282 medical device engineer jobs at 96 companies in Stoneham, MA
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Device Engineering Sr. Engineer
Cambridge, Massachusetts, United States
$115k-$156k/yr HybridFull Time
Doctorate/Master with 2+ yrs or Bachelor with 4+ yrs in engineering; experience in medical devices; design for robustness; cross-disciplinary work; English fluency.
Injection Molding, DFR Tools, Quality Management Systems
3d
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Sr Staff Device Engineer
Lexington, Massachusetts, United States
$137k-$215k/yr OnsiteFull Time
3+ YOEPhD with 3+ years, master's with 5+ years, or bachelor's with 8+ years in engineering; medical device SME expertise, combination products, design controls, quality systems, manufacturing, regulatory standards, and technical leadership required.
DHF, MDR, ISO 13485, ISO 14971, CAPA, cGMP
1w
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Senior Medical Device Compliance Engineer
Needham, Massachusetts, United States
$88k-$150k/yr OnsiteFull Time
5+ YOEBachelor’s degree required and 5+ years in medical device design controls and post-market sustaining; expertise in ISO 14971, risk management, DFMEA, requirements, V&V, ECNs, and audits.
ISO 14971, DFMEA, Electronic Change Notice (ECN)
2w
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Senior Medical Device Software Engineer
Newton, Massachusetts, United States
OnsiteFull Time
2+ YOE2+ years production software engineering; experience in robotics, computer vision/ML, or systems/infrastructure; comfortable with Python,C++,Linux,GIT; ability to work in high-reliability regulated environments.
Python, C++, Linux, GIT, CI/CD, Drake, ROS, Moveit, RVIZ, Gazebo, Isaac Sim, QNX
3w
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Associate Director, Device Engineering
Waltham, Massachusetts, United States
$159k-$195k/yr HybridFull Time
10+ YOE3+ Mgmt10+ years medical device or combination product development experience with 3+ years leadership; expertise in autoinjectors/prefilled syringes/multidose pens, design controls, risk management, verification/validation, human factors, and regulatory submissions.
1w
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Quality Engineer II - Medical Device #5453
Taunton, Massachusetts, United States
OnsiteFull Time, Contract
3+ YOEBachelor's in engineering, 3+ years R&D medical device experience, knowledge of FDA QSR and ISO standards, SPC/DOE/FMEA/CAPA experience, strong communication and technical writing.
SPC, DOE, ANOVA, GR&R, FMEA, CAPA, IQ, OQ/PQ, FDA 21CFR820, ISO 13485, ISO 14971, ISO 11607
2mo
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Senior Device Quality Engineering Lead
Cambridge or Research Triangle Park
$138k-$185k/yr HybridFull Time
7+ YOEBS in engineering or related discipline, 7+ years in medical device/combination product quality with design control and risk management expertise, regulatory knowledge, and cross-functional leadership experience.
3mo
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Device Quality Engineer - Device Risk Management and Surveillance Excellence
Cambridge, Massachusetts, United States
$90k-$130k/yr OnsiteFull Time
5+ YOEBS in Engineering or related science; MS desired; 5+ years medical device experience; 3+ years risk management and post-market surveillance; ISO 14971, MDR, and 21 CFR 820 knowledge; English required; French or German a plus.
ISO 14971, Post-Market Surveillance, FMEA, Regulatory Compliance (MDR / 21 CFR 820), Design Controls, DHF Management
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Senior Medical Device Software Engineer (Python / C++)
Boston or United States
HybridFull Time
4+ YOEBachelor’s degree in CS/CE/EE (or higher) with relevant experience; deep Python and C++ expertise, embedded/real-time software, ROS, Linux, Bluetooth, CI/CD and Git experience; strong communication and problem-solving.
C++, Python, ROS, Linux, Git, CI/CD, AWS, Azure, Bluetooth
1mo
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Staff Design Control Engineer, Design Quality (IVD/CDx/Medical Device))
Marlborough, Massachusetts, United States
$105k-$125k/yr HybridFull Time
8+ YOE8+ years in design or quality engineering for medical device/IVD; deep knowledge of design controls, risk management, V&V, design transfer; Bachelor's degree required; strong regulatory knowledge (FDA QMSR, ISO 13485/14971).
