Test Engineer - Quality

About Paradromics

Brain-related illness is one of the last great frontiers in medicine, not because the brain is unknowable, but because it has been inaccessible. Paradromics is building a brain-computer interface (BCI) platform that records brain activity at the highest possible resolution: the individual neuron. AI algorithms then decode this massive amount of brain-data, enabling the seamless translation of thought into treatments. 

Our first clinical application, the Connexus® BCI, will help people who are unable to speak, due to ALS, spinal cord injuries and stroke, to communicate independently through digital devices. However, the capabilities of our BCI platform go far beyond our first application. With the brain in direct communication with digital devices, we can leverage technology to transform how we treat conditions ranging from sensory and motor deficits to untreatable mental illness.

The Role

Over the next 12–18 months, this person will develop and execute robust, right-sized test plans and documentation that support both device manufacturing and design verification for regulatory submissions. This role ensures that test methods are accurate, repeatable, and defensible under regulatory scrutiny, while aligning testing rigor with the maturity of our active implantable BCI system. The ideal candidate brings hands-on experience across hardware, electrical, and software testing environments and thrives in a fast-paced, evolving startup setting.

Responsibilities

• Provide subject matter expertise and hands-on execution of Test Method Validation (TMV), including measurement system analysis (Gage R&R).
• Independently create inspection plans and coordinate program development for acceptance criteria.
• Plan, execute, and document verification protocols and reports supporting design changes in accordance with applicable regulations and standards.
• Coordinate and conduct program development activities for acceptance criteria and associated test methods.
• Plan and, as appropriate, conduct validation activities for newly developed programs and test methods.
• Support cross-functional teams in aligning testing activities with design controls, regulatory strategy, and manufacturing readiness.

Required Education

• Bachelor’s degree in Engineering (or minimum 4 years of relevant engineering experience in lieu of degree).

Required Qualifications

• Minimum 3 years of experience in a quality or engineering function within a medical device company.
• Minimum 2 years of experience creating and executing TMV protocols and reports.
• Minimum 2 years of experience conducting design verification and validation (V&V) activities.
• Experience with inspection and measurement equipment.
• Proficiency in statistical data analysis (e.g., Six Sigma methodologies).
• Ability to respond rapidly to change and pursue practical, novel solutions in a dynamic environment.

Preferred Qualifications

• Experience in a startup or early-stage medical device company.
• General understanding of electrical engineering principles.
• Experience working with or testing software components (Python familiarity preferred).
• Experience supporting regulatory submissions for active implantable medical devices.

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.