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
Milwaukee or Chelmsford or Mequon or Austin or Mayfield Heights
HybridFull Time
Rockwell AutomationNYSE: ROK: Sells industrial automation hardware and digital manufacturing software solutions.
5+ YOEDefine device integration strategy and architecture for intelligent devices, guide standards and roadmaps, present to senior leaders, mentor technical talent, US work authorization required, ability to travel up to 25%.
PCI Pharma Services: Integrated pharmaceutical development, manufacturing, and global packaging services.
5+ YOEBachelor's degree in engineering and 5+ years of engineering, facilities, clean utilities, or plant utilities experience, preferably in biotechnology, medical device, or pharmaceutical manufacturing.
Computerized Maintenance systems (CMMS), AutoCAD, SolidWorks, PLC, SCADA, Microsoft Word, Microsoft Excel, Microsoft Project, Microsoft PowerPoint
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).
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.
ZOLL Medical: Manufactures medical devices and software for emergency care.
3+ YOEB.S. in Mechanical Engineering, 3+ years mechanical/product design experience; SolidWorks proficiency; knowledge of medical device regulations; strong communication and analytical skills.
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.
GetingeNasdaq Stockholm: GETI B: Manufactures medical equipment for acute care and life sciences.
5+ YOEBachelor's in engineering,5+ years in medical device or regulated industry,experience with design controls and 21 CFR Part 820,ability to lead cross-functional teams,Microsoft Office proficiency,knowledge of GDP.
Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Agile PLM, Minitab
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.
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.
InsuletNasdaq: PODD: Manufactures wearable tubeless insulin pumps for diabetes care.
6+ YOE6+ years systems engineering experience in product development, 4+ years in medical device or regulated industry, BS in engineering required (MS preferred), proficiency with requirements management tools (Jama, Polarion, Doors), strong risk management and regulatory knowledge.
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.
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.