Join our team

QT Ultrasound is a cohort of exceptional talent from a variety of professional backgrounds. A collaboration of clinicians, engineers and scientists – it is the quintessential biomedical engineering and clinical trials company. If you want to join the best and brightest with a mission to transform the diagnostic assessment of breast health, we encourage you to apply.

QT Ultrasound is a cohort of exceptional talent from a variety of professional backgrounds. A collaboration of clinicians, engineers and scientists – it is the quintessential biomedical engineering and clinical trials company. If you want to join the best and brightest with a mission to transform the diagnostic assessment of breast health, we encourage you to apply.

Current Openings

Senior Financial Analyst

job description

The Senior Financial Analyst is responsible for carrying out the financial planning and analysis (FP&A) responsibilities for a revolutionary medical device Company. He/she will act as a contact and support for internal personnel and external partners in a fast-paced, growth-oriented, start-up environment.

PRIMARY RESPONSIBILITIES

  • Create annual and quarterly operating plans for multiple divisions and lines of business working closely with various department heads
  • Prepare the monthly financial statement packages and various reports for Management and Board meetings.
    Compare actuals to budgets and provide variance explanations
  • Develop financial models and analyses to support strategic initiatives
  • Prepare multi-year financial projections
  • Prepare presentations of key financial trends to present to management
  • Deliver well thought out ad hoc reporting and analysis as business grows and pursues new lines of business
  • Perform special projects as assigned
  • Other activities as directed

qualifications

  • Bachelor’s degree; MBA a plus
  • Minimum three years’ experience with financial modeling and FP&A
  • Highly competent computer proficiency and familiarity with Microsoft Office (Word, Excel, Outlook, PowerPoint)
  • Expert in Excel in order to create and manipulate complex financial models
  • Must be a perfectionist by nature, with no tolerance for financial sloppiness
  • Strong written and verbal communication skills
  • Strong analytical and presentation skills
  • Strong interpersonal skills – ability to establish and maintain positive working relationships with executives, managers, peers and multiple outside partners
  • A ‘can do’ approach to work, self-motivated and able to take initiative on projects
  • Must be a master of organization with a keen attention to detail and ability to juggle multiple priorities while adhering to monthly deadlines
Apply Via Email

Controller

job description

The Controller is responsible for the day-to-day accounting activities of the Accounting/Finance Department in a fast-paced, growth-oriented, start-up environment. He/she will act as a contact and support for internal personnel, external vendors and customers, and other business partners.

PRIMARY RESPONSIBILITIES

  • Close the books monthly, timely and accurately
  • Month-end close duties, including but not limited to:
    • Review/prepare bank reconciliations
    • Review/prepare various account reconciliations including prepaids, accruals, inter-company accounts and credit card accounts
    • Review/prepare various journal entries
    • Perform revenue recognition entries
    • Prepare consolidation schedules
  • Process payroll bi-weekly and ensure proper recording in ERP system
  • Maintain the ERP database:
    • Chart of Accounts
    • Vendor/Customer Setup
    • Periods closed timely
  • Work with external auditors to prepare annual financial statements and supporting schedules
  • Respond to inquiries from executive management and department heads regarding financial results and special reporting requests
  • Perform various administrative tasks related to organizing and integrating new legal entities and lines of business
  • Work with sales and use tax consultants to timely file tax returns in multiple states
  • Maintain records of insurance policies and work with brokers during annual renewal and throughout the year as the business grows and evolves
  • Perform special accounting projects as assigned
  • Other activities as directed

