2mo
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Medical Device Manufacturing Engineer (Capital Equipment)
Marlborough, Massachusetts, United States
$75k-$99k/yr OnsiteFull Time
3+ YOEBachelor's degree in a technical discipline; 3-5+ years in medical device manufacturing; knowledge of U.S. and global medical device regulations; strong project management; ERP and MS Office proficiency; Russian language preferred.
ERP, Microsoft Office, Test equipment, PCB soldering stations, Soldering tools
1mo
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Process Validation Engineer (Medical Device) #2323
Westborough, Massachusetts, United States
OnsiteContract, Full Time
7+ YOEBachelor's in Engineering, 7+ years medical device process engineering, experience with process validation (IQ/OQ/PQ), DOE, FMEA, CAPA/NCR ownership, FDA/ISO 13485 knowledge, strong analytical and communication skills.
2w
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GRA Device Associate - Medical Devices and Combination Products (Senior Manager)
Morristown or Cambridge or Framingham
$122k-$177k/yr HybridFull Time
6+ YOEBachelor's in science/engineering required (advanced degree preferred); 6+ years industry experience, 3+ years regulatory experience; experience with regulatory filings and health authority interactions; strong communication and leadership skills.
2w
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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).
2mo
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Manufacturing Engineer
Mansfield, Massachusetts, United States
$90k-$120k/yr OnsiteFull Time
5+ YOE5+ years medical device manufacturing experience; BS in Mechanical Engineering or Mechanical Engineering Technology; 3-D solid modeling (SolidWorks/AutoCAD/ProEngineer); Microsoft Office; knowledge of FDA GMP, QSR and ISO 13485.
SolidWorks, AutoCAD, ProEngineer, Microsoft Office
1mo
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Senior Quality Engineer
Norwood, Massachusetts, United States
$110k-$130k/yr HybridFull Time
7+ YOEBachelor's in engineering/technical sciences, 7+ years medical device/IVD quality engineering experience, knowledge of ISO/FDA regulations, validation and auditing experience, MS Office and statistical software proficiency.
Microsoft Word, Microsoft Excel, Microsoft Access, Minitab, MasterControl, Power BI
1mo
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Lead Systems Engineer
Marlborough, Massachusetts, United States
$119k-$187k/yr OnsiteFull Time
8+ YOELead Systems Engineer with 8+ years experience; Bachelor's in engineering; MBSE, MATLAB/Simulink, design controls for medical devices; strong communication and cross-functional collaboration.
MATLAB, Simulink, MBSE, ALM, Python
5d
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Sr Mechanical Engineer
Minneapolis or Providence
$94k-$122k/yr HybridFull Time
4+ YOEBachelor's in Mechanical Engineering, 4+ years medical device experience, strong CAD and prototyping skills, familiarity with FDA/QSR/ISO, excellent communication and problem-solving.
3D CAD, 2D CAD
3mo
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Validation Engineer III
Boston or Boxborough
OnsiteFull Time
5+ YOEFive+ years in validation/engineering in regulated env; cGMP/pharma/biotech/medical device exp; SME in validation disciplines; strong writing and project management; proficient with GMP utilities and equipment.
4w
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Senior Software Systems Engineer
Marlborough, Massachusetts, United States
$111k-$150k/yr HybridFull Time
4+ YOEBS/MS in engineering or CS, 4+ years software engineering experience, embedded/connected device experience, systems-level debugging, cross-layer software expertise, authorized to work in the U.S.
Bluetooth Low Energy (BLE), IoT, iOS, Android, Flutter, Git, CI/CD, C/C++, APIs
1d
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Design and Sustaining Quality Engineer
Clinton, Massachusetts, United States
$110k-$198k/yr OnsiteFull Time
8+ YOEBachelor's in engineering or equivalent,8+ years quality/new product/process or manufacturing engineering in medical device industry,ISO 13485 and CAPA experience,validation and audit experience,Excel power-user and BI basics.
Microsoft Excel, Microsoft Word, Microsoft PowerPoint, Excel/Sheets, Power BI, Tableau, Looker
2mo
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R&D Engineer - Packaging
Mansfield, Massachusetts, United States
$78k-$117k/yr OnsiteFull Time
2+ YOEBachelor’s degree in Packaging Engineering or Packaging Science; 2+ years in packaging engineering for medical devices or regulated industries; knowledge of FDA, GMP, ISO; CAD tools with SolidWorks preferred.
CAD, SolidWorks
2mo
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NPI Process Development Engineer
Franklin, Massachusetts, United States
$85k-$100k/yr OnsiteFull Time
4+ YOEFour or more years of engineering experience; bachelor's in mechanical or industrial engineering; strong interpersonal/negotiation skills; experience with medical devices and ISO 13485; process validations (IQ/OQ/PQ); familiarity with Microsoft Project and SolidWorks.
Microsoft Project, SolidWorks
1mo
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Senior Supplier Quality Engineer
Westborough or Worcester or Center Valley or United States
$98k-$135k/yr HybridFull Time
5+ YOEBA/BS in life science, engineering, or physical science; 5+ years supplier quality engineering; experience with APQP/FAI/SCAR/SCN, ISO 9001/13485 and FDA processes; fiber-optic laser system or medical device experience preferred; ~20% travel.
2w
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Design Assurance Engineer III - Urology
Marlborough or Valencia or Maple Grove or Minnetonka
$82k-$156k/yr HybridFull Time
3+ YOEBachelor's in engineering, 3+ years in design assurance or regulated medical device industry, experience with quality tools and technical documentation, strong communication and problem-solving; English and French required.
1mo
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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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Sr. Packaging Engineer, Vernon Hills, IL
Vernon Hills or Warwick
$96k-$153k/yr OnsiteFull Time
5+ YOEBachelor's in Packaging, Mechanical, Biomedical Engineering or related field; 5–8 years packaging engineering in medical device/pharma; ISO 11607-1/2, ISO 13485, ISO 16975, ICH, ASTM/ISTA; DFSS, DOE; FEA; CAPE/TOPS/SolidWorks experience.
CAPE, TOPS, SolidWorks
1mo
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Systems Security Engineer
Dedham or Taunton
$124k-$132k/yr OnsiteFull Time
5+ YOEBachelor's in Systems Engineering or related field, 5+ years' relevant experience (or Master's +3 yrs). DoD Secret clearance and U.S. citizenship required. Experience with NSA-certified cybersecurity devices, MBSE, real-time embedded systems; CISSP/INCOSE certifications preferred.
Model-based Systems Engineering (MBSE), Agile, AI
1mo
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Lead Laser Component Reliability Engineer
Oxford, Massachusetts, United States
OnsiteFull Time
3+ YOEMaster's (or PhD) in reliability engineering, EE, physics, or materials with 3+ years; strong reliability engineering, statistics, DOE, accelerated life testing, and experience analyzing optoelectronic/semiconductor device reliability; Python/R proficiency.
Python, R, SEM, FIB, EDX
1w
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Senior R&D Engineer-Sustaining
Marlborough, Massachusetts, United States
$89k-$170k/yr HybridFull Time
5+ YOEBachelor's in Mechanical Engineering or related, 5+ years product development experience in a regulated industry, knowledge of medical device quality/regulatory standards, strong problem solving and cross-functional collaboration.
CAD, Data Analysis, DMAIC
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