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    Senior Product Development Engineer - San Diego, United States - Tempo Therapeutics

    Tempo Therapeutics
    Tempo Therapeutics San Diego, United States

    3 weeks ago

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    Description

    At Tempo Therapeutics, we are pioneering a new era in tissue engineering and regenerative medicine with our cutting edge Microporous-Annealed-Particle (MAP) technology platform. Our team is developing next generation biomaterials to build precision scaffolds for use in surgical reconstruction, organ regeneration, and even vaccine technology. Our mission is to harness the power of immunomodulation and use material science to transform the landscape of medical technology.

    This is a unique opportunity to work in a fast-paced and challenging environment, while being an integral part of a team that is developing material science technology shaping the future of medicine. Our team is driven by the goal of changing patient lives for the better, and the successful candidate will share that driving force.

    Job Summary:

    The Senior Product Development Engineer works within Research & Development and is responsible for leading the device design efforts and development of manufacturing processes for medical devices to be transferred to CMO for manufacturing according to cGMP. Manages and executes process technology transfer, process validations, PFMEA, and CAPA's from clinical to commercial production stages according to ISO standards and FDA regulations. Manages external vendors and service partners to ensure compliance, timelines, and budget are maintained. Supports development of innovative final product presentation solutions for delivery of novel biomaterial products.

    Responsibilities:

    Position will perform the following in a leading role:

    -Manage medical device design control process per ISO 13485 and 21 CFR 820

    -Draft and maintain SOP's

    -Develop and execute process validations

    -Develop and execute PFMEA

    -Support vendor audits

    -Maintain and help develop device master file (DMF) and design history file (DHF)

    -Supports ongoing application of risk management per ISO 14971

    -Transfer manufacturing process to CMO

    • CMO's to ensure compliance for clinical and commercial manufacturing programs
    • routine laboratory housekeeping, support inventory management, shipping, receiving, reconciliation activities.
    • duties as assigned/needed
    • to Director of Research and Development

    Qualifications:

    Bachelor's degree in chemistry or other life science related field

    10+ years' experience working within a quality system, direct experience working within cGMP to support full product manufacturing lifecycle from pre-clinical, clinical, and commercial stages. Experience interacting with FDA to support inspections desired.

    Extensive knowledge and experience in (must have):

    -Good manufacturing practices per 21 CFR 211

    -Process validation

    -PFMEA

    -Manufacturing product lifecycle management

    -Design controls via 21 CFR 820 and ISO 13485

    -ISO 14971 Application of Risk Management

    -Equipment validation

    -MS Suite

    Additional knowledge and experience in (pluses):

    -Aseptic processing and validations

    -Fill and finish

    -Complex formulations

    -Tangential flow filtration (flat sheet and hollow fiber)

    -Sterile filtration

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