27 engineer medical devices jobs at 10 companies in Austin, TX
3mo
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3mo
Regulatory Engineer
Austin, Texas, United States
$71k-$119k/yrOnsiteFull Time
Neuralink: Developing implantable brain-computer interfaces to restore human capabilities.
1+ YOEBachelor’s degree in engineering with experience in regulatory submissions and quality engineering for medical devices; strong technical writing and cross-functional collaboration skills.
OriGen Biomedical: Manufactures medical devices for cryopreservation and cell culture.
4+ YOEBachelor's degree in engineering or 4+ years engineering experience in medical devices/ISO 13485, knowledge of FDA/GMP, DOE/validation, strong problem solving and communication skills.
AbbottNYSE: ABT: Manufactures medical devices, diagnostics, and nutritional health products.
7+ YOEBachelor's in engineering/science preferred or equivalent experience, minimum 7 years experience, engineering/project management/operational background, RCA and pFMEA experience, ability to lead projects, mentor engineers, and work with regulated medical device requirements.
Zimmer BiometNYSE: ZBH: Manufactures orthopedic implants and robotic surgical systems.
2+ YOEBachelor's degree in engineering and 2 years of relevant experience or equivalent; 3D modeling, SolidWorks, medical device, EMC and IEC 60601 testing experience required.
AbbottNYSE: ABT: Provides medical devices, diagnostics, and science-based nutritional products.
7+ YOEBachelor's in engineering/science preferred or equivalent experience, minimum 7 years engineering/project experience, strong technical and project management skills, medical device/regulatory knowledge preferred, ability to perform root cause analysis and mentor others.
DiaSorinBorsa Italiana: DIA: Develops and manufactures in vitro diagnostic tests and laboratory equipment.
2+ YOEBachelor's in engineering, 2+ years control/automation experience in regulated (medical device) environment, PLC/HMI programming, Python, SQL/Tableau/Power BI, SolidWorks, SCADA, IIoT/OPC/Kepware, ISO 13485/FDA knowledge, Six Sigma experience.
PLC, HMI, SQL, Tableau, Power BI, Python, SolidWorks, SCADA, IIoT, OPC, PTC Kepware, LabVIEW, MATLAB, Microsoft Word, Microsoft Excel, Microsoft PowerPoint
Siemens HealthineersFrankfurt Stock Exchange: SHL: Manufactures medical imaging and laboratory diagnostic equipment.
7+ YOEBachelor in engineering or life sciences,7+ years regulatory affairs experience with Class II/III devices,knowledge of global medical device regulations,submission experience (510(k),PMA,IDE),strong communication and judgment.
HeartFlowNASDAQ: HTFL: Provides AI-driven non-invasive cardiac diagnostic software and analysis.
13+ YOE7+ MgmtBachelor's degree in engineering or a scientific discipline and 13+ years of medical device quality experience, including 7+ years in leadership. Requires expertise in MDR, vigilance, post-market surveillance, and FDA/EU regulations.
AI, AI/ML, Software as a Medical Device (SaMD), 21 CFR Part 803, 21 CFR Part 806, EU MDR, ISO 13485, ISO 14971, FDA Quality Management System Regulation, MDSAP, CAPA, PMDA
Thermo Fisher ScientificNYSE: TMO: Sells equipment and chemicals for scientific research and healthcare.
7+ YOEBS in Molecular Biology, Genetics, or Engineering required; PMP preferred. 7+ years program management experience with regulated medical device or similar products; budget, risk, timeline, and external partner management; strong communication and financial skills.
Siemens HealthineersFrankfurt Stock Exchange: SHL: Provides medical imaging and diagnostic solutions to healthcare providers.
7+ YOEBachelor’s degree in Engineering or Life Sciences,7+ years regulatory affairs experience with Class II/III medical devices,experience with US/EU/Canada submissions,knowledge of 21 CFR/ISO/IEC standards,proficiency in MS Office,excellent communication and judgment.
Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Adobe