 

qualifications

  • Bachelor’s degree in Accounting or related field. CPA preferred
  • Minimum five years’ experience in a managerial accounting role
  • Experience with NetSuite a plus
  • Experience with Concur for processing T&E a plus
  • Experience working in a manufacturing environment a plus
  • Highly competent computer proficiency and familiarity with Microsoft Office (Word, Excel, Outlook)
  • Must be a perfectionist by nature, with no tolerance for financial sloppiness
  • Strong written and verbal communication skills
  • Strong interpersonal skills – ability to establish and maintain positive working relationships with managers, peers and multiple outside partners
  • A ‘can do’ approach to work, self-motivated and able to take initiative on projects
  • Must be a master of organization with a keen attention to detail and ability to juggle multiple priorities while adhering to monthly deadlines
Apply Via Email

Postdoctoral Researcher - Image Science/Image Physics

job description

We have an opening for a qualified postdoctoral research fellow at QT Ultrasound in Novato, CA. You will join our clinical group in solving challenging and high-impact preclinical and clinical research problems in breast imaging.

PRIMARY RESPONSIBILITIES

  • Development and application of imaging analytics and AI methods to analysis of transmission ultrasound images of the breast to enhance our understanding of breast pathologies as manifested in transmission ultrasound tomographic imaging. Machine learning approaches will be used to discover and link imaging biomarkers across multiple scales and imaging modalities.
  • Design and implement informatics solutions to analyze clinical and pre-clinical data focused on, but not limited to medical images.
  • Work in close collaboration with research and software scientists to integrate predictive and decision support models into QT’s production software.
  • Design and evaluate experiments, develop new ideas that promote current research, and prepare and publish scientific manuscripts under the direction of the Principal Investigator.
  • May be responsible for operation of specific equipment.
  • May teach techniques to others, train, and supervise research staff.
  • Keep up to date with technology trends while generating concepts and exploring their feasibility to support the current products.
  • The initial appointment is for one year with renewal expected if progress is satisfactory and funds are available.

qualifications

• The successful candidate will be expected to publish significant research findings and
must have excellent verbal and written English communication skills.
• Ph.D. or equivalent doctoral degree in biomedical engineering, computer sciences, medical physics or related field.
• Research experience in image analytics and knowledge of human anatomy is preferred.
• Expert knowledge of artificial intelligence (AI) applications in medical imaging is highly preferred.
• Research experience in medical image analysis of different imaging modalities (CT, MRI, PET, ultrasound, etc.) is highly preferred.
• Ability to work independently and in a multi-disciplinary team environment.

Apply Via Email

Manager, Clinical Operations

job description

The Manager of Clinical Operations will ensure clinical trial projects are properly resourced, managed, and executed. We are seeking a motivated individual who leads and steps in as a team player.

PRIMARY RESPONSIBILITIES

  • Lead and develop the clinical team
  • Oversee daily clinical operations
  • Contribute to the development of study documentation
  • Select required clinical partners, vendors, and laboratories for the conduct of clinical trials
  • Oversee coordination and execution of multi-day clinical trial radiologist reader studies
  • Drive trial enrollment and timelines
  • Provide and/or facilitate training to the clinical team according to protocol
  • Develop and manage trial budgets and timelines
  • Proactively identify issues and/or risks with clinical trials and provide solutions
  • Travel to sites and meetings as necessary

qualifications

  • Bachelor’s degree in a healthcare or business management field
  • Master’s/Ph.D. preferred
  • 5+ years’ experience in managing a diverse team with multiple functional and collaborating silos of focused expertise
  • 5+ years’ experience planning, executing, and managing clinical trials, vendors, and CROs
  • 5+ years’ medical device industry experience (strong preference for specific experience in medical imaging)
  • Solid understanding of site qualification, selection, management and enrollment
  • Working knowledge of RIS, PACS, and eCRF systems highly preferred
  • Background in scientific writing preferred
  • MS Office proficiency
  • Excellent verbal and written communication skills
Apply Via Email

R & D Engineer, Electrical

job description

Supports hardware and system product development by researching, designing, prototyping and testing solutions for exploratory and product use.

