ECI: Provides regulatory and engineering consulting for life sciences companies.
5+ YOEBachelor's in engineering or equivalent, 5+ years R&D medical device experience with electromechanical devices, knowledge of FDA quality systems and ISO standards, experience with SPC/DOE/ANOVA/FMEA/CAPA and validation (IQ/OQ/PQ).
SPC, DOE, ANOVA, GR&R, FMEA, CAPA, IQ, OQ/PQ, FDA 21CFR820, ISO 13485, ISO 14971, ISO 11607
GRA Device Associate - Medical Devices and Combination Products (Senior Manager)
Morristown or Cambridge or Framingham
$122k-$177k/yrHybridFull Time
SanofiEuronext Paris: SAN: Researches, develops, and manufactures medicines and vaccines globally.
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.
Staff Design Control Engineer, Design Quality (IVD/CDx/Medical Device))
Marlborough, Massachusetts, United States
$105k-$125k/yrHybridFull Time
Quest DiagnosticsNYSE: DGX: Provides clinical laboratory diagnostic testing and health information services.
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).
Tegra MedicalSIX Swiss Exchange: SFSN: Contract manufacturer of components and finished medical devices.
3+ YOEBachelor's in engineering required; experience with manufacturing process development, troubleshooting, validation, and structured problem-solving; 3+ years preferred; medical-device experience preferred.
Principal Design Quality Assurance Engineer - Endoscopy
Marlborough, Massachusetts, United States
$107k-$203k/yrHybridFull Time
Boston ScientificNYSE: BSX: Manufacturer of interventional medical devices and technologies.
8+ YOEBachelor's in engineering,8+ years medical device engineering,deep knowledge of US/International device regulations,experience with risk management and design controls,10-20% travel.
UFP TechnologiesNasdaq: UFPT: Designs and manufactures custom medical devices and sterile packaging.
0+ YOEBachelor's in Engineering, up to 2 years manufacturing experience, CAD experience, knowledge of lean manufacturing and medical device regulations, strong communication and organizational skills.
Helen of TroyNASDAQ: HELE: Designs and markets branded consumer housewares and personal care products.
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
IPG PhotonicsNASDAQ: IPGP: Develops and manufactures high-performance fiber lasers and systems.
2+ YOE2+ years medical device/regulatory engineering experience; V&V planning and execution, IQ/OQ/PQ and TMV, ISO 13485/FDA QSR/ISO 14971 knowledge, MATLAB/Minitab and data acquisition proficiency, hands-on mechanical test equipment experience.
AbbottNYSE: ABT: Manufactures medical devices, diagnostics, and nutritional health products.
3+ YOEBachelor's in electrical/electronics engineering,3+ years electrical design experience in regulated industries,PCB design and layout,analog/digital circuit design,testing and validation,knowledge of design controls and medical device standards.
Altium, OrCAD, PADS, oscilloscopes, logic analyzers, power analyzers
JabilNYSE: JBL: Provides manufacturing and supply chain solutions for global brands.
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
MedtronicNew York Stock Exchange: MDT: Develops and manufactures medical devices and digital health solutions.
3+ YOEAdvanced systems engineering experience in medical device imaging, leading cross-functional projects, system-level design, validation, and image quality optimization; advanced degree or extensive experience required.
InsuletNasdaq: PODD: Manufactures wearable tubeless insulin pumps for diabetes care.
1+ YOEB.S. in Mechanical Engineering with 2+ years medical device experience (or M.S. with 1 year); experience with validations, SolidWorks, Excel, Minitab/JMP, cGMP/FDA environment; up to 50% travel.
Microsoft Office, Microsoft Excel, Minitab, JMP, Solidworks
HologicNASDAQ: HOLX: Develops medical technology for women's healthcare and diagnostics.
3+ YOEBSc/MSc in engineering with 3–8 years relevant electromechanical product development experience; systems integration, SolidWorks, SysML/INCOSE knowledge; embedded firmware and medical device experience preferred.
Westborough or Worcester or Center Valley or United States
$98k-$135k/yrHybridFull Time
OlympusTokyo Stock Exchange: 7733: Manufactures medical endoscopes and minimally invasive surgical tools.
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.
Senior Electrical Engineer – Medical Imaging (Bedford, MA)
Bedford, Massachusetts, United States
OnsiteFull Time
PhilipsEuronext Amsterdam: PHIA: Manufactures medical imaging systems and personal care appliances.
5+ YOE5+ years in electrical engineering; medical devices or regulated industries preferred; PCB design (Altium); analog/digital circuits; IEC 60601-1, EMC; Bachelor's or Master's in Electrical Engineering.
IPG PhotonicsNASDAQ: IPGP: Designs and manufactures high-performance fiber laser systems.
3+ YOEBachelor's in engineering,3-5 years post-market surveillance experience in medical devices,knowledge of medical device regulations,complaint investigations,statistical analysis,risk management (ISO 14971),strong technical writing and cross-functional collaboration.
Syner-G BioPharma Group: Provides CMC and regulatory services for life sciences companies.
5+ YOEBachelor's degree and 5+ years in pharma/biotech or medical device manufacturing; expertise in terminal sterilization, CQV/validation and GMP; strong technical writing and cross-functional collaboration skills.
Arden Hills or Maple Grove or Minnetonka or Marlborough or Irvine
$85k-$162k/yrHybridFull Time
Boston ScientificNYSE: BSX: Developer and manufacturer of innovative medical devices and therapies.
5+ YOEBachelor's in engineering, 5+ years in design assurance or medical device development, strong quality tools knowledge, technical writing, risk management, and design control experience.
Brady CorporationNYSE: BRC: Manufacturing industrial identification and workplace safety solutions.
2+ YOEBachelors in a technical field and 2+ years developing real-time embedded systems in C/C++; experience with RTOS/POSIX, Embedded Linux, device drivers, hardware debugging, and industrial networking.