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About the Role
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.
Responsibilities
- Evolve mechanical assemblies — hermetic enclosures, ultra-fine multi-lumen components, connectors, and surgical deployment tools — optimizing for manufacturability and reliability.
- 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.
- Apply and validate biocompatible materials (titanium, platinum-iridium, specialized polyurethanes, silicones) for chronic implantation, fatigue resistance, and biostability.
- Perform FEA for stress, strain, and fatigue, plus GD&T, to ensure manufacturability.
- Partner with Electrical Engineering (circuitry and hermetic feedthrough integration), Neurosurgeon/Neurologist, and Clinical/Regulatory teams.
- 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.
- Develop and refine processes for laser welding, micro-molding, and automated assembly of sub-millimeter components with CM partners.
Requirements
- 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.
Skills
- Mechanical Architecture
- Design
- Development
- Scale
- High-Volume Manufacturing
- Human-Factors Testing
- Design Verification
- Production
- Hermetic Enclosures
- Multi-lumen Components
- Connectors
- Surgical Deployment Tools
- Manufacturability Optimization
- Reliability Optimization
- Contract Manufacturer Collaboration
- Process Characterization
- Yield Improvement
- Quality Improvement
- Biocompatible Materials Application
- Titanium
- Platinum-Iridium
- Polyurethanes
- Silicones
- Chronic Implantation
- Fatigue Resistance
- Biostability
- FEA
- Stress Analysis
- Strain Analysis
- Fatigue Analysis
- GD&T
- Electrical Engineering Integration
- Neurosurgeon Collaboration
- Neurologist Collaboration
- Clinical Team Collaboration
- Regulatory Team Collaboration
- V&V
- Mechanical Testing
- Tensile Testing
- Flex-Fatigue Testing
- Leak Testing
- Environmental Stress Cracking Testing
- FDA Standards
- ISO 14971 Standards
- Reliability Testing
- Failure Mode Analysis
- DFM
- DFA
- Laser Welding
- Micro-molding
- Automated Assembly
- SolidWorks
- PTC Creo
- Micro-machining
- Injection Molding
- Hermetic Sealing
- Ultra-flexible Components
- Multi-contact Implantable Components
- FDA 21 CFR Part 820
- ISO 13485
- ISO 14708
Location
- Remote
Work Type
- Full-time
Experience Level
- Senior
- 7+ years
Education Level
- Bachelor's Degree
- Master's Degree
- Ph.D.
Salary/Compensations
- $150,000—$215,000 USD
Benefits
- Competitive compensation
- Stock options
- Comprehensive benefits package
- 401(k) program with matching contributions
About the Company
- Echo Neurotechnologies is an exciting new startup in the Brain-Computer Interface (BCI) space, driving innovation through advanced hardware engineering and AI solutions.
- Our mission is to deliver cutting-edge technologies that restore autonomy to people living with disabilities and improve their quality of life.
- Join a small, dedicated team of knowledgeable and motivated professionals.
- Our early-stage environment offers the opportunity to take ownership of broad decisions with significant and long-lasting impact.
- We emphasize continuous learning and growth, fostering cross-functional collaboration where your contributions are vital to our success.
Equal Opportunity
- Echo Neurotechnologies is an Equal Opportunity Employer (EOE). We celebrate diversity and are committed to creating an inclusive environment for all employees.