Manager of Engineering (Multidisciplinary Hardware) OptopaxManager of Engineering (Multidisciplinary Hardware)San Jose, CaliforniaWe specialize in AI-enabled camera modules, precision optics spanning UV to LWIR, and custom embedded imaging systems powering applications in robotics, autonomous vehicles, submersible imaging, biomedical instrumentation, AR/VR, and optical computing. We are seeking a Manager of Engineering (up to Director for the right candidate) to lead our multidisciplinary mechanical, electrical, and optical engineering teams, reporting directly to the CEO & CTO.
Engineering Intern AtriCureEngineering InternPleasanton, CaliforniaSupport pilot build activities including production associate training, component and assembly flow, root cause analysis and inspection data organization/collection. POSITION SUMMARY: The Co-Op/Intern is an undergrad or master’s student pursing an engineering degree and is interested in gaining experience in engineering, manufacturing, assembly techniques, process development, and design principles and philosophies.
Senior Systems Engineer DeepSight TechnologySenior Systems EngineerSanta Clara, CAFull timeYour focus will include system engineering principles to ensure successful product V&V, which includes test system requirement generation, verification planning, test architecture development, and integration efforts, working across hardware, software, clinical, quality, and regulatory teams. We offer a collaborative, team-oriented environment along with competitive compensation and generous benefitsDeepSight Technology is seeking a Senior Systems Engineer with a strong focus on Test Development and System Integration to support the development of our next-generation medical imaging platforms.
Staff NPI Engineer - Shockwave Medical Johnson & JohnsonStaff NPI Engineer - Shockwave MedicalSanta Clara, CaliforniaThe Staff NPI Engineer will serve as a subject matter expert for the process development team, provide oversight to pilot manufacturing/testing, and guide products as they transition from development into full production. The Staff NPI Engineer will develop, validate, and implement various processes by working closely with R\&D, Operations, Regulatory, and Quality teams to support the company’s manufacturing operations and product launch timelines.
Laser Field Service Engineer LaserAwayLaser Field Service EngineerSan Jose, CA$90,000–$95,000 / yearEmployees must be able to perform the essential functions of the position satisfactorily and, if requested, reasonable accommodations will be made to enable employees with disabilities to perform the essential functions of their job, absent undue hardship. A LaserAway Laser Field Service Engineer will be responsible for all the laser maintenance, safety, and team communication that ultimately support all clinic operations.
Quality Engineer III Integrated Resources, IncQuality Engineer IIISanta Clara, CA$40–$45 / hourDevelop, maintain, and approve SOPs, work instructions, templates, and quality records supporting BEA Santa Clara manufacturing, integration, inspection, and release activities in compliance with cGMP, ISO 9001, and applicable ISO 13485 requirements. Partner with Supplier Quality, Procurement, and Engineering to address supplier quality issues impacting BEA Santa Clara builds, including review and disposition of supplier nonconformances and SCARs.
Staff NPI Engineer - Shockwave Medical 6947-SHOCKWAVE MEDICAL Legal EntityStaff NPI Engineer - Shockwave MedicalSanta Clara, CaliforniaThe Staff NPI Engineer will serve as a subject matter expert for the process development team, provide oversight to pilot manufacturing/testing, and guide products as they transition from development into full production. The Staff NPI Engineer will develop, validate, and implement various processes by working closely with R\&D, Operations, Regulatory, and Quality teams to support the company’s manufacturing operations and product launch timelines.
Quality Engineer LancesoftQuality EngineerSanta Clara, CA$45Provide hands-on quality support on the production floor, addressing real-time quality issues related to equipment assembly, wiring, tubing, automation configuration, testing, and documentation. Job Description: Partner with Manufacturing, Manufacturing Engineering, Automation, Project Management, and Supply Chain to ensure quality requirements are met throughout project execution, including build, integration, FAT, and release.
R&D Engineer Katalyst Healthcares & Life SciencesR&D EngineerSan Jose, CABachelor's degree in Mechanical Engineering, Biomedical Engineering, Electrical Engineering, Manufacturing Engineering, Industrial Engineering, or a related engineering discipline. The ideal candidate will collaborate with cross-functional teams to transform concepts into commercially viable products while ensuring compliance with quality, regulatory, and customer requirements.
Human Factors Engineer LancesoftHuman Factors EngineerMilpitas, CA$60Duties: Experienced R&D Engineer_Human Factors to apply human factors and ergonomics expertise to the definition, design, and evaluation of products within the R&D division of Diabetes Care;apply knowledge of human factors principles (human performance and limitations perceptual, cognitive, motor skills, anthropomorphic) and techniques (knowledge acquisition, user-interface design, usability evaluation) to diabetes care systems product development; Deliverables include, but are not limited to: Usability engineering files; Task analyses; Usability risk analyses; Usability testing throughout the product development process, from formative testing of early prototypes through usability validation of final designs. Proven ability to apply user-centered design and human factors/usability engineering principles to product research, development and design;experience in medical device development; Proven ability to quickly assimilate advanced domain knowledge and guide program teams on Human Factors strategy, HF deliverables for program scope, research strategy across the product development lifecycle and successful deliverable completion within project timelines.
