3w
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Associate Director, Device Development
Boston, Massachusetts, United States
$160k-$240k/yr HybridFull Time
8+ YOE8+ years device or combination-product development experience, bachelor\u0002s in engineering, knowledge of design controls/DHF/risk management/human factors, experience through commercialization, ability to lead cross-functional teams.
2d
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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.
2d
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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.
3mo
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Sr. Engineer, Device Development - CONTRACT
Bedford, Massachusetts, United States
$68-$72/hr OnsiteFull Time, Contract
8+ YOE8+ years in medical device design, development and testing; BS in Mechanical or Biomedical Engineering; knowledge of design controls and ISO standards; 3D modeling with SolidWorks/ProEngineer; GD&T; regulatory/submission experience.
SolidWorks, ProEngineer, GD&T
1w
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Device Development Lead, Associate Director
Lexington, Massachusetts, United States
$154k-$243k/yr OnsiteFull Time
12+ YOEBS/BEng in engineering/science,12+ years device development and commercialization experience,program and cross-functional leadership,capital equipment end-to-end experience,knowledge of FDA/EU MDR,budgeting and risk management.
Microsoft Project
6d
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Associate Director, Device Engineering
Waltham, Massachusetts, United States
$159k-$195k/yr HybridFull Time
10+ YOE3+ Mgmt10+ years medical device or combination product development experience with 3+ years leadership; expertise in autoinjectors/prefilled syringes/multidose pens, design controls, risk management, verification/validation, human factors, and regulatory submissions.
1mo
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Head of Quality, Device and Combination Products
Cambridge, Massachusetts, United States
HybridFull Time
12+ YOE5+ MgmtBS in engineering, 12+ years medical device quality/engineering/packaging experience with ≥5 years clinical/device quality and people management; deep knowledge of device regulations and QMS; supplier, CMO, and audit experience.
QMS, CAPA, GxP, 21 CFR 820, 21 CFR Part 4, ISO 13485, ISO 14971, EU Medical Device Regulation
4w
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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.
3w
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Sr. Software Development Manager
North Reading, Massachusetts, United States
OnsiteFull Time
10+ YOE5+ Mgmt5+ years managing engineering teams, 10+ years software development including embedded/device experience, experience with Agile, program management, simulation/emulation platforms, and building CI/CD and HIL testbeds.
simulation platforms, emulation platforms, HIL, CICD
3mo
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Director, Business Development
Burlington, Massachusetts, United States
$145k-$175k/yr OnsiteFull Time
5+ YOEMBA or advanced degree; 5+ years in medical device; strong financial modeling; collaboration and communication.
Financial Modeling
2mo
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Senior Business Development Manager
Boston or Toronto or Seattle or Chicago
RemoteFull Time
7+ YOE7-12+ years in business development, corporate strategy, or strategy consulting; MBA preferred; experience in consumer electronics, SaaS, or connected devices; proven ROI-driven opportunities; strong negotiation; cross-functional collaboration; open to remote US.
1mo
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Senior Software Development Engineer (Embedded Software)
Wilmington, Massachusetts, United States
$118k-$166k/yr HybridFull Time
3+ YOEMaster's in EE or related and 3+ years developing embedded software, device drivers, and frameworks for RF/MEMS/SoC products; expertise in ARM Assembly, C/C++, DSP, Python, MATLAB, CI/CD, sensor fusion and GNSS.
ARM Assembly, C/C++, Python, MATLAB, CI/CD
3d
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Product Development Engineer
Danvers, Massachusetts, United States
$76k-$122k/yr OnsiteFull Time
BS in Mechanical or Biomedical Engineering required; device development, prototyping, testing, risk and design documentation experience; ability to travel up to 20%; strong communication and cross-functional collaboration skills.
Solidworks, AutoCAD, Microsoft PowerPoint
2mo
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Senior Software Engineer, Device Integrations
Boston, Massachusetts, United States
$91k-$228k/yr RemoteFull Time
5+ YOE5+ years software development; Java or similar OO language; API-based integrations; relational DBs; remote work; SDLC knowledge; strong problem solving and communication.
Java, Spring Boot, Grails, Groovy, SQL, REST, JSON, XML, AWS, Kubernetes, Git
3w
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Principal Reliability Engineer-Medical Device Development
Merrimack, New Hampshire, United States
OnsiteFull Time
8+ YOE3+ MgmtBachelor’s or Master’s in engineering/related, 8+ years engineering experience including ≥3 years reliability engineering, experience with Weibull and statistical tools, HALT/HASS familiarity, strong root cause and leadership skills.
Weibull, Minitab, JMP, ReliaSoft, Dayforce
2mo
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Senior Clinical Development Scientist
Bothell or Cambridge
$148k-$237k/yr HybridFull Time
7+ YOE7+ years clinical experience in FDA-regulated medical devices; expertise in clinical research, RWE, trial design, GCP/FDA/EU-MDR; strong writing and collaboration skills; Master’s degree required, MD/PhD preferred.
GCP, FDA regulations, EU-MDR, Biostatistics, Clinical Trial Design
4d
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Manager, Programs & Content Development
Danvers, Massachusetts, United States
$117k-$201k/yr RemoteFull Time
5+ YOEBachelor's degree required; 5+ years in medical education or medical device/pharma roles; strong clinical/product knowledge, project management, training development, and stakeholder collaboration; travel up to 50%.
1w
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Development Quality Engineer
Westford, Massachusetts, United States
$61k-$123k/yr OnsiteFull Time
2+ YOEBachelor's in engineering (electrical preferred) plus 2+ years experience or Master's with 0+ years; knowledge of process and quality engineering, FMEA, data analysis, and medical device manufacturing.
2d
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Senior Scientist, Drug Product and Formulation Development
Woburn, Massachusetts, United States
$160k-$198k/yr OnsiteFull Time
5+ YOEPhD or Master's in related discipline, 5+ years industry experience (PhD) or 8+ years (Masters) in drug product/formulation development, hands-on experience with injectable DP unit operations, container/closure and device compatibility, strong documentation and communication skills.
AKTA, Unicorn, qPCR, Size exclusion-HPLC, Bilayer interferometry, dynamic light scattering, mass photometry, mass spectroscopy
2w
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Lead Product Development Engineer, R&D
Marlborough or Newark
$119k-$187k/yr OnsiteFull Time
8+ YOELead complex regulated medical device product development, design control, risk management (ISO 14971), V&V, and design transfer; strong systems engineering, manufacturing and DFx experience.
ISO 14971, ISO 13485, DFSS, DOE, Minitab, GD&T, SolidWorks
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