Staff Mechanical Engineer
$150,000–$200,000 year
On-siteAlameda, California, United States
Alameda, California, United StatesOn-siteFull Time$150,000–$200,000 yearSenior LevelStartup
Full TimeSenior LevelStartup
Job Summary
Lead mechanical design and verification of implantable and external neurotechnology subsystems, including generating CAD models, building prototypes, and executing fatigue, environmental, and durability testing. Develop comprehensive verification strategies, test fixtures, and documentation to support FDA submissions and clinical readiness while collaborating with Hardware, Firmware, and Regulatory teams. Drive root cause analysis for failures and mentor junior engineers within the Testing organization. Based in Alameda, CA, with on-site requirements five days a week.
Required 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
Desired 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
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