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

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.

The Postdoctoral Researcher will help design and conduct research within a specified field while
receiving advanced training from a designated Principal Investigator to enhance professional
skills and research independence needed for pursuit of a career. The specific area of research in
which the trainee is mentored is determined by the department and laboratory of the Postdoc.

PRIMARY RESPONSIBILITIES

  • 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.
  • Positions are temporary appointments as a research trainee. The initial appointment is
    for one year with renewal expected if progress is satisfactory and funds are available.

qualifications

MINIMUM

  • A doctoral degree or equivalent (Ph.D., M.D., ScD. etc.) in an appropriate field.
  • Excellent scientific writing ability and strong oral communication skills.
  • The ability to work effectively and collegially with colleagues.

ADDITIONAL AS SPECIFIED BY THE PRINCIPAL INVESTIGATOR

  • 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, Medical Physics or
    related field.
  • Research experience in image analytics and knowledge of human anatomy is preferred.
  • Working knowledge of artificial intelligence (AI) applications in medical imaging (highly
    preferred but not required).
  • Research experience in medical image analysis of different imaging modalities (CT, MRI,
    PET, ultrasound, etc.) is preferred.
  • Ability to work independently and in a multi-disciplinary team environment.
Apply Via Email

Human Resources Director

job description

This is a unique opportunity for the right candidate to help build the Human Resources infrastructure that will support QT Ultrasound and its growth. The Human Resources Director will be responsible for the overall administration, coordination and evaluation of human resources plans and programs. The right candidate will have experience developing processes and procedures from scratch. This person will need to be a hands-on, flexible leader, who is creative and able to execute projects with minimal staff. The position is directly accountable to Sr. Leaders and will be responsible for making recommendations for and creating events and programs that foster a positive company culture. The ideal candidate will have previous experience that includes responsibilities of an HR Business Partner, Recruiter and HR Generalist. Startup experience is preferred.

PRIMARY RESPONSIBILITIES

• Manage the full life cycle of employment process including recruitment, interview, onboarding, performance evaluations, and exit interviews.
• Oversee the maintenance of the company’s personnel files, company directory, organizational charts, and space planning chart.
• Conduct new employee orientations.
• Maintain the company’s employee handbook on policies and procedures.
• Work with Insperity on benefits, workers compensation, and other compliance matters.
• Oversee leave of absences and ensure compliance with FMLA/CFRA, PDL, and ADA requirements.
• Ensure compliance with state, local, and federal guidelines and policies to protect the business and its employees.
• Develop and implement the company’s performance review program including job analysis, job evaluation and compensation guidelines.
• Counsel and train managers on the interpretation and administration of Human Resource policies including employee relations.
• Coach managers in drafting performance improvement plans, review for compliance and approve.
• Develop and implement an internal training program.
• Design events and programs that promote and foster company culture.
• Partner with Sr. Leaders to ensure strategic HR goals, policies, and programs are aligned with business initiatives.
• Act as a contact and support for internal personnel and serve as the liaison with Insperity – our PEO.
• Perform special projects as assigned.

qualifications

• Bachelor’s degree.
• Minimum 7 years’ experience in Human Resource Management.
• Human resources certification a plus.
• Strong written and verbal communications skills.
• Strong interpersonal skills – ability to establish and maintain positive working relationships with managers, peers and outside partners.
• Comfortable working in the details while maintaining a sense of the big picture.
• Adept at change and bringing colleagues along for the experience.

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

Mechanical Engineer

job description

We are seeking a Mechanical Engineer (with SolidWorks proficiency) to play a key role in the support of our 3D ultrasound breast imaging system and future ultrasound imaging systems.
The successful Mechanical Engineer (ME) will be responsible for providing high-level technical design of medical devices for new and current QT Ultrasound products. The ME will be a key team member for driving product functionality, reliability improvements, product serviceability, manufacturability, and support cost reduction.

PRIMARY RESPONSIBILITIES

  • Provide mechanical, electromechanical, and machine design in support of QT Ultrasound products.
  • Support ongoing change control board (CCB) with engineering change order (ECO) implementation according to Standard Operating Procedures (SOPs) & Department Operating Procedures (DOPs).
  • Support Manufacturing, Engineering, Procurement, and Service for design issues, improvements and cost reduction.
  • Update and create all Mechanical Engineering documentation via SolidWorks (PDM).
  • Identify areas in which product quality can be improved through analysis (i.e. structural, thermal, fluid flow).
  • Work with Electrical and Manufacturing Engineering for cable designs and system routing.
  • Assure system and product quality by designing test methods and testing finished product and system capabilities as well as confirming fabrication, assembly, and installation process.
  • Design motion control mechanical components.

qualifications

  • BS or higher degree in Mechanical Engineering.
  • Minimum 5 years of experience working as a Mechanical Engineer.
  • 2 + years of experience in technical writing/presentations preferred.
  • 3 + years of experience supporting FDA regulated products in the medical imaging capital equipment industry is preferred.
  • Mechanism design experience.
  • Knowledge of medical device equipment and experience supporting ultrasound medical devices or other medical imaging capital equipment is a plus.
  • Knowledge of electrical wiring and connections preferred.
  • 3 + years of SolidWorks experience.
  • Knowledge of Product Data Management (PDM) and Enterprise Resource Planning (ERP) preferred.
  • Must be a self-starter and capable of working effectively with little direct supervision and the ability to work effectively in a cross-functional team environment.
  • Ability to design, organize, plan, and deliver technical presentations as required.
  • Must possess good oral/written communication skills and positive interpersonal 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