• Olympus Corporation of the Americas (Westborough, MA)
    …to Agile SW development practices. This position provides subject matter expertise, technical guidance, and leadership for the application of health and medical ... ISO 81001-5-1, and AAMI TIR34971. This includes providing leadership, technical direction and collaboration on development strategies, concepts, design evaluation… more
    DirectEmployers Association (11/13/25)
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  • Lead SaMD Technical…

    Wolters Kluwer (Chicago, IL)
    The **Principal SaMD Technical Program Manager** plays a pivotal role in driving the development and delivery of Software as a Medical Device ( SaMD ) ... experience working on SaMD or regulated medical software products in technical program management, engineering, or project management roles using agile… more
    Wolters Kluwer (12/04/25)
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  • Principal TPM, SaMD (Remote)

    Oracle (Hartford, CT)
    …safety, risk management, usability, security, and post-market surveillance. **Key Responsibilities** ** SaMD Program Leadership** + Lead end-to-end planning ... , and related IMDRF SaMD principles. + 5+ years of technical program management experience, including leading complex engineering programs in regulated… more
    Oracle (12/11/25)
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  • Head of Medical Device & SaMD Quality

    Takeda Pharmaceuticals (Lexington, MA)
    …compliance with international regulatory requirements and Takeda Global procedures. + Lead and develop a global organization, fostering talent, accountability, and ... products, in vitro diagnostics (IVDs), and Software as a Medical Device ( SaMD ) across all business units, geographies, and therapeutic modalities spanning Takeda's… more
    Takeda Pharmaceuticals (10/10/25)
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  • GRA Device Lead (Associate Director)…

    Sanofi Group (Cambridge, MA)
    …development. Proficiency inpreparingregulatorydocumentationwith standard submission processes. + ** Technical Knowledge:** Understanding of clinical development of ... **Job Title:** GRA Device Lead (Associate Director) - Digital Health **Location:** Cambridge,...the product lifecycle. Our department bridges the gap between technical development, manufacturing operations, and global regulatory authorities to… more
    Sanofi Group (09/20/25)
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  • Principal Software and Security Compliance Audit…

    Medtronic (Minneapolis, MN)
    …and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, ... + Must have experience, subject matter expertise (SME), and technical knowledge working with regulated medical device software and...and awareness programs for Software as a Medical Device ( SaMD ), Software in a Medical Device (SiMD), and product… more
    Medtronic (12/16/25)
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  • Senior Area Innovation Manager, Endoscopy…

    Medtronic (Sacramento, CA)
    …and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, ... to validate the value proposition of Medtronic AI platforms + Initiate and lead engagements with internal cross-functional leaders to accelerate and close the sales… more
    Medtronic (10/11/25)
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  • Director of AI Optimization and Productization…

    J&J Family of Companies (Titusville, NJ)
    …promote cross-functional collaboration and stakeholder engagement. + Attract, grow, and lead a high-performing technical team focused on AI optimization, ... SaMD , etc.). + Strong experience in leading a technical team, and ability to work in a matrixed...is eligible to participate in the Company's long-term incentive program . Employees are eligible for the following time off… more
    J&J Family of Companies (11/19/25)
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  • Director of Software Architecture

    Insight Global (Indiana, PA)
    …effective software products As Director of SW Architecture - Cevego, you will lead the technical direction of the Cevego software development team globally. ... * Cross-Functional Collaboration: ○ Work with Radiology R&D leadership, Program Management Office, Data & Imaging teams, and external...a Medical Device (SiMD), Software as a Medical Device ( SaMD ), and AI applications. Acting as a technical… more
    Insight Global (11/27/25)
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  • Principal AI/ML Engineer

    Abbott (Santa Clara, CA)
    …within the Medical Devices Digital Solutions organization. In this role, you will lead the technical execution of Abbott's Medical Devices Digital (MDD) AI ... high employer contribution . Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to… more
    Abbott (11/25/25)
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