play a pivotal role in enhancing customer engagement through the execution and optimization of lifecycle marketing strategies via email and SMS. Your primary focus will be on lifecycle execution, experimentation, and performance improvement, while also supporting loyalty initiatives that intersect with customer engagement.Collaboration will be vital in this role, as you will work closely with teams across Marketing, Creative, Technology, Analytics, Retail, and Merch Planning to ensure cohesive and on-brand communications across various channels. This position serves as a solid foundation for future growth in CRM and lifecycle marketing, providing valuable hands-on experience within a dynamic, fast-growing brand.The ideal candidate is passionate about lifecycle and retention marketing, thrives in a fast-paced environment, and possesses a detail-oriented, data-driven approach to execution and testing.Key Responsibilities:Lifecycle Marketing (Primary Focus)Act as a vital member of the retention team, executing lifecycle email and SMS campaigns aimed at boosting customer engagement and retention.Conduct lifecycle marketing tests (e.g., A/B testing, segmentation strategies, triggered journeys) to enhance performance and strengthen customer relationships.Assist with the quality assurance, testing, and deployment of campaigns within CDP and ESP platforms.Monitor and analyze performance metrics, providing insights and reports for continuous optimization.Collaborate with creative, copy, site merchandising, and acquisition teams to ensure brand consistency and alignment.Manage campaign assets, timelines, and workflows alongside creative and project management teams.Maintain open channels of communication with stakeholders to guarantee the timely and accurate execution of lifecycle initiatives.Loyalty SupportSupport loyalty initiatives related to lifecycle marketing, including triggered communications, customer journeys, and testing associated with loyalty moments.Work closely with Loyalty leads to operationalize loyalty-related lifecycle campaigns within email and SMS channels.Assist in extracting performance insights from lifecycle campaigns to inform loyalty optimization and future strategies.Email & SMS MarketingDevelop and schedule email campaigns using the ESP.Collaborate with creative teams on copy, asset coordination, and layout execution.Generate post-send performance reports to identify trends and insights.

About Us: At Protillion Biosciences, we are at the forefront of transforming therapeutic development through our innovative high-throughput systems. Our commitment to revolutionizing drug discovery is matched only by our passion for fostering a collaborative and dynamic workplace. About the Role: We are on the lookout for a seasoned scientific instrument software engineer who will spearhead the software development for our advanced high-throughput protein analysis platform. Job Responsibilities: Oversee the development of instrument control software for our scientific instrument platform. Collaborate closely with scientific and engineering teams to create comprehensive software development plans outlining project goals, scope, requirements, deliverables, timelines, and milestones. Take charge of executing all phases of the software development lifecycle: requirements analysis, architecture, design, coding, documentation, testing, deployment, configuration management, and ongoing support. Requirements: Bachelor's or Master's/Ph.D. in Computer Science, Computer Engineering, Electrical/Mechanical/Chemical Engineering, or Physics with significant experience (8+ years for BS/BA or 6+ years for MS/Ph.D.). Proven track record in developing intricate software for sophisticated scientific instruments or automated systems. Strong proficiency in the following technologies: Python Qt Git, GitHub Windows Asynchronous programming Image processing (ImageJ) Serial port communication Agile methodologies What We Offer: Competitive salary and benefits package. Opportunity to work on cutting-edge technology and innovative therapeutics. A collaborative and inclusive workplace culture. Professional development and growth opportunities. Protillion is proud to be an equal opportunity employer. We celebrate diversity and strive to create an inclusive environment for all employees. Compensation Range: $155,000/yr - $205,000/yr

Vuori, Inc. is looking for a Retail Process Improvement Specialist II based in Carlsbad. This entry-level position centers on making retail operations more efficient and effective. Role overview The main focus is to identify and enhance processes that support store teams. By refining workflows, this role helps create a better experience for both staff and customers. What you will do Work on projects that improve day-to-day retail operations Support store teams as they implement new or updated procedures Contribute to a consistent and positive customer experience by streamlining workflows Who this role suits This position is a good fit for someone interested in process improvement and retail operations. Curiosity about how stores run and a desire to help teams work more smoothly will serve well here.

Join ATEC Spine as a Senior Systems Engineer, where you'll spearhead the design and development of cutting-edge surgical, navigation, and informatics platforms. In this pivotal role, you will oversee systems throughout their life cycles, from refining user needs to verifying and validating designs.Collaboration is key! You will work closely with multi-disciplinary teams including mechanical, electrical, software, clinical, and quality/regulatory experts to ensure the creation of robust and compliant system architectures that deliver exceptional performance. Additionally, you will provide technical leadership and mentorship to junior engineers, fostering a culture of excellence in systems engineering.Key ResponsibilitiesSystems Engineering LeadershipDirect the development, breakdown, and management of system and subsystem requirements following INCOSE best practices.Establish system architecture, interfaces, and integration strategies for complex systems that encompass software, hardware, and mechanical components.Conduct trade studies, risk analyses, and hazard assessments while supporting design control activities for regulated medical devices.Act as the technical authority for system performance, usability, and clinical workflow in spine surgery contexts.Assist in compliance and product safety measures, including IEC 60601 evaluations and related certification testing.Cross-Functional CollaborationEngage with marketing, clinical, software, hardware, and quality/regulatory teams to refine user expectations and ensure smooth subsystem integration.Lead cross-functional design reviews and provide analytical insights through modeling and systems-level analysis.Partner with Quality and Regulatory teams to ensure traceability of requirements and preparation of submission-ready documentation (e.g., 510(k) inputs).Create comprehensive design documentation for verification and validation efforts, engaging early to determine testing requirements.Project & Technical LeadershipGuide and mentor junior engineers, reinforcing best practices in Systems Engineering.Oversee major engineering projects as the primary systems owner, ensuring alignment with timelines, risk management, and business goals.Maintain a strong presence in daily project execution to ensure structure and alignment across engineering teams.Implement project management strategies to drive schedules, manage risks, and support program milestones.