Sr Systems Test Engineer SoloPoint Solutions, Inc.Sr Systems Test EngineerPleasanton, CASupport testing using benchtop biologic and ex vivo models; occasional large-animal lab support. Responsibilities Design, build, and validate test fixtures for fluidic, mechanical, and optical systems from concept through completion.
Manufacturing Engineer Karwell TechnologiesManufacturing EngineerPleasanton, CAJob Summary: Manufacturing Engineer with 3 4 years of experience in the medical device manufacturing industry, specializing in supporting regulated production environments. Strong background in cross-functional collaboration with manufacturing and quality teams to improve production efficiency and maintain robust documentation control.
Quality Engineer Karwell TechnologiesQuality EngineerPleasanton, CASummary: We are looking for a Quality Engineer with 0 3 years of experience to support quality systems, validation, CAPA, and compliance activities in a regulated medical device/pharma environment. Basic knowledge of FDA 21 CFR 820, ISO 13485, CAPA, Validation, and Quality Management Systems.
Requirements Tools Engineer LancesoftRequirements Tools EngineerPleasanton, CA$55Working in Pleasanton, CA, this individual will collaborate with cross functional engineering teams to establish scalable structures and best practices that allow engineers to efficiently create and manage requirements and other design control documents in the management tool. This role is focused on administering and configuring enterprise requirements management platforms, supporting data migration activities, and enabling engineering teams through processes, and training.
Quality Engineer Katalyst Healthcares & Life SciencesQuality EngineerPleasanton, CAWe are looking for a Quality Engineer with 0–3 years of experience to support quality systems, validation, CAPA, and compliance activities in a regulated medical device/pharma environment. Basic knowledge of FDA 21 CFR 820, ISO 13485, CAPA, Validation, and Quality Management Systems.
Manufacturing Engineer Katalyst Healthcares & Life SciencesManufacturing EngineerPleasanton, CAStrong background in cross-functional collaboration with manufacturing and quality teams to improve production efficiency and maintain robust documentation control. Manufacturing Engineer with 3–4 years of experience in the medical device manufacturing industry, specializing in supporting regulated production environments.
Quality Engineer I LancesoftQuality Engineer IPleasanton, CA$30This role assists senior engineers with validation activities, quality documentation, and problem solving in a highly regulated environment governed by FDA 21 CFR 820, ISO 13485, and ISO 14971. Key Responsibilities Support validation activities Assist in equipment, process, and software validation (including CSV), troubleshoot discrepancies, and help plan validation efforts using risk based approaches.
Staff Quality Engineer, Design Quality - Pleasanton, CA Calyxo IncStaff Quality Engineer, Design Quality - Pleasanton, CAPleasanton, CA$170,000–$185,000 / yearIn This Role, You Will: Ensure design controls for new product development and improvement project activities, including risk management, design V&V, product software validation, design reviews, tagging/tracing, non-product tools validation, test method validation, and design transfer are in compliance with Calyxo Quality System, FDA 21 CFR Part 820, ISO 13485, ISO 14971, IEC 62304, IEC 60601, and relevant global regulations. Drive risk management activities per ISO 14971, including risk management plan, hazard analysis, FMEAs (design, software, user), risk-benefit analysis, and risk management report.
Clinical Research Engineer Noctrix HealthClinical Research EngineerPleasanton, California$130,000–$150,000 / yearBachelor’s degree in Engineering, Biomedical Engineering, Electrical Engineering, Computer Science, or a related technical discipline with 5+ years of relevant industry experience, or a Master’s degree with 3+ years of relevant experience. This role sits at the intersection of engineering and clinical science, contributing to software and firmware development, physiological signal processing, clinical data analysis, device characterization, verification and validation, and clinical research activities.
Senior Failure Analysis Engineer Johnson & JohnsonSenior Failure Analysis EngineerSanta Clara, CaliforniaBusiness Case Modeling, Coaching, Critical Thinking, Design Thinking, Feasibility Studies, Mechanical Engineering, Problem Solving, Process Oriented, Product Design, Product Development, Project Management Methodology (PMM), Project Support, Research and Development, SAP Product Lifecycle Management, Technical Credibility, Technical Writing, Technologically Savvy . This role offers the opportunity to combine hands-on technical investigation with process development, laboratory ownership, and cross-functional leadership to build a scalable Failure Analysis function that supports product reliability and continuous improvement throughout the Ottava lifecycle.