37 medical device engineer jobs at 20 companies in Erwin, NC
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Device Engineer
Zebulon, North Carolina, United States
HybridFull Time
3+ YOE3+ years device or medical product experience, hands-on CAD and prototype testing, bachelor’s in a related technical discipline, experience with design controls, risk management and quality processes.
CAD, finite element analysis, in-silico modelling, 3D printing
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.
1d
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Senior Electrical Engineer
Raleigh, North Carolina, United States
OnsiteFull Time
5+ YOEBachelor's degree in electrical or systems engineering, 5+ years in medical devices or regulated environments, 7+ years with mixed-signal FPGA designs, and experience with IEC 62304 and medical-device standards.
C, C++, Verilog, VHDL, FPGA, Altium Designer, OrCAD, Cadence Allegro, PADs, MATLAB, HyperLynx, IEC 60601, IEC 62304, ISO 14971
4w
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Senior Design Quality Engineer - Medical Devices
Carlsbad or Chicago or Raleigh or Durham or Greensboro or Pittsboro
$100k-$140k/yr HybridFull Time
5+ YOEBachelor's degree,5+ years relevant experience,knowledge of FDA 21 CFR 820/ISO 13485/ISO 14971,cGMP,GxP; experience with electromechanical devices, audits, risk management, and verification/validation.
2w
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Engineer 2, Sustaining, R&D
Morrisville, North Carolina, United States
OnsiteFull Time
3+ YOEBachelor's degree in engineering and 3–5 years developing medical devices required. Requires Microsoft Office Suite, engineering principles, medical device regulations, and fluent English; SolidWorks and validation experience preferred.
SolidWorks, Microsoft Project, Microsoft Word, Microsoft Excel, Oracle Agile, SAP, Oracle, PLM, ERP, CADD, ISO, ASTM
2w
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Contract Senior Mechanical Engineer
Morrisville, North Carolina, United States
OnsiteContract
8+ YOEB.S. or M.S. in Mechanical/Biomedical Engineering,8+ years industry experience in wearable/medical device design, Solidworks proficiency, knowledge of medical device standards (IEC 60601, ISO 10993, ISO 13485, ISO 14971, IEC 62366), prototyping and DFM/DFA/DFT experience.
Solidworks
2w
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Sr. Validation Engineer
Raleigh, North Carolina, United States
OnsiteFull Time
7+ YOE7–11 years in biotech/pharma/medical devices, Bachelor's in life science or engineering, strong cGMP and CSV experience, expertise with IQ/OQ/PQ and validation documentation, audit support and technical leadership.
Computerized System Validation (CSV)
2mo
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Patient Specific Automation Engineer
Durham, North Carolina, United States
HybridFull Time
Requires Python and Git proficiency, BS in an engineering discipline, strong analytical and troubleshooting skills, CAD familiarity preferred, and ability to work cross-functionally in a regulated medical device environment.
Python, Git, 3-matic, SolidWorks, Pro/E, Fusion 360, Rhino
2w
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Engineer 1, Design Development, R&D
Morrisville, North Carolina, United States
OnsiteFull Time
1+ YOEBachelor's in engineering, SolidWorks and Microsoft Office proficiency, 1+ year medical device or related research experience preferred, knowledge of molding/extrusion and FDA/ISO design controls preferred.
SolidWorks, Microsoft Project, Microsoft Word, Microsoft Excel, Microsoft PowerPoint
1mo
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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.
3w
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Electrical Engineer 3 - Durham, North Carolina
Durham, North Carolina, United States
OnsiteFull Time
7+ YOEBachelor's in electrical engineering, 7+ years electrical design experience (medical device/regulatory environment preferred), PCB/schematic and embedded systems proficiency, test and troubleshooting skills.
