- 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
- 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
- Teleflex (Morrisville, NC)
- …and reports, coding reviews, and software releases. + Establish the best medical device software development practices within the growing business ... in a regulated environment ( medical devices, automotive, aviation). * Experience with medical device regulatory standards such as 21 CFR Part 820, IEC 60601,… more
- Abbott (Irving, TX)
- … Device Directive, ISO guidelines, 21 CFR Part 11 and IEC 62304 Medical Device Software - Software life cycle processes. + Project experience in ... Our Irving, TX location is looking for a Sr. Software Design Quality Engineer. This person will be responsible...design control for On-Market and In-Development activity in the Medical Device space. It is expected to… more
- Medtronic (Newton, MA)
- … development life cycle, following FDA regulations and IEC 62304 for medical device software . **Must-Have:** **Minimum** **Requirements** + Bachelor's ... considering cross-functional dependencies and overall business goals. Experience working in the medical device industry with understanding of regulations such as… more
- Motion Recruitment Partners (Atlanta, GA)
- …for a DevOps role where you can apply your embedded software expertise? A medical device software company located in the heart of Atlanta is looking ... redo and build CI/CD pipelines to deliver this embedded software to the medical devices this company...as needed + BS in Computer Science + Prior medical device or healthcare industry experience +… more
- Stryker (Portage, MI)
- …**Manager, Software Design Quality** to manage a team of Design Quality engineers that work on Software as a Medical Device (SiMD) or Software in a ... you will do:** + Manage and develop a team of design quality engineers supporting Software as a Medical Device (SaMD) and Software in a Medical … more
- Abbott (Burlington, MA)
- …EU Medical Device Regulations and MDSAP + Experience with medical device software development lifecycle for Cloud-based networks and/or mobile ... product software (Cloud Patient Care Networks, mobile applications and embedded software ), non- medical software , and non-product software + Support … more
- BioFire Diagnostics, LLC. (San Jose, CA)
- …+ 5+ plus years software development experience, with a strong emphasis on medical device software or regulated fields. + Write clean, testable code ... a healthcare setting. + Knowledge of FDA regulations and standards related to medical device software development will be an advantage. + Excellent written… more
- BioFire Diagnostics, LLC. (Salt Lake City, UT)
- …execute test plans. They are expected to understand the regulatory requirements regarding medical device software development and cybersecurity, and educate ... responsible for all aspects of the Quality System requirements for production level medical device software . Required: + Bachelor's degree in a software ,… more
- Stryker (Portage, MI)
- …Engineer, Design Assurance** to support our Medical 's Digital Health division and portfolio Software as a Medical Device (SiMD) or Software in ... medical device regulations (820, IEC 62304/82304, 60601), with experience in Software as a Medical Device (SaMD), Software in a Medical … more
- Stryker (Kalamazoo, MI)
- …Quality Engineer, Post Market** to support our Medical 's Digital Health division and portfolio Software as a Medical Device (SaMD)/ Software in a ... in software technical support resolution within the medical device industry, ensuring compliance with regulatory... software testing and/or verification/validation. + Experience with Software as a Medical Device … more
- J&J Family of Companies (Cincinnati, OH)
- …designs and specifications per design control processes. Conform to Industry Standards for Medical Device Software (IEC 62304) Responsibilities will increase ... with our NPD teams to design and develop product software for use in cutting edge medical ...product software for use in cutting edge medical devices and associated capital equipment. **Key Responsibilities:** As… more
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