282 medical device engineer jobs at 94 companies in Sharon, MA
4d
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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
3mo
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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
2w
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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
3w
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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)
1mo
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Engineer III, Device Development
Boston, Massachusetts, United States
$102k-$133k/yr OnsiteFull Time
3+ YOEHuman factors engineer for medical device and combination product development; experience with design control, formative/summative HF studies, vendor management, and regulatory HF requirements.
1mo
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Engineer III, Device Development
Boston, Massachusetts, United States
$102k-$133k/yr OnsiteFull Time
Experience in human factors engineering for medical devices/combination products, design control, vendor management, and regulatory compliance (IEC 62366, FDA, MDR). Strong written and verbal communication.
1mo
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Engineer III, Device Development
Boston, Massachusetts, United States
$102k-$133k/yr OnsiteFull Time
3+ YOEExperience in human factors engineering for medical devices/combination products, design control, regulatory knowledge (IEC 62366, FDA, MDR), vendor management, study protocol and reporting; Bachelor\u0000s/Master\u0000s plus 3+ years preferred.
1mo
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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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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
1w
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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
5d
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Packaging/Medical Device Quality Engineer
Waltham, Massachusetts, United States
$115k-$136k/yr OnsiteFull Time
5+ YOEBachelor’s degree in engineering or life sciences; 5+ years in medical devices, combination products, packaging, quality, or manufacturing; 2+ years in medical device R&D quality and design controls; knowledge of FDA, EU MDR, ISO 13485, and ISO 14971.
21 CFR Part 4, 21 CFR 820, ISO 13485, ISO 14971, EU MDR, FMEA
1w
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Associate Director, Device Engineering
Waltham, Massachusetts, United States
$159k-$195k/yr HybridFull Time
10+ YOE3+ Mgmt10+ years in medical device or combination product development, including 3+ years leading teams; autoinjector, syringe, or multidose pen launch experience; bachelor's degree in engineering required.
FDA, ISO 13485, ISO 14971, FMEA, IEC 62366, ISO 11608-1, ISO 11040, ASTM D4169, 21 CFR Part 4, IND, IMPD, NDA, BLA
1w
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Manager, Device Development & Manufacturing
Waltham, Massachusetts, United States
$118k-$145k/yr HybridFull Time
6+ YOERequires 6+ years in process or product engineering within medical device, packaging, or pharmaceutical manufacturing; bachelor's degree in a related technical field; combination-product expertise; and knowledge of regulatory standards.
Microsoft Word, Microsoft PowerPoint, Microsoft Excel, Microsoft Outlook, Microsoft SharePoint
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).
1mo
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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
3mo
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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
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.
1w
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Process Engineer
North Attleboro or Atlanta
$120k-$150k/yr OnsiteFull Time
7+ YOEBachelor's degree in a relevant engineering discipline and 7+ years in injection molding, mold engineering, or medical device manufacturing; expertise in scientific molding, validation, polymers, and medical device regulations.
Moldflow, SolidWorks Plastics, FDA, ISO 13485, RJG, Paulson, PEEK, TPU, PC, Nylon
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