StrykerNYSE: SYK: Manufactures medical devices and equipment for healthcare providers.
2+ YOEDesign and test sterile packaging for medical devices; packaging validation; cross-functional collaboration; 2+ years in regulated packaging environment.
Senior Quality System Engineer - Medical Device #0146
Mesa, Arizona, United States
OnsiteFull Time, Contract
ECI: Provides regulatory and engineering consulting for life sciences companies.
5+ YOEBachelor's in engineering (required), 5+ years experience, strong knowledge of ISO 9001 and QA methods, database proficiency, experience with audits, and professional certifications (Six Sigma, CQE, CQA) preferred.
Reprieve Cardiovascular: Developing intelligent fluid management systems for heart failure patients.
Design, analyze, test, and troubleshoot analog, digital, mixed-signal, and embedded electronic systems; support system integration, verification/validation, manufacturing transfer, and sustaining engineering for medical devices.
3+ YOEBachelor's degree in engineering or equivalent experience; 3+ years supporting high-technology electrical/electronic products and medical devices involving lasers and optics; electronic test equipment and MS Office skills; domestic and international travel required.
Innovative Health: Reprocesses single-use cardiology medical devices for hospitals.
6+ YOEBachelor's in engineering (or equivalent),6+ years R&D experience with electromechanical medical devices,test method development/validation,design controls and FDA knowledge,strong technical writing and hands-on prototyping skills.
Erbe: Develops and manufactures surgical systems and medical instruments.
7+ YOEBachelor's in engineering/science preferred, 7+ years medical device R&D/product development experience, strong knowledge of design controls, risk management, V&V, SOLIDWORKS and MINITAB experience preferred, proficiency with Excel and technical documentation.
DexcomNasdaq: DXCM: Manufacturer of continuous glucose monitoring systems for diabetes management.
2+ YOEBachelor's degree in a technical discipline with 2–5 years of related experience, or master's degree with 0–2 years. Requires medical device quality, hardware risk, postmarket surveillance, complaint investigation, and regulatory knowledge.
Continuous Glucose Monitoring (CGM), FDA 21 CFR Part 820, ISO 13485, ISO 14971, EU MDR, DFMEA, PFMEA, CAPA, Health Hazard Evaluations (HHEs)
Innovative Health: Reprocesses single-use cardiology medical devices for hospitals.
7+ YOEBachelor's in engineering (or equivalent), 7+ years R&D experience with electromechanical medical devices, test method development/validation, Design Controls and FDA/ISO knowledge, strong technical writing and prototyping skills.
Ziehm-Orthoscan: Manufactures and services mobile C-arm X-ray imaging systems.
7+ YOE7+ years software engineering experience, C++ and embedded Linux skills, QT/QML GUI experience, knowledge of medical device standards (IEC 62304), Git/CI/CD, and cross-functional collaboration.
AbbVieNYSE: ABBV: Develops and sells innovative pharmaceutical and biopharmaceutical medicines.
10+ YOEBachelor's in engineering required, Masters preferred.10-15 years manufacturing/engineering experience with leadership in medical device manufacturing; strong planning, communication, and compliance skills.
Caris Life SciencesNASDAQ: CAI: Provides molecular profiling and AI-driven precision medicine diagnostics.
3+ YOEBachelor’s degree in biological science, engineering, or a related field; 3+ years in an FDA-regulated laboratory, medical device, or pharmaceutical environment; knowledge of quality and regulatory standards.
Microsoft Word, Microsoft Excel, Microsoft Outlook, Internet, Master Site Validation Plan, standard operating procedures (SOPs), Quality Management System (QMS), Corrective Action Preventive Action (CAPA), Nonconformances (NONC), Microsoft Office Suite
Innovative Health: Reprocesses single-use cardiology medical devices for hospitals.
8+ YOEBachelor's degree in engineering,8+ years medical device R&D with Class III experience,knowledge of design controls/risk management/validation,leadership and communication skills.
Innovative Health: Reprocesses single-use cardiology medical devices for hospitals.
8+ YOEBachelor's in engineering required, 8+ years medical device R&D experience with Class III and electromechanical systems, strong knowledge of design controls, risk management, and validation; leadership and communication skills.
BioLab Holdings: Develops and manufactures regenerative medicine and wound care products.
5+ YOEBachelor's in Marketing/Business/Engineering, 5+ years product/marketing experience in tissue, biologics or medical device (wound care preferred), proficiency with Microsoft Office, strong communication and stakeholder influence, ability to travel up to 25%.