Product Development Engineer

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.

Paradromics is seeking a Product Development Engineer to own the mechanical development of our next-generation implantable Internal Transceiver (IT). You will translate system needs into a robust mechanical architecture and mature product design, developing the requirements, verification methods, and manufacturing processes needed to take the IT from concept through design maturity and manufacturing readiness.

You will work closely with process engineering, test engineering, quality, regulatory, and external suppliers to develop both the product and the processes required to consistently build a complex implantable medical device. This is a highly cross-functional role requiring strong mechanical engineering fundamentals, hands-on problem solving, and the ability to independently drive technical challenges to resolution.

• →Own the mechanical architecture and detailed design of the next-generation implantable Internal Transceiver, including housing, internal packaging, interfaces, and critical mechanical components.
• →Develop clear, testable mechanical requirements and design inputs that define product performance, reliability, interfaces, and physical characteristics.
• →Translate system-level requirements and functional needs into mechanical architectures, specifications, acceptance criteria, and verification methods.
• →Develop and execute mechanical characterization and verification testing, including test methods, fixtures, protocols, data analysis, and technical conclusions.
• →Troubleshoot mechanical design and reliability issues through root-cause investigation, design changes, and confirmation testing.
• →Develop, optimize, and troubleshoot manufacturing processes required to reliably and repeatably produce the IT mechanical assembly.
• →Partner with Manufacturing, Quality, Reliability, and suppliers to develop and mature product and manufacturing processes.
• →Support design control activities, including requirements, risk management, verification, and design history file (DHF) documentation.
• →Drive technical problems independently from initial investigation through resolution and design maturity.
• →Execute or lead additional engineering tasks, secondary design initiatives, and cross-functional support as needed. 

• Bachelor's degree in Mechanical Engineering or a related engineering discipline.

• Proven experience developing complex mechanical medical devices or assemblies from concept through design maturity.
• Strong mechanical engineering fundamentals, including GD&T, tolerance analysis, materials, mechanical interfaces, and design for manufacturability (DFM).
• Advanced SolidWorks/CAD skills, including complex assemblies and detailed engineering drawings.
• Experience developing clear, testable engineering requirements and design inputs from higher-level system requirements or functional needs.
• Experience developing and executing mechanical testing, including test method development, fixture design, test protocols, data analysis, and technical conclusions.
• Demonstrated ability to troubleshoot mechanical designs using testing, data, and root-cause analysis.
• Experience developing, optimizing, and troubleshooting manufacturing processes for mechanically complex products.
• Experience working within medical device design controls, including requirements, risk management, verification, and DHF documentation.
• Strong ability to independently own technical problems and drive them to resolution across engineering and manufacturing functions.

• Experience with active implantable medical devices, such as pacemakers, ICDs, or neurostimulators.
• Experience with hermetic packaging, titanium housings, ceramic components, feedthroughs, brazing, and laser welding.
• Experience with implantable connectors, seals, or electrical isolation features.
• Experience with long-term implantable materials and biocompatibility considerations.
• Experience with mechanical reliability and accelerated life testing.
• Experience taking a medical device from concept to early feasibility studies, through V&V, and commercial release.
• Experience with supplier development and manufacturing transfer.

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.