Validation Engineer II

Join our dynamic sustaining team as a Design Engineer, where you will play a pivotal role in enhancing existing products. Your expertise in 3D CAD software will be critical as you create innovative concepts and detailed modeling and drafting designs. Your responsibilities will encompass drafting design history file documents, developing comprehensive test plans to evaluate designs, and collaborating across teams to ensure seamless Manufacturing, Quality Control, Regulatory, and Planning processes for your projects.Key Responsibilities Utilize SolidWorks to design and develop cutting-edge implants and instruments. Contribute to new product development and manufacturing process improvements as an integral member of the development team. Assist in the creation of working models for design evaluation purposes. Develop protocols for testing and analyzing both new and existing products. Prepare design assurance documentation for the project’s Design History File (DHF). Collaborate on the development of inspection methodologies. Propose design changes to optimize manufacturability while preserving essential features for both in-house and vendor manufacturing. Engage with cross-functional product development teams to guide new product development from conception through to launch. Support Project Engineers in providing technical insights for marketing collateral development. Assist Project Engineers in conveying design functions to Marketing and Sales teams. Provide technical expertise to Regulatory Affairs to assist with FDA 510(k) submissions and international registrations. Generate and process Change Orders (COs). Perform other duties as assigned.

Company Overview:Airspace is an innovative, tech-driven freight forwarding company that is revolutionizing the delivery of the world's most essential packages. With our headquarters located in Carlsbad, California, and a European base in Amsterdam, Netherlands, we pride ourselves on our global presence. Our team is recognized as a leader in AI and machine learning, utilizing our proprietary technology to seamlessly coordinate logistics through a worldwide network of drivers and airlines. Our mission is to ensure that mission-critical items, ranging from organs for transplant to vital machinery parts and sensitive components like semiconductors, are delivered faster, more transparently, securely, and accountably than ever before.Our accomplishments include being recognized as one of America’s Best Startup Employers, named a CNBC Disruptor 50 company, and featured as an Innovation and Disruption leader by CBS News. Backed by prominent investors such as Telstra Ventures, HarbourVest Partners, and more, we have successfully raised over $140 million to date.

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.

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.

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.

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.

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.

Atec Spine is seeking a highly skilled Senior Data Scientist to spearhead the creation, development, and integration of innovative intraoperative guidance solutions utilizing fluoroscopic images. This pivotal role is dedicated to enhancing Image Landmark Detection, refining C-arm calibration algorithms, and advancing intraoperative navigation algorithms. The goal is to provide spine surgeons with precise, real-time surgical feedback. The ideal candidate will possess a robust technical background in image processing, coupled with a deep understanding of surgical workflows, and will be tasked with developing algorithms for 3D spatial guidance through advanced techniques such as image processing, image stitching, calibration, and depth correction.Key Responsibilities:Drive the definition, development, and enhancement of system-level accuracy for C-arm fluoroscopic imaging processing and landmark detection.Innovate algorithms for stitching multiple fluoroscopic images while maintaining spatial orientation and accuracy.Collaborate with cross-functional teams, including clinical research, marketing, and surgeons, to translate user requirements into effective algorithmic solutions.Guide team members in the development of advanced image processing algorithms aimed at improving captured image quality.Design and implement system and subsystem tests throughout the development phase, prior to verification and validation (V&V).Assist in compliance testing and product certification processes, including IEC 60601-1 standards.Work alongside project managers or oversee projects to ensure timely and budget-conscious delivery.Participate in and support Design Control Phase reviews.Generate detailed design documentation for seamless hand-off to V&V teams while mentoring others in formal test methods development.Proactively identify and communicate testing challenges to foster cross-functional alignment.Execute additional related tasks as assigned.Qualifications:In-depth knowledge of image processing techniques, including stitching, calibration, and depth correction.Proven leadership capabilities within cross-functional technical teams.Familiarity with FDA medical device regulations and compliance standards.Strong documentation skills for processes, procedures, and results in alignment with regulatory requirements.Education and Experience:Master’s degree in Engineering, Physics, Mathematics, or a related field (e.g., Computer, Electrical, Mechanical, Systems Engineering).A minimum of 5 years of experience in product development, particularly in the medical device sector.2 to 3 years of direct experience with fluoroscopic image processing.Preferred Qualifications:Ph.D. in Engineering, Physics, or Mathematics.Experience with surgical navigation systems and intraoperative imaging technologies.

Join Tessenderlo Group as an Instrumentation and Electrical Designer where you will play a pivotal role in delivering innovative solutions in our operations. This dynamic position focuses on designing instrumentation and electrical systems that enhance productivity and safety across our plants.Your expertise will contribute to the development and implementation of advanced designs, ensuring compliance with industry standards and best practices. Collaborate with cross-functional teams to bring projects from concept to completion while optimizing performance and efficiency.

