215 medical device engineer jobs at 79 companies in Alameda, 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
Waltham or Zebulon or Marietta or Ware or Upper Providence or Barnard Castle or Cambridge or Rockville or San Francisco
$143k-$238k/yrHybridFull Time
GSKLondon Stock Exchange: GSK: Develops and manufactures innovative vaccines and specialty medicines.
10+ YOEBachelor's in engineering or science with 10+ years in medical device manufacturing, or master's with 5+ years; requires GMP, regulatory, ISO, device lifecycle, risk management, and technology transfer expertise.
FDA 21 CFR 820, EU MDR, ISO 13485, ISO 14971, ISO 10993, GMP, ICH Guidelines, FDA QSR, DHF, Technical File, Microsoft Excel
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
BioMarin PharmaceuticalNASDAQ: BMRN: Biotechnology developing therapies for rare genetic diseases.
8+ YOERequires 8+ years developing and commercializing parenteral combination products and medical devices, cross-functional team leadership, design controls, contract manufacturing, regulatory compliance, and a bachelor's degree in engineering or life sciences.
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.
Johnson & JohnsonNYSE: JNJ: Develops and manufactures pharmaceutical drugs and medical devices.
5+ YOEBachelor's in Mechanical or Biomedical Engineering, 5+ years medical device experience, knowledge of QSR/FDA/ISO, Lean/Six Sigma, device validation (IQ-OQ-PQ), SolidWorks, ERP/MES (Oracle), cleanroom experience, able to lift ~25lbs.
SolidWorks, ERP, MES, Oracle, SAP Product Lifecycle Management
Johnson & JohnsonNYSE: JNJ: Provides pharmaceutical products and medical technology healthcare solutions.
5+ YOEBachelor's in Mechanical or Biomedical Engineering,5+ years medical device experience,knowledge of QSR/FDA/ISO/MDR,Lean/Six Sigma,device validation (IQ-OQ-PQ),SolidWorks,ERP/MES experience,ability to work in Class 8 cleanroom.
SolidWorks, ERP, MES, Oracle, SAP Product Lifecycle Management
ZOLL Medical: Manufactures medical devices and software for emergency care.
15+ YOE7+ MgmtAdvanced engineering degree, 15+ years developing electronic hardware and embedded software for real-time medical instruments, 10+ years as systems engineer, 7+ years leading systems engineering, FDA/EC experience.
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
SI-BONENASDAQ: SIBN: Develops minimally invasive surgical systems for sacropelvic joint fusion.
2+ YOEBachelor's in Manufacturing or Mechanical Engineering; 2+ years in manufacturing engineering, in medical devices; CAD/SolidWorks/ERP experience; packaging/labeling knowledge; able to work with suppliers and QA/RA.
CAD, SolidWorks, Minitab, Microsoft Excel, Microsoft Access, Microsoft Project, ERP systems (QAD), Label software
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.
Cordis: Developer of interventional cardiovascular and endovascular medical devices.
5+ YOEEngineering Bachelor’s degree with 5+ years in medical device R&D; experience in cardiovascular devices, complex projects, and driving technical excellence.
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.