Senior Mechanical Engineer

Role Overview

As a Senior Mechanical Engineer, you will own the mechanical architecture, design, development and scale of a brain-space active implantable product toward high-volume manufacturing, working closely with contract manufacturing partners. You'll take a design through human-factors testing, design verification, and into full-scale production.

Primary Role and Responsibilities

• Device Design Refinement: Evolve mechanical assemblies — hermetic enclosures, ultra-fine multi-lumen components, connectors, and surgical deployment tools — optimizing for manufacturability and reliability.
• Contract Manufacturer Collaboration: Serve as primary technical point of contact for contract manufacturers, driving joint development, process characterization, resolving yield and quality issues, and holding CMs accountable to design intent, timelines, and quality.
• Materials Application: Apply and validate biocompatible materials (titanium, platinum-iridium, specialized polyurethanes, silicones) for chronic implantation, fatigue resistance, and biostability.
• Tolerance & Stress Analysis: Perform FEA for stress, strain, and fatigue, plus GD&T, to ensure manufacturability.
• Cross-Functional Collaboration: Partner with Electrical Engineering (circuitry and hermetic feedthrough integration), Neurosurgeon/Neurologist, and Clinical/Regulatory teams.
• V&V: Draft test protocols and execute/manage mechanical testing (tensile, flex-fatigue, leak, environmental stress cracking) to meet FDA and ISO 14971 standards. Own reliability testing DOEs beyond V&V to explore/capture corner cases failure modes.
• DFM/DFA: Develop and refine processes for laser welding, micro-molding, and automated assembly of sub-millimeter components with CM partners.

Qualifications

• Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or Materials Science (Master's or Ph.D. preferred).
• 7+ years of mechanical design experience, ideally with Class III active implantable medical devices, including taking designs through V&V, DFM, and into production
• Demonstrated experience managing or partnering with contract manufacturers on process transfer, tooling qualification, and scale-up
• Advanced proficiency in SolidWorks, PTC Creo, or equivalent 3D modeling software
• Deep understanding of micro-machining, injection molding, hermetic sealing, and the mechanical challenges of ultra-flexible, multi-contact implantable components
• Familiarity with FDA 21 CFR Part 820, ISO 13485, and ISO 14708 (active implantable devices)Meticulous attention to detail, a passion for complex spatial problem-solving, and empathy for the patients who rely on this technology