- Beckman Coulter Life Sciences (Indianapolis, IN)
- …experience in product development, manufacturing and / or quality systems (ISO 9001), medical device (ISO 13485), pharmaceutical, related life sciences or other ... processes with teams across Beckman Coulter Life Science products including instrumentation, software and consumables.This position reports to the Jim Taller and is… more
- Beckman Coulter Diagnostics (Miami, FL)
- …a plus if you also possess previous experience in: Experience in IVD Medical device or Pharmaceutical ManufacturingASQ CertificationThe salary range for this ... with 3+ years of experience, OR Doctoral degree in fieldExperience in software , test method, equipment, process, and/or design testing methodologies.Knowledge of FDA… more
- AbbVie (North Chicago, IL)
- …Instagram, YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Manager, Medical Device Quality - Software will act as the ... lead in support of a broad portfolio of on-market medical devices including Software as a Medical Device (SaMD) and Software in a Medical … more
- AbbVie (North Chicago, IL)
- …understanding of principles and practice of Design Controls (CFR 820.30 / ISO 13485), Medical Device Software Lifecycle (ISO 62304), and Risk Management (ISO ... with 10+ years of experience (MS preferred) + Experience must include significant device development, with medical device , pharmaceutical or other regulated… more
- US Tech Solutions (San Bruno, CA)
- …system issues. **Mandatory:** + 5+ years of experience in program management. + Experience in Medical Device Manufacturing or Software as a Medical ... screening. + The team develops and deploys hardware and software solutions to help screen for vision threatening eye...+ Managing cross-functional or cross-team projects to bring regulated medical device products to market. + Ensuring… more
- Belcan (Novi, MI)
- …IEC 60601, and FCA Class 2. This role requires a deep understanding of medical device software development, architecture, and regulatory requirements. Key ... organizational goals. * Advise on compliance with IEC 62304 standards for medical device software lifecycle processes. * Consult on the implementation and… more
- Abbott (Atlanta, GA)
- …+ Experience working with BLE and NFC. + Experience with Class II or III implantable medical device software development. + 5+ years in the medical ... industry + Strong knowledge of FDA and international regulatory requirements for medical device software + Knowledge within the medical device… more
- US Tech Solutions (San Bruno, CA)
- …frameworks, and support CAPA, complaints, audits, and overall QMS functions. **Experience:** ** Medical Device Software Experience:** 1. Proven experience in ... experience in standalone software development, with a solid understanding of medical device software standards such as IEC 62304. ** Software Quality… more
- Abbott (St. Paul, MN)
- …final release according to medical device development processes. + Develop Medical Device software using OpenGL. + Work closely with cross-function ... Computer Systems, or Software ), Computer Science, or related discipline. + Medical device development experience and IEC60601-1, IEC62304 and related IEC… more
- Medtronic (Mounds View, MN)
- …to Have:** + Strong Embedded Design and regulatory experience, especially post-market/released medical device software + Self-starter with strong ... design control procedures used within the medical device industry. As a Senior Software Engineering...medical device industry. As a Senior Software Engineering Manager in the Cardiac Rhythm Management organization,… more
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