Staff Product Development Engineer

Staff Product Development Engineer 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 We are seeking a Staff Product Development Engineer to join our Product Development team in Austin, TX.
• Reporting to the Senior Director of Product Development, this individual will be a key contributor in maturing our Connexus system from early feasibility through clinical readiness and launch.
• This role combines strong hands-on mechanical engineering expertise with the ability to mentor junior engineers, instill medical device best practices, and ensure designs meet the highest regulatory and quality standards.
• Responsibilities Serve as a senior mechanical engineering contributor and provide SolidWorks technical mentorship for junior engineers.
• Lead refinement of the Connexus system through design maturity, formal verification / validation (V&V), and into Pivotal and commercial launch.
• Consult with and review designs from the advanced R&D team, guiding them to consider regulatory and quality constraints early in the design process.
• Establish, implement, and embed medical device best practices across the engineering team.
• Ensure all designs, documentation, and processes align with FDA, ISO, and industry standards.
• Required Education Bachelor’s or Master’s degree in Mechanical Engineering or related technical discipline.
• Required Qualifications Minimum 8 years of medical device development experience, preferably in the active implantables space.
• Proven experience refining medical devices through V&V and clinical readiness, including DFM, FMEA, TM development, TMV, IQ / OQ / PQ / PPQ.
• Strong foundation in medical device best practices, including design controls, ISO 13485, ISO 14971, and DHF management.
• Advanced SolidWorks expertise (CAD, assemblies, GD&T).
• Hands-on experience with troubleshooting and maturing early-stage medical device designs.
• Demonstrated ability to mentor junior engineers and embed best practices across team workflows.
• Preferred Qualifications Experience with injection molding, laser welding, CNC machining, sheet metal, and cleaning processes.
• Prior success scaling engineering processes at small or startup medtech companies.
• Exposure to electronics integration for implantables (power, telemetry).
• Experience leading or supporting regulatory submissions.
• Supplier collaboration experience.
• 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.
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