12 medical device engineer jobs at 3 companies in Delaware
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Senior Software Engineer, Medical Device
Newark, Delaware, United States
$107k-$167k/yrHybridFull Time
HologicNASDAQ: HOLX: Develops medical technology for women's healthcare and diagnostics.
5+ YOEExpert in .NET/C# and object-oriented design with strong CS fundamentals, multithreading, debugging, CI/CD and software architecture; 5+ years (Bachelors) or 4+ years (Masters) experience; mentoring and technical leadership skills; medical device experience a plus.
HologicNASDAQ: HOLX: Develops medical technology for women's healthcare and diagnostics.
1+ YOEBachelor’s degree in a technical engineering or computer science field, plus 1–2 years’ experience; requires systems engineering, electromechanical design, integration, medical device standards, PLM, and project skills.
HologicNASDAQ: HOLX: Develops medical technology for women's healthcare and diagnostics.
5+ YOEBachelor's in engineering required (Master's preferred); 8+ years (BS) or 5+ years (MS) medical device experience; expertise in design assurance, risk management, V&V, test validation, and global regulatory standards.
HologicNASDAQ: HOLX: Develops medical technology for women's healthcare and diagnostics.
8+ YOELead complex regulated medical device product development, design control, risk management (ISO 14971), V&V, and design transfer; strong systems engineering, manufacturing and DFx experience.
ISO 14971, ISO 13485, DFSS, DOE, Minitab, GD&T, SolidWorks
HologicNASDAQ: HOLX: Develops medical technology for women's healthcare and diagnostics.
3+ YOEExperience applying medical device regulations and standards, risk management (ISO 14971), software V&V, SDLC for safety-critical systems, and 3–5+ years medical device software experience; BSc/MS in relevant field.
HologicNASDAQ: HOLX: Develops medical technology for women's healthcare and diagnostics.
0+ YOEPerform complaint investigations, root cause analysis, risk assessment, data trending, and support corrective actions for on-market medical devices.
HologicNASDAQ: HOLX: Develops medical technology for women's healthcare and diagnostics.
12+ YOEExtensive embedded systems experience (RTOS, low-level firmware, device drivers), expert C/C++ and assembly skills, hardware/software integration, leadership and mentoring experience, familiarity with communication protocols (SPI, I2C, UART, CAN) and regulated medical device environments.
HologicNASDAQ: HOLX: Develops medical technology for women's healthcare and diagnostics.
Provide design control, risk management, verification/validation, and quality system support for regulated medical devices across the product lifecycle.
HologicNASDAQ: HOLX: Develops medical technology for women's healthcare and diagnostics.
Experience with medical device design controls, risk management, quality systems, V&V, and regulatory standards (FDA QSR, ISO 13485, ISO 14971, EU MDD/MDR).Bachelor's degree in engineering or related field required; advanced degree preferred.
HologicNASDAQ: HOLX: Develops medical technology for women's healthcare and diagnostics.
5+ YOEExpertise in design controls, risk management, quality systems, and medical device regulatory standards; 5+ years' related experience; strong problem-solving and communication skills.
Illinois or Connecticut or Colorado or California or Alabama or Georgia or Florida or Delaware or Arizona
RemoteFull Time
ToxStrategies: Scientific consulting firm specializing in toxicology and regulatory compliance.
10+ YOE10+ years systems engineering or technical lead experience in combination products/medical devices; BS required, MS preferred; experience with DHF, design controls, risk management, verification/validation, design transfer, and regulatory submissions.