16 medical device manager engineering jobs at 8 companies in Washington, DC
1d
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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
2w
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Associate Manager, R&D
Leesburg or Allendale
$125k-$135k/yr HybridFull Time
6+ YOEB.S. in Mechanical/Biomedical Engineering (Master's preferred) and 6+ years medical device R&D experience; supervisory experience, regulatory (FDA/EU/ROW), design controls, risk management, and CAD experience required.
Creo, SolidWorks
1w
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Deputy Office Director (Supervisory Biomedical Engineer)
Silver Spring, Maryland, United States
$195k-$280k/yr OnsiteFull Time
4+ YOEEngineering degree or qualifying engineering education, registration, examination, or experience, plus 4–11 years of scientific and technical leadership in clinical evidence, regulatory science, engineering, and medical device programs.
USAJOBS, Login.gov, Application Manager, USA Staffing
2w
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Development Engineer
Leesburg or Allendale
$85k-$95k/yr OnsiteFull Time
1+ YOEBS in Mechanical/Biomedical Engineering (MS preferred),1+ year experience (medical device preferred), parametric CAD (Creo or SolidWorks), knowledge of design controls/risk management, ability to support testing and documentation.
Creo, SolidWorks
1mo
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Clinical Engineer
Washington, District of Columbia, United States
$82k-$137k/yr OnsiteFull Time
20+ YOEManage medical equipment selection, installation, maintenance, device integration, safety/recall management, IT security assessments, project leadership, and clinician training.
2w
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Sr. Quality Engineer
Leesburg or Allendale
$95k-$110k/yr OnsiteFull Time
3+ YOEBachelor's in engineering, minimum 3 years quality experience in medical device or regulated manufacturing, knowledge of risk management, CAPA, audits, ISO 13485 and FDA QSR, root cause analysis, supplier control, and statistical process control.
2w
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Associate Manager, R&D
Leesburg or Allendale
$125k-$135k/yr HybridFull Time
6+ YOEB.S. in Mechanical/Biomedical Engineering (Master’s preferred),6+ years medical device R&D experience, supervisory experience preferred, regulatory and sustaining product expertise, CAD experience (Creo/SolidWorks) and strong technical communication.
Creo, SolidWorks
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.
3w
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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
1mo
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Sr. Quality Engineer
Leesburg, Virginia, United States
$100k-$110k/yr OnsiteFull Time
3+ YOEBachelor’s in Engineering, 3+ years quality engineering in medical device or regulated manufacturing, knowledge of risk management, CAPA, audits, ISO 13485/FDA QSR/EU MDR, supplier control, and ERP systems.
ERP
2mo
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Quality Engineer II - Design & Reliability Assurance
Princeton or Plainsboro or Braintree or Chicago or Columbia
$71k-$98k/yr OnsiteFull Time
4+ YOEBachelors in science/engineering, 4+ years quality/process/R&D engineering for medical devices, risk management and design control expertise, statistical sampling/analysis experience, MS Office and statistical software proficiency.
Microsoft Office Suite, Minitab, TrackWise, Agile
2w
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Sr. Quality Engineer
Allendale or Leesburg
$95k-$110k/yr OnsiteFull Time
3+ YOEBachelor's degree in engineering, 3+ years quality experience in medical device or regulated manufacturing, strong knowledge of risk management, CAPA, audits, validation, supplier controls, and regulatory requirements (ISO 13485, FDA QSR).
Measurement System Analysis (MSA)
2mo
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Staff Quality Engineer, Design & Reliability Assurance
Princeton or Plainsboro or Braintree or Chicago or Columbia
$109k-$150k/yr OnsiteFull Time
8+ YOEBachelor's in science/engineering, 8+ years in quality/process/R&D engineering for medical devices (3+ years direct DQA), expertise in risk management and design control, statistical analysis, MS Office and statistical software, FDA/ISO audit experience.
Microsoft Office Suite, TrackWise, Agile product lifecycle management system, statistical software
2mo
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Sr Quality Engineer, Design Assurance
Princeton or Plainsboro or Braintree or Chicago or Columbia
$82k-$113k/yr OnsiteFull Time
4+ YOEBachelor's in science or engineering, 4+ years quality/process/R&D experience in medical devices, expertise in risk management, design controls, statistical analysis, ISO/QSR/GMP, MS Office and Minitab; TrackWise and Agile experience preferred.
Microsoft Office Suite, Minitab, TrackWise, Agile
2mo
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Vice President, MedTech Cardiovascular Regulatory Affairs
Washington, District of Columbia, United States
$169k-$472k/yr OnsiteFull Time
15+ YOE3+ MgmtMinimum 15 years in Regulatory Affairs for medical devices/drugs/biologics; 3-5 years people management; bachelor’s in science/engineering; MS/PhD preferred; regulatory experience with FDA/Notified Bodies and submissions.
MS Office, Regulatory Submissions tools
3w
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Regulatory Affairs Specialist
Owings Mills, Maryland, United States
OnsiteFull Time
3+ YOE3+ years medical device regulatory experience preparing EU MDR technical documentation, CERs, PMS/PMCF, and international submissions; bachelor\u0002s degree in life sciences/engineering/regulatory affairs; strong regulatory writing and project management.
Microsoft Excel, Microsoft Outlook, Microsoft PowerPoint, Microsoft Word, Microsoft Teams
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