As a Senior Mechanical Engineer leading New Product Introduction, you will play a central role in transforming innovative BCI designs into producible, high-integrity medical systems. You'll work across engineering and manufacturing to ensure that mechanical components meet performance, quality, and regulatory standards from concept through volume production.
What You'll Do
- Collaborate with R&D teams to refine designs for scalability, durability, and ease of manufacturing
- Develop and validate CAD models, detailed 2D drawings, and tolerance analyses to support robust assembly processes
- Define and implement inspection methodologies and metrology approaches for critical components
- Design and oversee the development of custom fixtures and tooling to ensure process consistency
- Lead design and process FMEA activities to proactively address potential failure modes
- Investigate and resolve complex technical issues involving materials, fabrication methods, or assembly performance
- Manage relationships with contract manufacturers, guiding teams and processes across machining, polymer processing, and electronics integration
Requirements
- Bachelor’s degree in Mechanical Engineering or a related discipline
- At least 7 years of experience in medical device product development
- Proven expertise with CAD platforms such as Solidworks
- Hands-on involvement in prototyping, testing, and process validation
- Solid understanding of plastic and metal component manufacturing, adhesives, PCBs, and cable assemblies
- Strong background in geometric dimensioning, tolerance stack-up analysis, and inspection techniques
- Direct experience managing external manufacturing partners
- Familiarity with quality management systems and regulatory requirements for medical devices
Benefits
- Comprehensive health, dental, and vision coverage
- 401(k) plan with company match
- Equity through stock options
- Competitive salary based on experience
- Work on transformative technology with measurable patient impact
- Collaborative culture emphasizing ownership, innovation, and continuous growth
