Topcon

  • Project Manager, Clinical R&D

    Requisition ID
    2019-3118
    Experience Level
    Manager
    Industry
    Medical
    Employment Status
    Regular Full-Time
    Location : Location
    US-NJ-Oakland
    Category
    Project Management
  • Overview

    Topcon is a comprehensive ophthalmic device manufacturer within the worldwide ophthalmic community. It introduced the world’s first commercial back-of-the-eye spectral domain (SD) and swept source (SS) optical coherence tomography (OCT) systems, which have driven innovation in eye-care.

    More recently, Topcon Healthcare Solutions was launched as a new strategic division whose primary objective is to create world-class software solutions for the eye-care industry and beyond. Our products enable the collection, storage, and visualization of a wide range of imaging and clinical data while providing quantitative and clinical analysis capabilities. Topcon’s software gives clinicians access to patient exam data captured from OCTs, Visual Fields, Fundus cameras, and other Topcon and third-party devices. We leverage Topcon’s image management software, where practitioners gain access to information stored in a central, cloud-based environment.

     

    We seek a highly motivated project manager to work creatively on both R&D and clinical projects with global impact contributing to cutting-edge ophthalmic medical device solutions and regulatory clearances. 

    Responsibilities

    • Management of projects by R&D and clinical staff and/or cross-functional teams covering the development, implementation, and validation of medical device imaging and quantitative software features.
    • Work with the internal R&D team to define project scope and create and manage project plans to achieve R&D goals.
    • Collaborate with clinicians, researchers, and developers to arrange and collect clinical data to facilitate and enable feature development.
    • Participate in regulatory clearance projects in a project management role, working as part of a broad cross-functional clinical/regulatory team.
    • Utilize sound judgment in assessing projects’ health; identifying, mitigating and resolving project issues and risks to achieve on-time and on-budget results.
    • Project management using software such as Wrike and Project, along with project management tools such as Gantt charts.  Generation of reports using same software.
    • Demonstrate strong interpersonal and communication skills including writing, presenting to, listening to, and facilitating project participants, stakeholders and management.
    • The ideal candidate will have prior experience in both clinical project management and R&D project management.

    Qualifications

    Education & Experience

    • MS or BS in relevant field.
    • 1 to 5 years industry experience preferred.

    Knowledge, Skills & Attributes

    • Project management experience in technical and clinical environments.
    • A sufficiently technical understanding and/or background, including general familiarity with image processing and device and software validation concepts, in order to be able manage feature development projects.
    • General familiarity with FDA clearance processes and requirements (especially for 510k) as well as aspects of Quality System Regulation (QSR) such as Design Controls.
    • Familiarity with SOPs and relevant FDA and ICH guidelines along with GCP, GMP, and GDP requirements (including any other relevant areas of GxP).
    • Familiarity with Wrike, Project, Gantt charts, Work Breakdown Structure (WBS) and/or other project management tools strongly preferred.
    • Self-starter and ability to work in a fast paced, start-up/entrepreneurial environment.
    • Strives to succeed when working as part of a dynamic team.
    • Ability to manage multiple projects at one time.
    • Familiarity with medical imaging and prior experience working in the medical device field a strong plus.
    • Rough knowledge of developing software algorithms and features, including machine learning/deep learning in image analysis a plus.
    • Experience with or knowledge of optical coherence tomography (OCT) imaging a plus.
    • Strong oral and communication skills required.
    • Must be a team player with a strong work ethic.

     

     

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