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Salary: USD 125,000 - 180,000 / annual
Cala Health is developing non-invasive prescription therapies for chronic disease, starting with neuromodulation devices for hand tremor and expanding into neurology, cardiology, and beyond. As Senior Mechanical Design Engineer, you will drive the design, development, and testing of these revolutionary devices from early-stage prototyping through manufacturing at scale.
Key responsibilities include:
- Lead mechanical design and design reviews, managing complex schedules and technical requirements throughout development
- Design high-fidelity prototypes to support usability studies and requirements characterization
- Define comprehensive testing plans, develop custom test methods and fixtures, and lead final product mechanical verification
- Support design control documentation and lead engineering change orders (ECOs) to maintain product integrity
- Drive manufacturing transfers and partner with production teams on continuous improvements
- Diagnose and support the Quality Management System, including NCMRs and CAPAs related to mechanical design
You will work in a dynamic, fast-paced startup environment where your expertise directly impacts products that help thousands of people manage chronic disease.
Requirements:
- BS in Mechanical Engineering or related technical field
- 5+ years of mechanical engineering experience with focus on electromechanical systems and early clinical study support
- Demonstrated experience taking a Class II medical device from initial design through FDA 510(k) approval and transfer to manufacturing for commercialization
- Strong Design for Manufacturing (DFM) mindset with knowledge of plastic injection molding, silicone molding, machining, PCB fabrication/assembly, and 3D printing
- Experience working with Contract Manufacturing partners on development-to-production transitions
- Expert-level SolidWorks proficiency, particularly with complex surfacing, manufacturability, and tolerancing
- Familiarity with medical device standards including IEC 60601-1 (safety/essential performance) and ISO 10993 (biocompatibility)
- Demonstrated experience with medical device phase-gate development, risk analysis, design control practices, and root cause analysis
- Proficiency in GD&T and statistical analysis (such as DOE) to inform design decisions
- Experience with wearables or high-touch consumer electronics design is a plus
- Must be authorized to work in the United States on a full-time basis or eligible for work authorization through a sponsorship path Cala supports
