Staff Product Development Engineer en Paradromics, Inc.
Paradromics, Inc. · Austin, Estados Unidos De América · Onsite
- Senior
- Oficina en Austin
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
- 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.
