5+ YOEBachelor's degree in a technical field and 5+ years of medical device or digital health design quality experience. Requires ISO 13485 QMS, design controls, risk management, CAPA, complaints, and post-market surveillance expertise.
EHR, ISO 13485, FDA QMSR, ISO 14971, 510(k), Software as a Medical Device (SaMD), software in a medical device (SiMD)
TAE Technologies: Developing commercial fusion energy and advanced power management technologies.
5+ YOE5+ years medical device quality experience (ISO 13485, 21 CFR Part 820), BS in technical or life science, strong writing and analytical skills, experience with design controls, test planning, and cross-functional collaboration.
Boston ScientificNYSE: BSX: Developing and manufacturing innovative medical devices for less-invasive treatments.
10+ YOE5+ MgmtBachelor's degree in engineering or related technical field, 10+ years in medical devices or regulated industry, 5+ years of people leadership, and expertise in Design Controls, Risk Management, Quality Systems, FDA regulations, ISO 13485, and ISO 14971.
Design Controls, Risk Management, Quality Systems, FDA Quality System Regulations, ISO 13485, ISO 14971, CAPAs, NCEPs
Senior Design Quality Engineer for Connected Products
Orange, California, United States
HybridFull Time
Fieldpiece Instruments: Designs and manufactures professional-grade HVACR diagnostic tools.
5+ YOEBachelor's in engineering or STEM,5+ years in design quality/V&V for electro-mechanical products,experience with hardware/firmware/software lifecycle,DFMEA/Design for Reliability,risk management,root cause analysis,and working with global manufacturers.
TAE Technologies: Developing commercial fusion power for clean, carbon-free energy.
5+ YOEBS in technical or life science,5+ years in medical device quality systems (ISO 13485,21 CFR 820),strong technical writing,test planning,verification/validation experience,MS Office proficiency,and ability to travel up to 90 days/yr.
Seattle or Houston or Chicago or Los Angeles or Austin or San Francisco or New York or Dallas or San Diego or Phoenix or Boston or Washington
$140k-$168k/yrHybridFull Time
Arup: Global professional services firm for the built environment.
10+ YOE5+ MgmtDegree in engineering/architecture,10+ years design delivery experience,5+ years quality management,strong design governance and coordination skills; PMP/CMQ/OE/ISO9001/PE preferred.
EnvistaNYSE: NVST: Manufactures and sells a comprehensive range of dental products.
10+ YOE5+ MgmtBachelor's in Engineering, 10+ years in regulated industry, 5+ years leading teams; expertise in design controls, supplier quality, validation, CAPA, audits, and digital quality systems.
Boston ScientificNYSE: BSX: Developer and manufacturer of innovative medical devices and therapies.
10+ YOE5+ MgmtBachelor's degree in engineering or related technical field, 10+ years in medical devices or regulated industries, 5+ years of people leadership, and expertise in design controls, risk management, quality systems, FDA regulations, ISO 13485, and ISO 14971.
FDA Quality System Regulations, ISO 13485, ISO 14971
Boston ScientificNYSE: BSX: Manufacturer of interventional medical devices and technologies.
10+ YOE5+ MgmtBachelor's degree in engineering or related technical field; 10+ years in medical devices or regulated industry; 5+ years of people leadership; expertise in design controls, risk management, quality systems, FDA regulations, ISO 13485, and ISO 14971.
Design Controls, Risk Management, FDA Quality System Regulations, ISO 13485, ISO 14971, CAPAs, NCEPs
Copy Of Senior Design Quality Assurance Engineer #2320
Santa Clarita, California, United States
OnsiteFull Time, Contract
ECI: Provides regulatory and engineering consulting for life sciences companies.
10+ YOE10+ years medical device quality experience, bachelor's in engineering preferred, strong design control and regulatory knowledge, DHF experience, Minitab experience, excellent communication and analytical skills.
New World Medical: Develops and manufactures surgical devices for glaucoma treatment.
7+ YOEBachelor’s degree in engineering or science, 7+ years in medical devices, and expertise in design controls, risk management, validation, QMS requirements, statistics, and cross-functional technical leadership.
Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Minitab, IQ/OQ/PQ
Tata Consultancy ServicesNational Stock Exchange of India: TCS: Global provider of IT services, consulting, and business solutions.
6+ YOE6+ years aerospace mechanical design experience, NPI and sustaining engineering, customer interaction, data triage, SolidWorks/CATIA and MATLAB Simulink proficiency, US national required.
Premarket Quality Engineering Director (ICT), Santa Ana, CA
Santa Ana, California, United States
$198k-$298k/yrOnsiteFull Time
MedtronicNYSE: MDT: Developing and manufacturing medical technologies and therapies globally.
10+ YOE7+ MgmtBachelor's degree, ~10 years relevant experience with 7+ years managerial experience; expertise in design controls, risk management, product development quality and program leadership.
Design Quality Manager in Seattle, Washington, United States
Seattle or Houston or Chicago or Los Angeles or Austin or San Francisco or New York or Dallas or San Diego or Phoenix or Boston or Washington
$140k-$168k/yrHybridFull Time
Arup: Provide engineering and design services for the built environment.
10+ YOE5+ MgmtDegree in engineering/architecture,10+ years design delivery experience,5+ years quality management experience,design leadership and quality management expertise; PMP, CMQ/OE, ISO9001 lead auditor, PE preferred.
Premarket Quality Engineering Director (ICT), Santa Ana, CA
Santa Ana, California, United States
$198k-$298k/yrOnsiteFull Time
MedtronicNew York Stock Exchange: MDT: Develops and manufactures medical devices and digital health solutions.
10+ YOE7+ MgmtBachelors degree and ~10 years relevant experience with 7+ years managing teams; expertise in design controls, risk management, program execution, and regulatory compliance.
Design Quality Manager in Seattle, Washington, United States
Seattle or Houston or Chicago or Los Angeles or Austin or San Francisco or New York City or Dallas or San Diego or Phoenix or Boston or Washington
$140k-$168k/yrHybridFull Time
Arup: Global engineering and design consultancy for the built environment.
10+ YOE5+ MgmtDegree in engineering/architecture,10+ years design delivery experience,5+ years quality management experience,PMP/CMQ-OE/ISO9001/PE preferred,strong leadership and stakeholder skills.
Design Engineer — App Store & Games Product Design Team
Culver City, California, United States
OnsiteFull Time
AppleNASDAQ: AAPL: Designs and sells consumer electronics, software, and online services.
Technical builder embedded in product design, developing engineering infrastructure, tooling, and workflows that help designers create and ship production-quality prototypes.
Stevanato GroupNYSE: STVN: Manufacturer of pharmaceutical drug containment and delivery systems.
8+ YOE8+ years quality engineering in medical device/combination products, bachelor\u0002s in engineering, CQE/CQA or Six Sigma, experience with validation (IQ/OQ/PQ), design controls, supplier quality, and regulatory compliance (ISO 13485, FDA QSR).
AbbottNYSE: ABT: Manufactures medical devices, diagnostics, and nutritional health products.
5+ YOEBachelor's degree in engineering or technical field or equivalent experience; 5+ years in quality, design quality, reliability, electrical engineering, or medical devices; experience with design controls, risk management, FDA, GMP, and ISO standards.