ESSENTIAL DUTIES AND RESPONSIBILITIES

  • Code Verilog, Simulate, Test and Debug FPGAs using the latest tools.
  • Designs, bread-boards prototypes, and tests board-level electronic circuits for product development, testing and research use, utilizing off-the-shelf integrated circuits, analog design, digital design, micro- controllers.
  • Prepares schematic capture and implements breadboards for circuit prototypes.
  • Researches, evaluates, qualifies and purchases components for circuit assembly; maintains inventory for all modules and components.
  • Supports all technology development efforts in ultrasound scanner design characterization and other component qualification.
  • Prepares test protocols, executes and generates test reports.
  • Manages and maintains electronic laboratory setup and equipment.
  • Interfaces with vendors, manufacturing engineers and support personnel.

EXPERIENCE

  • Requires a minimum of 5 years’ experience in design, development and testing of electronic circuits.

qualifications

  • Experience with CPLD/FPGA programmable logic development primarily Altera devices.
  • Experience with design capture tools (Orcad, PADS and Spice or equivalent tools).
  • Ability to analyze, design and breadboard circuits using analog and digital components.
  • Ability to use oscilloscopes, spectrum analyzers, network analyzers, logic analyzers, and drive custom-made instruments.
  • Proficiency in signals and systems theory.
  • Familiarity with designing for EMI compliance and testing.
  • Ability to build electronics circuits and fixture.
  • Ability to write test protocols, work instructions and reports.
  • Must possess excellent communication and interpersonal skills with the ability to work in a multi- disciplinary, fast-paced start-up environment.
  • Must possess good problem-solving skills.
  • Understanding of FDA/ISO requirements for Production and Process Control.

EDUCATION

  • Four-year Bachelor’s degree in Electrical Engineering.
Apply Via Email

Software Quality Engineer

job description

The Software Quality Engineer will verify/validate software for complex ultrasound imaging devices that interact with patients. They will develop automation tests and software quality documentation for desktop image viewing applications.

PRIMARY RESPONSIBILITIES

  • Perform system-level software verification on embedded systems, desktop applications and supporting software
  • Collaborate with members of R&D and Manufacturing to define and implement testing strategies necessary for devices and their supporting applications and infrastructure
  • Develop and execute written software verification protocols, document and report test results per our regulatory procedures
  • Work with the development team on failure/root-cause analysis
  • Develop and validate automation tests for the scanner device, image viewer and/or supporting software applications
  • Review requirements and design documentations to ensure technical accuracy as
    well as testability; act as a quality advocate throughout the development cycle
  • Prepare software quality documentation as required

qualifications

  • BS in computer science, electrical engineering, information technology or equivalent
  • 5+ years of experience as a software tester, integrator or developer
  • Sufficient hardware and software experience to build and configure software systems, understand the subsystems and their interactions in the overall system
  • Experience developing software verification and validation strategies, plans and protocols
  • Proficient in Linux, shell scripting, Python, C/C++
  • Working knowledge of Jenkins, Git, CMake and Atlassian tools (JIRA, Confluence, Bitbucket)
  • Strong working knowledge of software engineering best practices
  • Excellent communications, time management and documentation skills
  • A high level of creativity and self-motivation

DESIRED QUALIFICATIONS

  • Medical device and/or medical imaging experience
  • Working knowledge of IEC 62304, DICOM, HL7
  • TestRail experience
  • Experience bringing new products to market
Apply Via Email

Regulatory Affairs Manager

job description

The regulatory affairs manager functions as an interface between QT Ultrasound and governmental regulatory agencies to assure compliance with applicable laws and regulations that apply to the development, clearance or approval, marketing, promotion and post-market surveillance of QT Ultrasound medical devices in the US.

The regulatory affairs manager prepares and oversees documentation, information and analysis for regulatory submissions and supporting files. This position includes involvement in strategic planning and implementation of regulatory pathways and submissions for market clearance.

