Staff Mechanical Engineer

Epia Neuro•Alameda, CA

2d•Onsite

About The Position

Epia Neuro is a neural technology company developing intent-driven systems designed to restore function and independence for people living with neurological conditions. Its platform integrates implantable neural interfaces, adaptive algorithms, and assistive devices to translate neural intent into real-world action. The company’s initial focus is stroke-related motor impairment, with expansion in cognitive decline and other neurological disorders, focusing on long-term solutions for the growing aging population. We're looking for a Staff Mechanical Engineer to lead the development and verification of next-generation implantable and external neurotechnology systems. This role combines mechanical design, design verification, fixture development, and system integration across implantable and wearable medical devices. You will serve as the technical owner for the mechanical development and verification of critical subsystems including implantables, surgical tooling, and rehabilitation hardware. Additionally, you will define the verification strategies that demonstrate these devices are safe, reliable, and ready for clinical use. Working within the Testing organization, you will collaborate closely with the Hardware, Robotics, Firmware, Quality, and Regulatory Teams to take products from prototype through verification and into production.

Requirements

Bachelor's degree in Mechanical Engineering, or related field.
8+ years of mechanical engineering experience developing medical devices.
Extensive experience designing precision mechanical systems.
Strong proficiency using SolidWorks (or equivalent professional CAD software).
Experience developing products under FDA Design Controls and ISO 13485.
Experience developing verification protocols, reports, and mechanical test methods.
Strong understanding of mechanical testing principles, including fatigue, durability, environmental, and reliability testing.
Experience supporting design verification activities.
Experience developing custom test fixtures and automated laboratory equipment.
Excellent written and verbal communication skills.

Nice To Haves

Experience developing Class III implantable medical devices.
Familiarity with standards applicable to Class III active implantable medical devices, including ISO 14708, ISO 10993, IEC 60601, and ASTM mechanical testing standards.
Experience designing miniature implantable devices.
Experience supporting regulatory submissions.
Strong understanding of medical device risk management and design controls.

Responsibilities

Lead the mechanical design of implantable and external medical device subsystems.
Generate detailed CAD models, drawings, and manufacturing documentation.
Build, assemble, and evaluate mechanical prototypes to rapidly iterate designs and reduce technical risk.
Evaluate design concepts, perform tolerance analyses, and participate in design reviews.
Collaborate with manufacturing partners and external vendors to optimize designs for manufacturability and reliability.
Develop comprehensive mechanical verification strategies for implantable and external systems.
Analyze verification data, identify failure modes, and recommend design improvements.
Author verification plans, protocols, acceptance criteria, reports, and traceability documentation.
Develop mechanical test methods consistent with applicable medical device standards.
Execute and analyze verification testing including tensile, compression, fatigue, vibration, environmental, durability, and functional testing.
Investigate failures, perform root cause analysis, and drive corrective design improvements.
Support design validation activities and clinical readiness.
Design and develop custom mechanical test fixtures and tooling to support design verification activities.
Improve the efficiency and repeatability of mechanical testing through fixture design and standardized test methods.
Own and operate mechanical test equipment, including universal testing machines (e.g., Instron), force gauges, and torque testers.
Participate in requirements development, risk analysis, design reviews, and design control activities.
Support prototype builds, engineering evaluations, and design iterations throughout the product development lifecycle.
Support transition from prototype through manufacturing and production.
Generate Design History File documentation supporting regulatory submissions.
Work closely with contract manufacturers to resolve design and manufacturing issues.
Serve as the primary mechanical engineering resource within the Testing organization.
Collaborate with Hardware, Firmware, Quality, and Regulatory throughout product development.
Provide technical leadership for mechanical verification activities.
Mentor junior engineers and establish best practices for mechanical design and testing.