19 medical device engineer jobs at 11 companies in Keller, TX
2d
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Process Engineer
Irving, Texas, United States
OnsiteFull Time
Associate degree required; engineering degree preferred. Requires relevant professional and engineering experience, problem-solving, communication, prioritization, and project management skills. Medical device experience preferred.
Lean, Six Sigma, Corrective and Preventive Action (CAPA)
3w
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Senior Quality Engineer, Cybersecurity
Dallas or Boston or San Bruno
$113k-$170k/yr HybridFull Time
5+ YOE5+ years software quality engineering in regulated medical device/SaMD, medical device cybersecurity expertise, knowledge of IEC/ISO standards, experience with risk management and secure SDLC, proficiency with Jira/GitHub/Google Workspace.
Google Workspace, Jira, GitHub, Gemini, Claude, ChatGPT
4d
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Systems Engineer II
Fort Worth, Texas, United States
$89k-$133k/yr OnsiteFull Time
2+ YOEBachelor's degree in engineering or science with 2 years of relevant experience, or master's degree with no experience. Requires systems engineering, medical device, hardware, CAD, prototyping, risk, and project leadership skills.
Computer-Aided Design (CAD)
3mo
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Senior Process Engineer
Dallas, Texas, United States
OnsiteFull Time
10+ YOEBachelor’s in Engineering; 10+ years electronics manufacturing; PCB knowledge; DFx; Lean/Six Sigma; ISO/medical device experience preferred.
Aegis Factory Logix, CAM350, PLM, ERP
1mo
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Safety Engineer
Irving, Texas, United States
$45-$55/hr OnsiteFull Time
6+ YOE6+ years product safety experience in medical devices, bachelor in engineering, hands-on knowledge of safety test methods (UL/CSA/IEC 61010), ISO 17025, EMC assessments, cGMP practices, metrology, and strong communication.
Cadence Spectre, Form FDA 3632
4w
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Design Engineer
Irving, Texas, United States
OnsiteFull Time
1+ YOEDesigning medical device components using SolidWorks, creating ASME Y14.5 manufacturing drawings, performing GD&T tolerance analysis, and ensuring manufacturability. Bachelor's in Engineering or equivalent and 1-3 years product design experience; U.S. work authorization required.
Solidworks, Microsoft Excel, Microsoft Word, Microsoft Outlook
1w
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Staff Engineer - MedTech Surgery - R&D
Irving, Texas, United States
$109k-$175k/yr HybridFull Time
8+ YOEBachelor's degree in engineering or related field and 8+ years in medical device or regulated-field R&D and commercialization; requires design control, statistics, MS Office, and PLM experience.
Microsoft Office, Windchill, SAP Product Lifecycle Management, Design of Experiments (DOE)
1w
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Staff Engineer - MedTech Surgery - R&D
Irving, Texas, United States
$109k-$175k/yr HybridFull Time
8+ YOEBachelor's degree in mechanical or biomedical engineering or related field, 8+ years in regulated medical device or pharmaceutical R&D, design control, statistics, MS Office, and PLM experience required.
Microsoft Office, Windchill, SAP Product Lifecycle Management, Design of Experiments (DOE), CFR 820.30
2d
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Principal R&D Engineer: NPD for Cranial, Spinal Technologies
Fort Worth, Texas, United States
$131k-$197k/yr OnsiteFull Time
5+ YOEBachelor's degree in mechanical engineering or STEM with 7+ years of related experience, or an advanced degree with 5+ years. Requires medical-device development, QMS, risk management, and engineering analysis experience.
Electronic Medical Records (EMR), Microsoft Office, ProEngineer, Failure Mode and Effects Analysis (FMEA), IEC 60601, ISO 13485, GD&T
1w
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Senior Development Quality Engineer
Plano, Texas, United States
$87k-$173k/yr OnsiteFull Time
5+ YOEBachelor's degree in engineering or a technical field, or equivalent experience; 5+ years of quality engineering experience; quality methodologies, root-cause investigation, statistical analysis, and medical-device regulations preferred.
ISO 14971, FDA QMSR, EU MDR, Design History File (DHF), FDA 21 CFR Part 820, ISO 13485, EN 45502-1, ISO 14708
1w
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Sr. Procurement Project Engineer
Plano, Texas, United States
OnsiteFull Time
7+ YOEBachelor's in engineering or technical field,7+ years medical device experience,strong supplier qualification/validation and regulatory knowledge,advanced MS Office/Excel/Project and ERP/PLM skills,excellent communication and negotiation.
Microsoft Office, Microsoft Excel, Microsoft Project, Agile, ETQ, SAP, QAD
1mo
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Director of Engineering
Dallas, Texas, United States
$200k-$225k/yr HybridFull Time
10+ YOEBachelor's in engineering required (advanced degree preferred); 10+ years medical device/combination product experience; experience with electromechanical and software-enabled devices, FDA-regulated development, design controls, V&V, risk management, and people leadership.
Microsoft Office, SolidWorks, eQMS, ALM
2mo
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Senior Manager, Product Innovation Engineering
Allen, Texas, United States
OnsiteFull Time
7+ YOELead product and process innovation in medical devices; 7-10 years in product development/R&D; bachelor’s in engineering; MBA or graduate degree preferred.
Ascend Strategy, NBS Next, Regulatory compliance, Product development tools
1mo
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Director, Sales & Clinical Applications - Nordson Medical Surgical Solutions
Allen, Texas, United States
OnsiteFull Time
10+ YOE10+ years medical device sales/account leadership with P&L responsibility, bachelor's in engineering required, supervisory experience, CRM and MS Office proficiency, strong communication and strategic selling skills.
Microsoft Office, CRM, NBS Next
3w
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Associate Product Manager – Global & Upstream
Austin or Plano
$87k-$173k/yr OnsiteFull Time
3+ YOEBachelor's degree, 3+ years in medical device or related industry in marketing/sales/clinical/engineering, strong analytical and product-marketing skills, project management and communication, ability to travel up to 15%.
3w
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Associate Product Manager – Global & Upstream
Austin or Plano
$87k-$173k/yr OnsiteFull Time
3+ YOEBachelor's degree; 3+ years in medical device or related industry in marketing/sales/clinical/engineering; strong analytical, communication, product launch and project management skills; ability to work with global teams.
2mo
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Clinical Study Manager
Plano, Texas, United States
OnsiteFull Time
3+ YOEBachelor’s in Life Sciences, Engineering, or related field; 3–8+ years clinical research; 2+ years medical device study management; ISO14155/FDA/GCP knowledge; EDC/CTMS/eTMF proficiency.
EDC, CTMS, eTMF
2mo
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Director, Regulatory Affairs
Plano, Texas, United States
OnsiteFull Time
8+ YOEBS/MS in biomedical engineering, science, or related; 8+ years progressive medical device or regulatory agency experience; deep knowledge of FDA and global regulatory requirements, QMS and standards; leadership and communication skills; 10–20% travel.
1mo
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Quality Engineering Technician
Dallas, Texas, United States
$80k/yr OnsiteFull Time
2+ YOE2+ years quality inspection or technician experience in medical device or regulated environment; ability to read drawings, use multimeter and precision measuring tools, perform visual inspection, follow cGMP/ISO, and use MS Office; able to lift up to 40 lbs.
G Suite, Microsoft Outlook, Microsoft Word, Microsoft Excel, Adobe, Salesforce CRM, multimeter
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