About Paradromics
We are building a direct data interface with the brain to provide technology solutions to unmet medical challenges. A revolutionary leap beyond today’s research-grade brain computer interfaces (BCI), our Connexus® Direct Data Interface (DDI) collects neural signals at an industry-leading high data-rate and is designed for long-term daily use. Our first clinical application will enable severely motor-impaired people to communicate and independently use a computer, translating their neural signals into synthesized speech, text, and cursor control. We will continue to expand the capabilities of our massively scalable platform to support a pipeline of future applications that could benefit millions.
The Role
The Test Engineer will be responsible for planning and executing Internal testing as prescribed through Research and Development (R&D) needs and the Design Control Process efforts. This includes basic characterization testing and broader Verification/Validation (V&V) testing with a primary focus on implantable active electronic devices and neural implant testing. The position will incorporate all testing activities (including documentation of test protocols and test reports, and test execution) under the guidance of the Clinical, Quality and Regulatory team at Paradromics and in close collaboration with R&D, Manufacturing, and other departments as needed.
This position is instrumental in supporting the company’s continued growth and future success, and requires an individual with a “can-do,” self-starter attitude who is excited about working collaboratively and diving into hands-on, detailed testing work. This position is based on-site in Austin, Texas and will have less than 5% travel.
Responsibilities
- Lead Internal testing execution efforts as prescribed through R&D needs and the design control process, including characterization testing and V&V testing. This testing includes, but is not limited to, Hardware, Electrical and Accelerated/Real-time aging.
- Overall V&V test planning and drafting documents that are needed for the design control process such as Design Phase reviews and submission documents to the FDA.
- Develop Test Protocols and Test Reports on testing relating to the design control process or R&D related activities.
- Co-ordinate with External Vendors or labs that might be involved in V&V or other necessary testing.
- Function as a core team member on both software and hardware components, including active implantable devices, neural implants, and non-implantable system components, to support the design control process, test planning/execution, and documentation. This will also include supporting change control and change impact assessments.
- Assist with development of US FDA submission including Q-Subs, IDE, and PMA specifically regarding testing and test results.
- Creation of SOPs, work instructions, and other quality system elements, including development of best practices and workflows to efficiently manage the work.
- Reviewing guidance documents, PMA Summaries, regulatory standards and MAUDE database for background research and supporting knowledge to incorporate into testing methods.
Required Education
- Master’s degree in an Engineering, Science, or technical field.
Required Qualifications
- 3+ years’ experience in neural implants, and/or brain-computer interfaces.
- 3+ years’ experience relating to medical device development and/or testing activities.
- Experience with medical device quality standards and regulations relating to active implantable devices and neural implants. Recent experiences and real-time knowledge of FDA guidance and other applicable standards is highly desired.
- Experience working with and understanding the Quality Management System and familiarity with Title 21 CFR Part 820 and ISO 13485.
- Experience using optical imaging methods for visual inspection and dimensional verification.
- Experience using Electrical Functioning Testing equipment and familiarity with functioning testing needed for medical devices (e.g., electrode impedance spectroscopy, stimulation-stability, cyclic voltammetry, leakage current measurements).
- Experience as a core team member with hands-on responsibilities developing and implementing Testing strategies.
- The desire to develop creative solutions to complex problems that meet regulatory/quality requirements and business needs, while sharing knowledge and building consensus amongst stakeholders.
- The desire to thrive in a team environment with a diverse group of people, where individual contributions are highly valued.
- The desire for continuous learning and improvement.
- Excellent communication skills both orally and in written form with a desire for in-person communication. This includes experience leading meetings, projects, and presentations to small and large audiences.
- Excellent organizational skills and the ability to manage competing priorities and plan accordingly.
- Proficient skills in statistical data analysis.
- Proficient skills with Microsoft Office Suite, Google G-Suite and other PC based systems.
- Proficient skills using MATLAB, Python, AutoCAD, SolidWorks, LabVIEW, Simulink, COMSOL.
- Familiarity and experience with microfabrication processes and detailed knowledge of insulator deposition on Neural Implants (e.g., PECVD, CVD, ALD).
Preferred Qualifications
- Experience working directly in the brain-computer interface space or deep brain stimulation.
- Advanced knowledge on testing methods, such as accelerated aging of intracortical or peripheral arrays including microwire arrays.
- Advanced knowledge of stimulation-based methods pertaining to neural implants.
- Experience working on designing and implementing medical device interfacing leads (e.g., DBS like extension cables).
- Experience working on bonding (e.g., gold diffusion bonding) for medical device components.
- Experience working with hermetic feedthroughs, with a deep knowledge of feedthroughs bonding.
- Experience working through quality-based manufacturing processes, which are required for medical devices.
- Experience working on Electrical Safety or EMC testing with familiarity of testing required for medical devices.
- Experience with risk assessments (FMEAs).
- Experience with animal surgeries and subsequent failure mode analysis for neural implants.
Paradromics is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, or national origin.