2,328 medical device engineer jobs at 587 companies in United States
Medical Device Mechanical Engineer
Bethesda, Maryland, United States
RemoteFull Time
10+ YOEBachelor's degree in mechanical, biomedical, or related engineering; 10+ years of medical device mechanical engineering experience; expertise in testing, durability, fatigue analysis, or FEA; U.S. citizen or full green card holder.
Microsoft Office, Finite Element Analysis (FEA), ASTM F2503, ASTM F2477, ASTM F2606, ASTM F2942, ANSI/AAMI/ISO 14971, 21 CFR Part 820
Co-Op – Medical Device Engineer
Plymouth Meeting, Pennsylvania, United States
OnsiteFull Time, Internship
Enrolled in a Bachelor's or Master's engineering or scientific program; strong organizational, problem-solving, and communication skills; proficiency in Microsoft Excel, Word, PowerPoint; experience with SolidWorks and Instron preferred.
SolidWorks, Microsoft Excel, Microsoft Word, Microsoft PowerPoint, Instron Tensile/Compression machine
Engineer, Device Engineering
Pasadena or San Diego or Verona
$120k-$1550k/yr OnsiteFull Time
8+ YOEBachelor's degree in engineering or pharmaceutical sciences and 8+ years of combination product or medical device development experience, including prefilled syringes, autoinjectors, design controls, human factors, risk management, and regulations.
Design History File (DHF), ISO 14971, ISO 13485, EU MDR, INDs, IMPDs, BLAs, MAAs, cGMP
Packaging/Medical Device Quality Engineer
Waltham, Massachusetts, United States
$115k-$136k/yr OnsiteFull Time
5+ YOEBachelor's degree in engineering, life sciences, or related field; 5+ years in medical device, combination product, packaging, quality, or manufacturing; 2+ years in medical device R&D quality and design controls.
21 CFR Part 4, 21 CFR 820, ISO 13485, ISO 14971, FMEA, Design Controls
Senior Medical Device Systems Engineer
Cambridge, Massachusetts, United States
$110k-$140k/yr HybridFull Time
3+ YOEBachelor's degree in Electrical Engineering, Biomedical Engineering, or related field; 3-5 years hands-on electronics/hardware engineering experience; PCB schematic and layout experience; analog/mixed-signal circuit design fundamentals; supplier management; AI-assisted tool comfort.
Python, GitHub Copilot, Claude, ChatGPT, Cursor
Principal Medical Device Development Engineer (Embedded) IRC307364
Waltham, Massachusetts, United States
$145k-$155k/yr HybridFull Time
10+ YOEBachelor's or Master's in CS, software, computer, electrical, or biomedical engineering; 10-15+ years embedded software development; C/C++, embedded Linux/RTOS, device drivers, debugging tools; medical device regulatory experience (IEC 62304, ISO 13485, FDA).
C, C++, Embedded Linux, RTOS, JTAG, oscilloscope, logic analyzer, protocol analyzer, embedded debugger, UART, SPI, I2C, USB, CAN, Ethernet, CI/CD
Senior Medical Device Quality Engineer
Collegeville, Pennsylvania, United States +1 more
HybridFull Time
5+ YOEBachelor's degree in biomedical, mechanical, electrical, or quality engineering; 5+ years in pharmaceutical/biopharmaceutical with medical device quality oversight; experience with ISO 13485, FDA 21 CFR 820, root cause analysis, CAPA, design controls, and risk management.
ISO 13485, FDA 21 CFR part 820, ISO 14971
Sr Staff Device Engineer
Lexington, Massachusetts, United States
$137k-$215k/yr OnsiteFull Time
3+ YOERequires a technical engineering degree and 3–8+ years of relevant experience, with medical device and drug delivery expertise, design controls, quality systems, combination product lifecycle management, and technical leadership.
DHF, MDR, ISO 13485, ISO 14971, CAPA, cGMP
Sr Device Engineer
West Chester, Pennsylvania, United States +1 more
OnsiteFull Time
2+ YOEBS with 4–6 years or MS with 2–4 years of relevant pharmaceutical, biotech, medical device, or combination product development experience; mechanical systems, materials, hands-on lab testing, and regulated documentation experience.
JMP, Microsoft Excel, Minitab, Instron, Zwick, 21 CFR 820, ISO 13485, Good Documentation Practices (GDP)
VP, Medical Device Engineering
Menlo Park, California, United States
$340k-$380k/yr OnsiteFull Time
15+ YOEBachelor's degree in Mechanical Engineering; 15+ years medical device industry experience with Class II devices; proven R&D leadership; deep knowledge of FDA regulations (21 CFR Part 820) and ISO 13485/14971; successful regulatory clearance and commercialization.
Senior Medical Device Research and Development Engineer
Brooklyn, New York, United States
$100k-$160k/yr OnsiteFull Time
5+ YOEBachelor's degree in a relevant engineering or scientific field, 5+ years of product development experience, 4+ years in cGMP-regulated R&D, medical device experience, and strong leadership and analytical skills.
Microsoft Excel, Microsoft Word, Microsoft PowerPoint, SolidWorks, 21 CFR 820, ISO 9001, ISO 13485:2003, ISO 14971:2007, Good Documentation Practices (GDP), Good Manufacturing Practices (cGMP), Design Verification and Validation (V&V)
Device Engineering Sr. Engineer
Cambridge, Massachusetts, United States
$115k-$156k/yr HybridFull Time
5+ YOEEngineering degree or equivalent experience; 5+ years of mechanical engineering preferred, 3+ years in medical device development preferred, and experience with robustness disciplines, manufacturing, GMP, quality systems, and English communication.
Associate Director, Quality Medical Device Engineer
Hampton, New Jersey, United States
$154k-$200k/yr OnsiteFull Time
10+ YOEBachelor's in engineering or related field required; 10+ years in quality assurance/engineering for combination products; experience with CMOs, injectable devices, and regulatory compliance (FDA, ISO, EU MDR).
Senior Device Development Engineer
Tarrytown, New York, United States
$66k-$144k/yr OnsiteFull Time
5+ YOEBachelor of Science in Biomedical, Mechanical, or Chemical Engineering required; 5+ years product development or engineering experience; medical device industry experience required; experience with Design Control (21 CFR 820 / ISO 13485) and ISO 14971 required.
Senior Device Design Engineer
Little Chesterford or Dublin or Cambridge or Sandwich or Pittsburgh
OnsiteFull Time
Bachelor's or master's degree in product design, mechanical engineering, or related field; proven medical device or combination product development experience; CAD, tolerance analysis, FEA, CFD, ISO 13485, and ISO 14971 expertise.
Computer-Aided Design (CAD), SolidWorks, Creo, Computational Fluid Dynamics (CFD), Finite Element Analysis (FEA), Design History File (DHF), Bill of Materials (BOM), Failure Mode and Effects Analysis (FMEA), Fault Tree Analysis (FTA), Geometric Dimensioning and Tolerancing (GD&T), Quality Management System (QMS)
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