• Manager, Device Development

    Job Locations US-CA-San Diego
    ID
    2019-1141
    Category
    Manufacturing
    Type
    Full-Time
  • Overview

    The Manager of Device Development supports technical development and commercialization efforts for Xeris’ device and combination product programs. The Manager is responsible for supporting development of products according to Xeris’ Design Controls and product development processes. As part of a cross-functional team, project work will include all aspects of product development, design input, design output, specification development, test method development, design verification/validation, process validation, design transfer, as well as risk management. While Xeris uses contract development and manufacturing organizations (CDMOs), some of the work will be coordinated with internal departments. The Manager is also responsible for support in compiling the Device History File (DHF) and associated Regulatory submissions. 

    Responsibilities

    Support device operations at contract sites (CMO, etc.). Responsibilities include, but may not be limited to:

    • Support design and development activities for new and existing drug/device products to ensure they meet or exceed requirements and can be manufactured with the highest quality
    • Assist in determining the technical design criteria for each project
    • Support translation product requirements into specifications
    • Support design development in accordance with specifications
    • Evaluate and improve the robustness of new products through product launch
    • Support the production team for pre- and post- commercial manufacturing
    • Work in a cross-functional team environment to solve manufacturing-related issues
    • Work in compliance with approved quality standards
    • Manage development, manufacturing, and testing operations at contract sites
    • Adhere to CMC budgets
    • Support authoring device sections for combination Drug Product sections of the eCDT for INDs and NDAs

    Qualifications

    • Bachelor’s/Master’s degree in Biomedical or Mechanical Engineering, or similar discipline and 5 to 10 years of experience working with pharmaceuticals/biopharmaceuticals
    • A minimum of 3 to 5 years experience in a GMP pharmaceutical/biopharmaceutical environment
    • Considerable experience in device and combination product operations
    • Understanding of device regulations in support of FDA and EU submissions
    • Experience with engineering documentation and guidelines (i.e. ISO & ASTM)
    • Knowledge of device Quality Management Systems (i.e. 21CFR820 & ISO 13485)
    • Familiarity with cGMP principles and work environment
    • Must be results oriented and have demonstrated interpersonal and communication skills
    • Strong organization, prioritization, and time-management skills.
    • Proficient with use of Microsoft Word, PowerPoint, Outlook, and Excel and web-based software for various applications
    • Travel up to 35%
    • Position may require periodic evening and weekend work, as necessary to fulfill obligations. 

    Options

    Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.