47 medical device engineer jobs at 24 companies in Burke, VA
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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
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Device Assembly Process Engineer
Gaithersburg, Maryland, United States
$79k-$119k/yr OnsiteFull Time
5+ YOERequires a Mechanical Engineering, Biomedical Engineering, related engineering, or pharmaceutical science degree and 5+ years' experience with a bachelor's or 2+ years' experience with a master's, plus medical device or combination product expertise.
QbD
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Device Assembly Process Engineer
Gaithersburg, Maryland, United States
$79k-$119k/yr OnsiteFull Time
5+ YOEBachelor's degree with 5+ years or master's degree with 2+ years in medical device or combination product experience; expertise in assembly processes, GMP, validation, experimental design, and technical writing.
QbD, cGMP, GMP
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Device Assembly Process Engineer
Gaithersburg, Maryland, United States
$79k-$119k/yr OnsiteFull Time
5+ YOEBachelor's degree with 5+ years or master's degree with 2+ years in medical device or combination product experience; expertise in assembly processes, GMP, validation, QbD, experimental design, statistics, and technical writing.
QbD, GMP
2w
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Medical Device Regulatory Specialist
Washington, D.C., District of Columbia, United States
$144k-$208k/yr OnsiteFull Time
5+ YOEMaster's degree in engineering or related technical field, 5 years in regulatory affairs, medical device and SaMD standards experience, and expertise monitoring regulations and writing policy documents.
Software as a Medical Device (SaMD), Cloud-native Quality Management Systems, ISO 13485, ISO 42001, IMDRF, ISO/IEC, AAMI
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Associate Director, Device Lead
Waltham or Zebulon or Marietta or Ware or Upper Providence or Barnard Castle or Cambridge or Rockville or San Francisco
$143k-$238k/yr HybridFull Time
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
3w
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Field Service Engineer (Medical Device) (Baltimore, MD based Field role)
Baltimore, Maryland, United States
$37-$63/hr FieldFull Time
2+ YOEBachelor's degree in engineering or related field, 2–5 years of technical field service experience, strong troubleshooting, communication, technical writing, and willingness to travel up to 75%.
Salesforce (SFDC)
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Biomedical / Clinical Engineer V – DoD Medical Systems
Fort Detrick, Maryland, United States
$105k-$120k/yr HybridFull Time
3+ YOEBachelor's engineering degree from an ABET-accredited program or CCE credential, 3+ years of HTM and clinical engineering experience, US citizenship, NACI eligibility, and medical-device lifecycle expertise.
CT, X-ray, HVAC, IT, JMAR, Joint Medical Asset Repository, DMLSS, Defense Medical Logistics Standard Support, DML-ES, Defense Medical Logistics Enterprise Solution
3w
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Process Engineer II - Equipment Engineering
Frederick, Maryland, United States
$100k-$129k/yr OnsiteFull Time
3+ YOEBachelor's degree in engineering and 3–5 years of engineering experience in biotechnology, pharmaceuticals, medical devices, or a related regulated industry. GMP familiarity and equipment experience preferred.
Enterprise Asset Management System
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Staff Engineer
Allendale or Leesburg
$128k-$136k/yr OnsiteFull Time
4+ YOEBachelors in Mechanical/Biomedical Engineering required (Master's preferred), 4+ years medical device product development experience, proficiency with parametric CAD (Creo or SolidWorks), GD&T, experience with design controls and regulated industry standards (FDA, ISO 13485).
Creo, SolidWorks, GD&T
4d
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Embedded Systems Engineer (Medical Devices)
Ashburn or Bethesda
OnsiteFull Time
4+ YOERequires 4–7+ years of embedded systems experience, FPGA schematic and board design, Xilinx Vivado/Vitis, AXI, VHDL/Verilog/SystemVerilog, embedded Linux, C/C++ or Rust, Python, and communication protocols.
