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Goleta

    Manager of Biomedical Engineering - Goleta, United States - True Digital Surgery

    True Digital Surgery
    True Digital Surgery Goleta, United States

    3 days ago

    Default job background
    Upper Management / Consulting
    Description
    ABOUT US
    True Digital Surgery is a World Leader in Computer-Guided Microsurgery. We combine 3D visualization and guidance software applications focused on improving accuracy, efficiency and outcomes for surgeons and patients. Our medical imaging and guidance system employs advanced real-time 3D graphic capabilities and proprietary software that is sold to surgeons and hospitals all over the world.

    SUMMARY
    The Manager of Biomedical Engineering directs and oversees the biomedical engineering function and team in understanding user needs, translating needs into design requirements, guides cross functional teams to evaluate risk, manage testing and validating the design. Ensures all biomedical engineering projects, initiatives, and processes are in conformance with organization's established policies and objectives. Utilizes best practice engineering methods and provides expert technical guidance for engineering initiatives. The Biomedical Engineering Manager will also analyze user and technical requirements to create and improve the efficacy, efficiency, and reliability of electromechanical devices. Will work collaboratively with cross functional teams: Sales, Marketing, Engineering, Quality, Regulatory, Operations, Customer Service and Program Management.

    SALARY AND PAY TRANSPARENCY
    Salary range for this position is between $120,000 and $153,000. Base pay is dependent upon many factors, such as: training, transferable skills, work experience, education, business needs and market demands. The base pay range is subject to change and may be modified in the future. This role may also be eligible for bonus, equity, and all applicable company benefits.
    The salary range and/or hourly pay rate listed is a good faith determination of potential base compensation that may be offered to a successful applicant for this position at the time of this job posting and may be modified in the future.

    ESSENTIAL DUTIES AND RESPONSIBILITIES
    Include the following. Other duties may be assigned.
    • Develop, lead, and manage the biomedical engineering group.
    • Provide input to the design process by providing clinical subject matter expertise in the use and application of our products in the fields of neuro, spine, and reconstruction surgery.
    • Ownership of key documents and processes in the design history file including, but not limited to, requirements, risk management, usability/human factors, design verification and validation.
    • Implement improvements to design controls processes to promote documents that meet changing regulatory expectations and overall business efficiency.
    • Contribute to regulatory submission efforts with FDA, CE for market clearance.
    • Lead, plan and execute assigned engineering projects according to project schedules
    • Create and maintain design documentation, such as descriptions, flowcharts, diagrams, and release notes.
    • Work with project managers to ensure that projects are completed on time, and within budget.
    QUALIFICATIONS
    To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

    Education/Experience
    Mandatory
    • Typically requires a minimum 8-10 years' experience in medical device development with a bachelor's degree or 5-7 years' experience in medical device development with a Master's Degree in science/engineering from an accredited university, or equivalent work experience in medical device development.
    • Minimum of 2 years' experience supervising technical staff.
    Desirable
    • Experience being in the operating room (OR) supporting live surgeries as a design engineer, tech. support, service engineer, or sales representative. Knowing OR sterility protocols, medical equipment
    • Understanding basic image processing concepts and techniques
    • Skills for mathematically modelling and characterizing systems
    • Basic knowledge of the human's body anatomy and physiology
    • A working knowledge of engineering design tools (i.e., schematic layout, PCB design, or CAD/CAM software). Hands-on background in operation and use of standard test equipment; oscilloscopes, digital multimeters, frequency generators, calipers etc. Ability to troubleshoot and analyze electronics.
    • Knowledge of different medical imaging modes such as optical microscopy, intraoperative fluorescence, X-rays, CT scans, MRI, OCT, etc.
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