96 medical device engineer jobs at 52 companies in Vallejo, CA
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Senior Device Quality Engineer
San Francisco or California
$160k-$180k/yrHybridFull Time
HeartFlowNASDAQ: HTFL: Provides AI-driven non-invasive cardiac diagnostic software and analysis.
5+ YOEBachelor’s degree in a technical field and 5–8 years of medical device quality engineering or product development experience; strong critical thinking, communication, documentation, and time management skills.
IEC 62304, IEC 82304, ISO 14971, ISO 13485, AAMI TIR45, ISO 81001-5-1, Software as a Medical Device (SaMD), AI/ML, Cloud Infrastructure (SaaS), Design History File (DHF), FDA, MDSAP, FDA 510k, De Novo, PMDA, EU-MDR
Spirair: Develops bioabsorbable implants for minimally invasive nasal procedures.
2+ YOEBachelor's in engineering (preferred), 2+ years R&D experience, SolidWorks proficiency, strong documentation and multitasking skills, and ability to support design control and verification testing.
SolidWorks, Microsoft Word, Microsoft Excel, Microsoft PowerPoint
Hands-on experience designing, prototyping, and testing electromechanical and fluidic medical hardware; strong systems debugging and root-cause analysis; experience with wearable, implantable, or regulated medical devices preferred.
Mizuho OSI: Designs and manufactures specialty surgical tables and positioning systems.
5+ YOEBachelor's in engineering (5+ years) or advanced degree with relevant experience; strong systems engineering, analytical, and testing skills; experience with design history files, verification/validation, and Office/MATLAB/LabVIEW tools.
MATLAB, LabVIEW, EA, Microsoft Outlook, Microsoft Excel, Microsoft Word, Microsoft PowerPoint, Microsoft Visio, Microsoft Project
BioMarinNASDAQ: BMRN: Develops and commercializes therapies for rare genetic diseases.
8+ YOEMinimum 8 years in development and commercialization of parenteral combination products and medical devices; expertise with prefilled syringes, autoinjectors, design controls, human factors, regulatory and contract manufacturing; bachelor's in engineering or life sciences required; advanced degree preferred.
AbbottNYSE: ABT: Manufactures medical devices, diagnostics, and nutritional health products.
5+ YOEBachelor's in Electrical or Biomedical Engineering,5+ years engineering experience in design/testing/manufacturing,experience with electro-mechanical designs,RF antenna work,automation and data analysis,knowledge of FDA/ISO quality and regulatory requirements.
PenumbraNYSE: PEN: Designs and manufactures medical devices for vascular conditions.
2+ YOEAssociate's or Bachelor's in engineering or life science,2+ years quality engineering experience (medical device preferred),familiarity with QSR/ISO,experience with electronic devices/PCBAs,proficiency with Microsoft Word/Excel/PowerPoint.
QSR, ISO, PCBAs, Microsoft Word, Microsoft Excel, Microsoft PowerPoint
Verily: Developing data-driven technologies for clinical research and precision health.
5+ YOE5+ years software quality engineering in regulated medical device/SaMD, medical device cybersecurity expertise, knowledge of IEC/ISO standards, experience with risk management and secure SDLC, proficiency with Jira/GitHub/Google Workspace.
Google Workspace, Jira, GitHub, Gemini, Claude, ChatGPT
Calyxo: Develops vacuum-assisted devices for minimally invasive kidney stone removal
12+ YOE12+ years medical device experience with system architecture ownership; BS in engineering required (MS/PhD preferred); proficiency with Jama, dFMEAs, requirements traceability, and medical device standards; strong systems thinking and leadership.
AbbottNYSE: ABT: Provides medical devices, diagnostics, and science-based nutritional products.
10+ YOEBachelor's in mechanical engineering (Master's preferred), 10+ years engineering experience, strong mechanical design and medical device development knowledge, regulatory familiarity, and excellent communication skills.
Sciton: A developer of laser and energy systems for aesthetic and medical applications focused on innovation and product excellence.
10+ YOEBSEE required,10+ years electrical engineering experience with power electronics, embedded ARM systems, PCB design, and medical device development.
ReCor Medical: Develops ultrasound-based renal denervation systems to treat hypertension.
5+ YOEB.S. in engineering, 5+ years in a regulated medical device environment, 5 years packaging/labeling experience, ERP and electronic label/UDI tool proficiency, SolidWorks, JMP/MiniTab, disposable device and sterile packaging experience.
Remedy Robotics: Building remotely operated robotic systems for endovascular surgery.
5+ YOE5+ years of medical device engineering with catheter development; leadership in regulatory clearance; DHF/V&V experience; experience with contract manufacturers; strong FDA/ISO knowledge.
3+ YOEBachelor’s degree in engineering or related field and 3+ years in a related role. Requires root cause analysis, communication, presentation, and continuous improvement experience; medical device and process validation experience preferred.
Quality Management System (QMS), Standard Operating Procedures (SOPs), IQ, OQ, PQ
Shenzhen or Suzhou or Thailand or Malaysia or Emeryville
RemoteFull Time
Eko Health: Develops AI-powered stethoscopes and cardiac disease detection software.
5+ YOEBachelor's degree in a relevant engineering or materials discipline, 5+ years of regulated medical device manufacturing experience, process validation expertise, supplier audit experience, CAD proficiency, and Mandarin and English fluency.
IQ/OQ/PQ, FDA 21 CFR Part 820, ISO 13485, GD&T, pFMEA, SPC, Cpk, Ppk, 510(k), PLM, QMS, SolidWorks
Epia Neuro: A neural technology developing implantable and external systems to restore function and independence for people with neurological conditions.
8+ YOEBachelor's degree in mechanical engineering, 8+ years medical device experience, SolidWorks proficiency, experience with FDA Design Controls and ISO 13485, verification protocols, mechanical testing and fixture development.
Juul Labs: Produces electronic vaporizers and nicotine pods for adult smokers.
8+ YOE8+ years mechanical engineering; experience with medical devices or regulated products; overseas supplier collaboration; Python proficiency; 3D MCAD (SolidWorks) and EC/mechanical integration.
Python, SolidWorks, 3D CAD, FEA, CFD, DFMEA, Design of Experiments
Cytek BiosciencesNASDAQ: CTKB: Manufacturer of spectral flow cytometry instruments and biological reagents.
0+ YOEBS in Science/Engineering/Math, 0–2 years product development/verification experience for medical devices or IVD, writing requirements, multidisciplinary engineering knowledge, flow cytometry familiarity, experience with system engineering tools.
Galvanize Therapeutics: Developer of pulsed electric field energy medical devices.
5+ YOEBachelor's in engineering, 5+ years servicing complex medical devices or capital equipment, knowledge of FDA QSR/ISO 13485/GMP, ESD controls, electro-mechanical troubleshooting, ability to read schematics, and document service work.