Staff Mechanical Engineer

About the role

We are seeking 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.

Responsibilities

• Mechanical Design
• 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.
• Design Verification & Validation
• 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.
• Test Equipment & Fixture Development
• 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.
• Product Development
• 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.
• Support contract manufacturers to resolve design and manufacturing issues.
• Cross-Functional Leadership
• 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.

Qualifications

• 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.

Preferred Qualifications

• 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.