As a Product Manager for Robotics & Navigation at Atec Spine, you will play a pivotal role in shaping and executing product strategies, marketing initiatives, and promotional activities. You will manage every facet of product management, including market launches, ongoing product surveillance, and sales forecasting for your designated product line, ensuring alignment with company objectives and expectations.Key Responsibilities:Design and implement targeted product marketing campaigns, defining objectives and both short- and long-term strategies through thorough market research and competitive analysis.Evaluate market dynamics, sales performance, and consumer behavior to adapt product strategies accordingly.Create compelling business cases to support the development of new products as needed.Oversee all marketing activities related to your product line, including project management and market launch initiatives.Explore opportunities for product line extensions, adjustments, labeling changes, and clinical studies to enhance product value and profitability.Pursue innovative solutions for your product line consistently.Develop high-quality sales materials and effective customer service protocols to support product management.Collaborate with cross-functional teams to generate accurate sales forecasts and optimize the product mix throughout its lifecycle.Stay informed on market trends by reviewing scientific literature, analyzing competitors, engaging with field sales teams, attending surgeries, and participating in scientific meetings.Prepare product presentations, surgical techniques, and white papers to bolster sales and marketing efforts, including product binders and online resources.Monitor product development progress and liaise with engineering, manufacturing, regulatory affairs, and other relevant departments to ensure efficient execution of the strategic plan.Work closely with sales teams to provide robust support for new product launches and training programs.Build and maintain strong relationships with consulting physicians and stakeholders.Interface regularly with managers and directors of other product lines to understand the interconnectedness of product portfolios.Support the Medical Education department by assisting in surgeon and sales training courses, which may include theoretical and hands-on labs.

As the Design Manager at Vuori, Inc., you will spearhead the design of our retail spaces, ensuring each store embodies our brand ethos. You will provide innovative design support for new store openings, remodels, pop-ups, and special projects. Collaborating with our development team—which encompasses real estate, construction, visual merchandising, and marketing—you will play a pivotal role in shaping our retail presence both nationally and internationally.Key Responsibilities:Develop initial test fit floor plans, facade designs, signage concepts, and detailed drawings to communicate design intent effectively.Collaborate with internal departments such as Real Estate, Construction, Visual Merchandising, Marketing, and Operations to align store designs with brand standards.Work closely with the VP of Development and Senior Design Manager to implement the design vision while maintaining brand and operational standards.Prepare presentation materials for design concepts, including plans, 3D renderings, hand sketches, inspiration boards, and material samples for senior management reviews.Manage external Architects of Record and design teams throughout all project phases (Due Diligence, SD, DD, CD, and CA).Coordinate with permit expeditors and AOR to ensure timely regulatory approvals.Oversee and forecast the schedule for assigned projects, providing weekly updates to the Development team.Review and approve architectural plans, elevations, and shop drawings to ensure accuracy and compliance with brand standards.Conduct weekly meetings with external consultants and internal cross-functional teams.Collaborate with vendor partners on design execution, shop drawings, purchase orders, and schedules.Negotiate and manage design budgets and contracts with consultants.Stay updated on current trends in global culture, retail design, architecture, fashion, and art.Assist in developing and maintaining store design standards and prototype documentation.

Join Vuori Inc. as a Digital Designer, where creativity meets functionality! In this role, you will collaborate with our talented creative marketing team to design visually stunning digital assets that reflect our brand's ethos and drive engagement.Your innovative mindset will be pivotal in creating compelling graphics, layouts, and user interfaces that enhance our digital presence across various platforms. We're looking for someone who is not only technically proficient but also possesses a keen eye for aesthetics and detail.

The Concept & Styling Designer will play a pivotal role in executing the Women’s Design Team’s seasonal creative vision. Collaborating closely with the Director of Women’s Design, the VP of Women’s Design, and various cross-functional partners in merchandising and marketing, this position will enhance the communication of design concepts. By developing captivating visual presentations, coordinating styling initiatives, and managing digital design resources, this role will significantly contribute to the creation of commercially successful apparel.Key Responsibilities:Design and maintain visual aids, including mood boards, concept decks, and cross-functional tools.Assist in styling and outfitting by preparing garments and resources for photoshoots, presentations, and various visual communication efforts.Collaborate with design partners and cross-functional teams, including merchandising and marketing, to ensure alignment on design concept updates.Conduct trend research, sourcing inspiration from shopping trips, cultural events, publications, and online platforms, with a focus on contemporary styling trends.Organize and maintain design files and samples, adhering to the team’s digital and physical asset management systems.Support the management of seasonal interns, fostering positive learning experiences and brand knowledge.

Join our dynamic team at Artech Information Systems LLC as a Medical Collections Representative. In this role, you will be pivotal in managing medical billing and collections, ensuring timely payments while providing exceptional service to patients and healthcare providers. Your expertise in navigating insurance claims and patient inquiries will help streamline our collections process, contributing to our commitment to financial integrity and patient satisfaction.