Xilinx FPGAs, AXI, Vivado, Vitis, AXI4, Linux, C++, Rust, Python, IEC 62304, ISO 13485, FMEA, oscilloscopes, logic analyzers, Altium Designer, KiCad, VHDL, Verilog, SystemVerilog, Yocto, PetaLinux, Buildroot, SPI, I2C, UART, Digital Signal Processing (DSP), Zynq, MPSoC, RFSoC, FDA, MDR, ADCs, DACs, PMICs
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Sr. Mechanical Engineer
Germantown, Maryland, United States
$115k-$150k/yr OnsiteFull Time
8+ YOEBachelor's in mechanical engineering, 8+ years product development experience in medical devices, injection-molded component and tooling expertise, mold qualification (IQ/OQ/PQ), SolidWorks proficiency, and strong written/verbal communication.
SolidWorks
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CQV Engineer, General Application
Blue Bell or Somerset or Cary or Burlington or Houston or Leawood or Emeryville or Irvine or Germantown or Elkton or Cherry Hill
$67k-$112k/yr FieldFull Time
2+ YOEBachelor of Science in Engineering, 2+ years relevant experience in pharmaceutical/biotech/medical device commissioning/validation/QA, knowledge of cGMP, ability to lift 50 lbs, cleanroom gowning, and travel extensively.
1mo
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Senior / Principal Process Development Engineer
Baltimore, Maryland, United States
OnsiteFull Time
5+ YOEHands-on process development, scale-up, optimization, and validation experience for regulated polymeric/biomaterial or medical device manufacturing; DOE and statistical analysis experience; working knowledge of GMP and ISO 13485; BS/MS in engineering or related field.
3mo
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Cardiac Catheter Development Engineer
Bethesda, Maryland, United States
$98k-$163k/yr OnsiteFull Time
4+ YOEBachelor’s in biomedical, mechanical, electrical engineering or related field; 4+ years medical device development with 2+ years cardiac catheter hands-on manufacturing/prototyping; CAD (SolidWorks) proficiency;ISO 10555, IEC 60601-1 knowledge; ability to obtain public trust.
SolidWorks
1mo
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Senior Packaging Engineer I
Columbia, Maryland, United States
$82k-$113k/yr OnsiteFull Time
8+ YOEDesign, develop, validate, and improve packaging systems for sterile and non-sterile medical devices; apply QSR/GMP/design controls, risk management, and statistical methods; 3–8+ years experience depending on degree.
Microsoft Outlook, Microsoft Project, Microsoft PowerPoint, Microsoft Word, Microsoft Excel
2mo
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Computer Engineer - Firmware/Software (Full-Time & Intern Positions)
Baltimore, Maryland, United States
$90k-$105k/yr OnsiteFull Time, Internship
0+ YOEOpen to interns and full-time applicants with 0–5 years experience; developing embedded algorithms, designing embedded architectures, and testing code for medical devices.
1w
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Senior Quality Engineer
Sterling, Virginia, United States
OnsiteFull Time
5+ YOERequires a bachelor's degree in engineering or equivalent, 5–7 years of quality engineering experience, medical device experience preferred, and hands-on CAPA experience. CQE certification preferred.
CAPA, ISO 13485, GMP, GDP, 21 CFR 820, FMEA, SPC
2mo
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Digital Pathology Field Service Engineer
New York City or Memphis or Jacksonville or Washington or Tennessee or Maryland or Virginia or Florida or United States
$75k/yr FieldFull Time
2+ YOEHS diploma, 2+ years field service experience in medical devices/lab automation preferred; proficiency with PC hardware, Windows, Microsoft Office, TCP/IP/VPN; valid driver\u000fs license, ability to lift 50 lbs, willingness to travel up to 50%.
Windows, Microsoft Office, PC hardware, TCP/IP, VPN, CRM, laboratory information systems (LIS)
3d
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VP, Neurology Regulatory Affairs
Washington, District of Columbia, United States
$160k-$445k/yr OnsiteFull Time
15+ YOEBachelor's degree in a scientific, engineering, or regulatory discipline required; MS or PhD preferred. Requires neurology medical device experience, 15+ years in regulatory affairs, and project or managerial experience.
510(k), IDE, PMA, IND, BLA, Technical Documentation, STED, CERs, FDA, Notified Body, ISO 13485
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