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. 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.
Requirements
- 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.
- Experience with injection molding, laser welding, CNC machining, sheet metal, and cleaning processes.
- Exposure to electronics integration for implantables (power, telemetry).
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.
Other
- Reporting to the Senior Director of Product Development
- 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.
- Demonstrated ability to mentor junior engineers and embed best practices across team workflows.
- Prior success scaling engineering processes at small or startup medtech companies.
- Experience leading or supporting regulatory submissions.
- Supplier collaboration experience.
