Manager, Device Development and Manufacturing - Lexington - Kiniksa Pharmaceuticals

    Kiniksa Pharmaceuticals
    Kiniksa Pharmaceuticals Lexington

    3 days ago

    Description

    Kiniksa is seeking a highly motivated Manager, Device Development and Manufacturing to join our Drug Product Development team in Lexington, MA. Reporting to the Director, Device Development and Manufacturing, this individual will play a key role in developing Kiniksa's drug-device combination products.
    This role is based in our Lexington, MA office. Our office-based employees follow a hybrid schedule of 4 days in the office, and 1 day remote.
    Responsibilities (including, but not limited to):

    • Manage combination product design history file (DHF) functioning as SME on design control and risk management.
    • Manage external vendors and partners (CMDOs and device testing labs) to advance project milestones
    • Develop, manage, execute, and support human factors studies. Conduct use-related risk assessments
    • Execute design verification and validation
    • Conduct impact assessments for Change Control, including DHF/RMF assessments
    • Author and review of regulatory submissions and responses
    • Assist in platform device selection and packaging design for new programs by performing feasibility tests
    • Summarize and communicate project updates to stakeholders
    Qualifications and Experience:
    • Requires a Bachelor's degree in mechanical or biomedical engineering related field of study with 6+ years of relevant industry experience; or Master's degree (preferred) with 4+ years of relevant industry experience
    • Knowledge of applicable regulations/standards, such as 21 CFR Part 820/QMSR, ISO 13485, ISO 14971, IEC 62366, Part 4, etc. with a focus on Design Controls and Risk Management
    • Previous experience with combination products is required, such as autoinjectors, co-packed kits, pre-filled syringes, inhalers
    • Ability to manage multiple priorities and work with ambiguity
    • Strong commitment to compliance and ethical standards
    • Ability to travel up to 5%
    • Salary is commensurate with experience
    • Kiniksa Benefits Summary - USA
    The pay range for this position is $134,000 - $152,000. Compensation is subject to change commensurate with industry standards and the candidate's relevant experience and qualifications.

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