3w
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Product Cybersecurity Engineer (Medical Devices)
Wilmington, Massachusetts, United States
$135k-$202k/yr OnsiteFull Time
7+ YOE7+ years cybersecurity/product security experience supporting FDA-regulated medical devices or SaMD, Master's degree (Ph.D preferred), threat modeling, vulnerability management, and familiarity with FDA guidance and cybersecurity frameworks.
STRIDE, NIST Cybersecurity Framework, ISO 14971, IEC 62304, AAMI TIR57, OWASP, SBOM
1mo
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Program Manager - Medical Device
Beverly or Baldwin Park
$120k-$140k/yr OnsiteFull Time
8+ YOEBachelor's in engineering/chemistry/biology, 8+ years in medical device, 6+ years program/project management in manufacturing, knowledge of ISO/GMP/regulatory (FDA/MDR/Health Canada/PMDA), DOE/Lean/Six Sigma experience.
2mo
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Senior Electromechanical Product Developmen Engineer - Medical Devices
Foxborough, Massachusetts, United States
$100k-$140k/yr OnsiteFull Time
Bachelor's in Mechanical, Electrical or Biomedical Engineering; medical device design experience; SolidWorks; Arduino/prototyping; FDA QSR/ISO knowledge; ability to take products from concept to market.
SolidWorks, Arduino, PCB design, soldering, wiring, software validation
2mo
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Senior Electrical Engineer – Medical Imaging (Bedford, MA)
Bedford, Massachusetts, United States
OnsiteFull Time
5+ YOE5+ years in electrical engineering; medical devices or regulated industries preferred; PCB design (Altium); analog/digital circuits; IEC 60601-1, EMC; Bachelor's or Master's in Electrical Engineering.
Altium Designer, Python, C
3w
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Senior Electrical Engineer, Medical Devices
Pleasanton or Atlanta or Burlington
$90k-$180k/yr OnsiteFull Time
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.
Windchill, MCAD
1mo
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Engineer III, Devices
Mansfield, Massachusetts, United States
$111k-$166k/yr OnsiteFull Time
4+ YOE4+ MgmtBSc in engineering, minimum 4 years medical device experience and 4 years leading projects, knowledge of design control, FDA/ISO requirements, project management, and customer interaction; PMP preferred.
Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Microsoft Project
1w
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Research Engineer
Boston, Massachusetts, United States
$51k-$82k/yr OnsiteFull Time
Mass General Brigham: Provides integrated medical care, research, and clinical training services.
0+ YOEBachelor's degree in a related field; preferred device or medical engineering experience; project management, interdisciplinary teamwork, technical troubleshooting, writing, fabrication, and engineering tool skills.
6d
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Plant Engineer III
Bedford, New Hampshire, United States
OnsiteFull Time
5+ YOEBachelor's degree in engineering and 5+ years of engineering, facilities, clean utilities, or plant utilities experience, preferably in biotechnology, medical device, or pharmaceutical manufacturing.
Computerized Maintenance systems (CMMS), AutoCAD, SolidWorks, PLC, SCADA, Microsoft Word, Microsoft Excel, Microsoft Project, Microsoft PowerPoint
3w
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Senior Quality Engineer, Cybersecurity
Dallas or Boston or San Bruno
$113k-$170k/yr HybridFull Time
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
4d
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Manufacturing Engineer II
Bedford, Massachusetts, United States
$77k-$110k/yr OnsiteFull Time
2+ YOEBachelor's degree in engineering or materials science, 2+ years in medical device engineering, process validation, manufacturing methods, GMP/GDP, statistical analysis, and technical documentation.
QAD, Oracle, SAP, Microsoft Office, Microsoft Excel, SolidWorks, 3D CAD, Enterprise Resource Planning (ERP), Gage R&R, IQ/OQ/PQ, DOE, 21 CFR Part 820, EU MDR
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