PRIMARY RESPONSIBILITIES

  • Assist in the identification, development and implementation of appropriate regulatory plans, including submission strategies to support product development and approval of our medical device products.
  • Develop, author and prepare regulatory submission packages to bring new or modified products to market.
  • Represent Regulatory Affairs during FDA inspections or other government agency audits as required and respond to regulatory inquiries.
  • Participate in cross-functional development teams, providing regulatory input, guidance and regulatory standard identification, to facilitate effective and efficient regulatory determinations and execution.
  • Participate in risk analysis efforts in accordance with ISO 14971, providing input and regulatory perspective regarding risk assessment.
  • Review controlled documents for determination of regulatory actions. Maintain and improve practices, standard operating procedures (SOPs), metrics, work instructions, reports and forms keeping with current regulatory requirements and best practices.
  • Manage reporting processes for regulatory complaint system. Ensure reporting compliance through timely, appropriate and accurate assessments regarding medical device reports (MDRs), adverse events, and field actions (recalls, corrections, removals).
  • Provide training to QT Ultrasound employees on regulatory practices and requirements as needed.
  • Provide regulatory support to the clinical, quality and engineering departments.
  • Work collaboratively on project and product teams to provide early guidance, design control reviews, and Regulatory Strategy.
  • Provide regulatory support to the compliance officer in maintaining and strengthening corporate compliance policies.
  • Support marketing, new product development and operations in regulatory assessment of proposed changes. Perform and document regulatory assessments for modifications to existing devices.
  • Interface and coordinate with FDA and State regulatory agencies on submissions, approvals, and inspections.
  • Monitor, interpret and respond to existing and/or new regulatory requirements as they relate to company products and procedures. Communicate this to appropriate personnel.
  • Prepare and update product listings and establishment registration.
  • Promotional Material Review: Provide support to currently marketed products, e.g., review labeling, promotional material, product changes and documentation for compliance and for changes requiring regulatory agency approval
  • Review/assess risk and analyze hazards with new designs and proposed design changes.
  • Perform other related duties and special projects as required by management.

qualifications

  • Bachelor of Science Degree in technical, engineering, and/or scientific discipline. Professional designations are not required but training and certificates in regulatory affairs are a plus.
  • Minimum 5-7 years in a regulated industry with applied experience/knowledge in regulatory.
  • Ability to execute assignments independently as assigned. Must possess strong organizational skills. Must possess strong written and verbal communication skills. Must possess demonstrated ability to handle multiple priorities simultaneously.
  • Knowledge of 21 CFR 820, ISO 13485, and ISO 14971 (desired)

 

Apply Via Email

Quality Manager

job description

The Quality Manager has the primary responsibility of establishing and maintaining compliance of QT Ultrasound processes and products to the US Quality Systems Regulations, ISO 13485 and Medical Device Regulation, as well as contributing to the development & implementation of commercialization of products in compliance with applicable regulations and standards. The Quality Manager will manage and maintain compliance for quality systems, including: supplier control, equipment control, nonconformance control, CAPA, document control, training, production and acceptance activities

PRIMARY RESPONSIBILITIES

  • Ensure compliance with Quality System Regulations and associated requirements
  • Execute QT Ultrasound’s Management Review process with support from senior management to identify metrics, trend analysis and actions necessary to improve the quality management system
  • Provide guidance for Design Control, Production and Servicing documentation to establish and maintain Design History Files and Device History Records
  • Work closely with other departments such as Regulatory, Clinical, Engineering, Operation and Service to achieve company goals
  • Ensure compliance to domestic (i.e., FDA, FDB) regulations & international regulations as determined by company strategy and regions where the device is distributed
  • Manage CAPA, NCRs and Supplier Files
  • Manage document control
  • Manage the compliance of training activities and assure employee training remains up to date
  • Responsible for all audit activities, including audit preparedness
  • Support compliance audits by proposing corrections, corrective actions, and preventive actions, along with performing effectiveness verification as required

qualifications

  • Bachelor’s in Science or demonstrable relevant QA experience
  • 3 years’ experience in a QA/RA management role or equivalent
Apply Via Email

Incoming/In-process Inspector

job description

The successful resource will determine the quality level of parts or products at various stages of production by performing a wide range of inspection procedures. Having prior experience in medical device is needed as we need to adhere to the established Quality Systems standards in relation to FDA regulations.

