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 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.
• Responsibilities 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. Required Education Bachelor's degree in Mechanical Engineering or a related engineering discipline.
• Required Qualifications 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.
• Preferred Qualifications 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. Powered by JazzHR