Jam City, a trailblazer in mobile game development, is on the lookout for visionary talent to elevate our creative team. We are seeking dynamic individuals who thrive in collaborative, fast-paced environments and are keen to push the boundaries of mobile gaming.PERKS & BENEFITSEnjoy unlimited vacation, paid sick days, recharge days, and holidays.Comprehensive medical, dental, and vision coverage fully funded for employees.Life insurance, 401k plans, flexible spending accounts, and more.Participate in happy hours and company events.We are seeking an experienced Lead Puzzle Designer to lead the charge on an exciting new puzzle game. The ideal candidate will possess a blend of exceptional creative talent, strong leadership capabilities, and a deep understanding of the mobile free-to-play (F2P) market. As the Lead Puzzle Designer, you will be responsible for ensuring the overall quality, creative vision, and market success of our puzzle titles.*Note: While we prefer local candidates from the greater San Diego area, we are open to remote opportunities for the right individual.

Join our innovative engineering team at Essel Environmental as a Civil 3D Designer/Drafter, where your expertise will contribute to groundbreaking civil engineering projects. In this essential role, you will support the design and drafting processes for diverse projects, including land development, transportation systems, and municipal infrastructure.Your main tasks will involve leveraging AutoCAD Civil 3D to create precise design models, drafting comprehensive plans, and generating documentation that complies with industry standards. Collaboration with engineers and project managers will be vital to ensure design accuracy and functionality while adhering to project specifications and timelines.Key Responsibilities:Develop and adjust 2D and 3D designs using AutoCAD Civil 3D for grading, drainage, and alignment of civil engineering projects.Produce construction drawings, including site plans, utility plans, and cross-sections.Contribute to civil engineering reports and technical documentation.Review and verify plans for compliance with project specifications and local codes.Work closely with project teams to maintain accuracy and currency in design work.Conduct field surveys and gather relevant data to inform design processes.

The Women's Fashion Designer will spearhead the design process across a diverse range of women's apparel categories, including tops, bottoms, outerwear, dresses, sweaters, swimwear, and more. This role emphasizes trend forecasting and market analysis, brand identity, customer engagement, and the creation and management of detailed tech packs to ensure consistency across categories. Collaboration with merchandising, technical design, product development, and production teams is crucial to deliver innovative, customer-centric, and sustainable designs.Trend & Market Insight• Track global fashion trends, street style, trade exhibitions, social media, and competitors to spot emerging themes and market opportunities.• Collaborate with the Creative Director and Merchandising team to distill trend insights into concept presentations for seasonal directions, including mood boards, color palettes, and silhouettes.• Transform macro and micro trend analyses into actionable design strategies tailored for our target demographic.Cross-Category Design Leadership• Lead design initiatives across all women's categories to ensure a cohesive brand message and technical feasibility.• Foster creativity in silhouette, fabric selection, construction, detailing, prints, and embellishments across categories.• Work alongside product development and print teams to conceptualize and implement materials and surface treatments that align with seasonal themes.Design Execution & Collaboration• Create sketches and CAD designs for presentation and feedback.• Develop flat drawings, technical specification sheets, and select appropriate fabrics and trims.• Uphold our sustainability values by ensuring that fabric and trim selections are environmentally compliant.• Engage in design reviews, internal critiques, and cross-functional meetings.• Assess incoming samples for accuracy in fit, detail, color, finishing, and wash.• Provide feedback on lab dips, strike-offs, and other vendor submissions.• Participate in prototype reviews and fittings, offering guidance to product development and technical design.• Collaborate with product development to monitor the progress of styles under development, ensuring product execution aligns with design intent.

The Associate Designer for Men's Concept & Styling will be a vital contributor to the Men’s Design Team, assisting in the execution of the seasonal creative vision. This role involves close collaboration with the Director of Men’s Lifestyle and Outerwear Design, as well as partners in merchandising and marketing, to effectively translate design concepts into reality through impactful visual tools, styling execution, and well-organized creative systems. This position is perfectly suited for a detail-oriented, highly efficient creative individual with exceptional taste and a keen awareness of contemporary styling trends.Key Responsibilities:Assist in the creation and upkeep of visual aids, including mood boards, concept presentations, seasonal styling guides, and cross-functional assets.Quickly execute updates to seasonal concept presentations and digital platforms, ensuring consistency across teams.Prepare for stage gates by organizing presentation materials, styling looks, managing samples, and ensuring all visual communication assets are ready.Support styling and outfitting tasks by preparing garments and tools for photoshoots, internal reviews, and presentations.Collaborate with design, merchandising, and marketing teams to ensure design updates are accurately reflected.Conduct trend research and market analysis for men's styling and product relevance, drawing inspiration from retail, cultural moments, and digital platforms.Maintain organized digital and physical design files, adhering to established asset management systems.Manage seasonal samples, ensuring precision and readiness for fittings and creative meetings.Assist in mentoring seasonal interns, fostering an organized and inspiring team environment.

Role Overview Vuori Inc. is hiring a Design Operations Manager in Carlsbad, California. This position focuses on improving how our design department works day to day. The role centers on refining processes, supporting team collaboration, and helping the design group run smoothly. What You Will Do Streamline design workflows and processes Encourage strong collaboration within the design team and with other departments Work with cross-functional groups to keep design efforts aligned with Vuori’s brand direction and goals Identify areas for operational improvement and put solutions in place Location This role is based in Carlsbad, California.