PRIMARY RESPONSIBILITIES

  • Inspect incoming and in-process material used to manufacture, assemble, and test QT Ultrasound products, and their components.
  • Initiate inspection, First Article Reports (FA), nonconformance reports (NCRs), engineering change requests (ECRs), and other quality documents in support of the daily process.
  • Maintain inspection records according to Standard Operating Procedures (SOPs) at QT Ultrasound
  • Sustain and coordination of inspection equipment calibration and preventive maintenance program designed by the Quality Control department.
  • Adhere to and ensure compliance with Quality System SOPs, work instructions, drawings, Good Manufacturing Practices (GMPs), Good Documentation Practices (GDPs).

qualifications

Experience

Requires a minimum of 3 years of experience as an incoming and in-process inspection

Knowledge/Skills/Abilities

  • Must be able to comprehend engineering drawings and have general knowledge of GD&T standards
  • Experience with mechanical measuring equipment such as calipers, micrometers, height gages, dial indicators, etc.
  • Ability to use oscilloscopes, multimeters, spectrum analyzers, network analyzers, logic analyzers, and drive custom-made instruments is a plus
  • Ability to write test protocols, work instructions and
  • Must possess excellent communication and interpersonal skills with the ability to work in a multi- disciplinary, fast-paced start-up environment.
  • Must possess good problem-solving
  • Understanding of FDA/ISO requirements for Production and Process

Education

AA or Trade school degree.  A Bachelor degree in mechanical engineering is a plus

Apply Via Email

Test Technician

job description

The Test Technician is responsible for performing the set-up, calibration, testing, and troubleshooting during the production of our ultrasound breast scanning system. Following established procedures, the Test Technician will complete final testing of automated 3D ultrasound breast scanners and may also perform subassembly tests. If required, the Test Technician is also responsible for troubleshooting any functional issues identified during testing and as required, prepares technical reports summarizing findings and recommends solutions to technical problems. May assist in the selection and set-up of specialized test equipment and the development of test procedures. This position is based at QT Ultrasound’s facility in Novato, California. Experience in the manufacture and/or testing of ultrasound medical devices or other medical imaging capital equipment is preferred.

PRIMARY RESPONSIBILITIES

  • Performs set-up of test equipment where required and completes all production calibration and tests of final product including system performance verification and acceptance
  • Performs in-depth troubleshooting of final product as required during final
  • Conducts testing in accordance with all written manufacturing and quality system procedures.
  • Accurately documents test results in reports and/or lot history
  • Ensures working areas are kept neat, clean, and
  • Meets all set productivity goals and follows all established safety
  • Assists in the development of new test
  • Identifies and communicates to team and management any failure
  • Ensures all equipment and tools used are maintained and

qualifications

  • Minimum 5+ years of experience in a manufacturing environment – medical devices preferred
  • AS in Electronic Engineering or equivalent military training and experience
  • Computer knowledge: Proficient with PC’s and office software applications such as Word and Excel. Experience working with Linux OS and MATLAB preferred
  • Ability to work independently and be detail-oriented
  • Experience working in an FDA regulated environment and knowledge of 21 CFR part 820 preferred
  • Experience working within an ESD protected environement
  • Excellent time-management, interpersonal, and communication skills
  • Listens well and retains instructions; accepts constructive feedback and provides solutions to challenges
  • Proficient in the use of basic test and measurement instruments such as HiPot tester, resistance meters, current leakage testers, ground impedance testers, multimeters.
  • Experience using custom robotic testers is an asset.
Apply Via Email