Join our dynamic team at Sonsoft Inc as a DevOps Engineer, where you will play an essential role in streamlining development processes and enhancing operational efficiency. We are looking for a passionate individual who thrives in a collaborative environment and is eager to tackle challenges in cloud infrastructure, automation, and continuous integration and delivery.

Join our dynamic team at Sonsoft Inc. as a DevOps Engineering Manager, where you will lead and inspire a talented group of engineers to innovate and enhance our continuous integration and deployment practices. This pivotal role requires a blend of technical expertise and leadership skills to drive efficiencies and improve system reliability.

We are seeking a talented and driven DevOps Engineering Manager to lead our dynamic team at Sonsoft Inc. in Carlsbad, California. In this role, you will be responsible for managing the DevOps team, enhancing our CI/CD pipelines, and implementing innovative solutions to streamline our operations.Your expertise will be vital in fostering a collaborative environment and ensuring the successful delivery of high-quality software products.

As a key member of our engineering team, the Staff Manufacturing Engineer plays a pivotal role in leading manufacturing engineering initiatives that support the innovative development, commercialization, and production of advanced medical devices. This position is responsible for overseeing a diverse portfolio of products produced chiefly by contract manufacturers, driving substantial improvements in cost-efficiency, lead times, manufacturability, and operational performance.Collaboration is at the heart of this role; you will work cross-functionally with teams including Product Development, Sustaining Engineering, Quality Assurance, Supply Chain, and external manufacturing partners to ensure the development of robust manufacturing processes and scalable production capabilities.Key Responsibilities:Act as the primary technical manufacturing resource for product development, spearheading initiatives aimed at reducing costs, enhancing lead times, improving yields, and ensuring process robustness at contract manufacturers.Develop and implement manufacturing strategies across the product portfolio, focusing on cost reduction, scalability, and operational excellence.Facilitate the identification and technical evaluation of external manufacturing partners for complex medical devices, fostering strong relationships.Lead technical design reviews and oversee the transfer of specifications from R&D to internal and external suppliers, ensuring cost-effective manufacturability through Design for Manufacturing (DFM), Design for Inspection (DFI), and Design for Assembly (DFA) principles.Serve as the technical authority for design transfer and new product introduction (NPI), ensuring a seamless transition from development to production.Guide the development and validation of manufacturing processes (IQ/OQ/PQ) for both new and existing products.Collaborate with internal teams and external suppliers to troubleshoot manufacturing issues and enhance process capability, yield, and throughput.Establish and uphold technical standards within the engineering organization while mentoring junior engineers.Lead Failure Mode and Effects Analysis (FMEA) efforts to mitigate risks to product quality and patient safety.Investigate nonconformances, implementing corrective and preventive actions (CAPA) as necessary.Analyze manufacturing data to identify trends, driving continuous improvement initiatives.Develop and maintain comprehensive work instructions and documentation for manufacturing processes.Other duties as assigned.

Become a Key Player at BKF Engineers as a Senior Project SurveyorAre you ready to take your surveying career to the next level? BKF Engineers is on the lookout for a dedicated Senior Project Surveyor to enhance our dynamic team in Carlsbad, California. In this pivotal role, you will lead survey project delivery, manage team coordination, and uphold our quality standards. Your expertise will guide technical decision-making, mentor junior staff, and uncover opportunities for additional services. You'll play an essential role in proposal development, project meetings, and client engagement while actively contributing to business growth by promoting BKF's exceptional services and identifying new project prospects.Key Responsibilities:Prepare construction staking calculations by accurately interpreting plans and CAD files.Create various mapping deliverables, including boundary surveys, ALTA surveys, topographic surveys, plats, and legal descriptions.Post-process field data utilizing total stations, GPS, levels, 3D laser scanners, and UAV technology.Construct 3D models of sites and structures for collaboration with owners, architects, engineers, and contractors.Willingness to travel to different job sites and offices as needed.

As a Senior Design Engineer at Alphatec Spine, you will play a pivotal role in the innovation and enhancement of our product line. Your primary focus will be on the design and development of cutting-edge surgical instruments, leveraging advanced 3D CAD software, particularly SolidWorks. You will be integral to drafting design history file documents, formulating test plans to evaluate designs, and collaborating on production processes across Manufacturing, Quality Control, Regulatory, and Planning departments.Key Responsibilities Design and develop surgical instruments using SolidWorks. Contribute to new product development and improvement of manufacturing processes. Assist in creating working models for design assessments. Develop protocols for the testing and analysis of products. Prepare and maintain design assurance documentation for the Design History File (DHF). Work collaboratively to establish inspection methods. Initiate and implement design modifications to enhance manufacturability while preserving critical features. Collaborate on cross-functional teams from concept through product launch. Provide technical insights to marketing teams for the development of promotional materials. Support Project Engineers with regulatory submissions and compliance documentation. Generate and process Change Orders (COs). Perform additional tasks as required.