Altium Designer, OrCAD, Eagle, microcontrollers, FPGAs, SPI, I2C, UART, Ethernet, USB, oscilloscopes, multimeters, spectrum analyzers
2mo
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Senior/Principal Engineer or Scientist, Combination Products
Bern or Munich or Switzerland or Research Triangle Park or Boston or Chicago or Philadelphia or New Jersey
HybridFull Time
8+ YOEMinimum 8+ years in medical device, pharmaceutical, or combination product industries, bachelor's in engineering or science required, subject matter expertise in combination products, technical leadership and client-facing experience.
2mo
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Operations Quality Engineer
Clayton, North Carolina, United States
OnsiteFull Time
3+ YOEBachelor’s in engineering; 3-5 years in quality or manufacturing quality in a regulated industry; medical device experience preferred; knowledge of FDA 21 CFR Part 820 and ISO 13485; experience with NCMR, CAPA, complaint handling, NPI/product transfer; lean/CI a plus.
Quality Management System (QMS), CAPA, NCMR, NPI, Statistical analysis
2mo
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Senior Software Engineer - hybrid
Morrisville, North Carolina, United States
HybridFull Time
6+ YOE6+ years software development; strong C#/.NET; distributed systems; REST/HL7; SQL Server; unit testing; cloud and containers; familiarity with medical device standards IEC 62304/ISO 13485.
C#, DotNet, REST APIs, HL7, SQL Server, Entity Framework, RabbitMQ, Docker, Kubernetes, Helm, Azure
23h
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Associate Director, Packaging Equipment Technology Engineering
West Point or Durham or Rahway or North Wales or Wilson or Lower Gwynedd Township
$129k-$203k/yr HybridFull Time
10+ YOE3+ MgmtBachelor's degree in packaging or engineering and 10+ years in pharmaceutical, biotechnology, or medical device industries, including 3+ years of leadership; expertise in packaging equipment, GMP, validation, quality systems, and project management.
AutoCAD, SolidWorks, Lean Manufacturing, Six Sigma, Lean Six Sigma (LSS), GMP, Microsoft Excel
3w
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Project Manager – Advanced Tissue Models
Durham, North Carolina, United States
$122k-$206k/yr OnsiteFull Time
5+ YOE5+ years project management experience in new product development for medical devices, experience with Design Controls, BS required (MS preferred), PMP preferred, ability to lead cross-functional teams and travel up to 10%.
1mo
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Maintenance Supervisor - 2nd Shift
Raleigh, North Carolina, United States
OnsiteFull Time
5+ YOEEngineering or technical degree (or equivalent experience),5+ years maintenance experience in regulated pharma/biotech/medical device,knowledge of GMP/FDA/ISO,CMMS (Maximo),DCS and PLC troubleshooting.
Maximo, Foxboro I/A System, Allen-Bradley
1mo
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Project Superintendent
Raleigh, North Carolina, United States
FieldFull Time
5+ YOEMinimum 5+ years as assistant superintendent/field project engineer or equivalent in design/build or construction management for life sciences/medical device projects; ability to manage safety, schedule, quality, and subcontractors.
Bluebeam, Microsoft Office Suite, Sage/Timberline, Procore
3mo
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Maintenance Supervisor - 2nd Shift (Raleigh, US)
Raleigh, North Carolina, United States
OnsiteFull Time
5+ YOE5+ years maintenance experience in regulated pharma/medical device environments; GMP/FDA/ISO knowledge; CMMS (Maximo) experience; engineering degree; strong communication; able to manage multiple priorities.
CMMS (Maximo), Distributed Control Systems, Foxboro I/A System, PLC (Allen-Bradley)
1mo
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Technical Specialist - Embedded Qt Software Architect (Relocation Assistance)
Raleigh or Round Lake
$168k-$231k/yr HybridFull Time
10+ YOEBachelor's or Master's in CS/Software Engineering, 10+ years software development with embedded systems and Qt Studio, Jenkins CI/CD and Git experience, strong knowledge of medical-device regulatory standards and software documentation.
Qt Studio, Qt Widgets, Qt Squish, C/C++, Git, Jenkins
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