Senior Mechanical Design Engineer

Cala Health • San Mateo, CA

6h

About The Position

At Cala, we’re working to free people from the burden of chronic disease. We began by creating the first non-invasive prescription therapy for hand tremor. After years of careful fine-tuning and improvements, we released Cala kIQ — our most sophisticated therapy yet. Our products have empowered thousands of people to get back to their lives with confidence and ease.

As Senior Mechanical Design Engineer, you will be a key driver in the design, development, and testing of our revolutionary neuromodulation therapy devices. You will work on projects from early-stage prototyping all the way through manufacturing at scale, ensuring Cala’s products meet the highest standards of quality, reliability, and usability.

Requirements

• 5+ years of experience in mechanical engineering, with a strong focus on electromechanical systems and early clinical study support.
• Has taken a Class II medical device all the way from initial design through FDA 510k approval and transfer to manufacturing for commercialization.
• Design for Manufacturing (DFM) mindset, including knowledge of diverse processes including: plastic injection molding, silicone molding, machining, PCB fabrication/assembly, and 3D printing.
• Experience working with Contract Manufacturing partners to smoothly transfer development activity into production environment.
• Expert-level SolidWorks skills, specifically with complex surfacing, manufacturability, and tolerancing.
• Familiarity with medical device standards, such as 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.
• GD&T, proficiency in statistical analysis (such as DOE) to inform design decisions and verification results.
• BS in Mechanical Engineering or a related technical field.

Nice To Haves

• Experience with wearables or high-touch consumer electronics design a plus.

Responsibilities

• Lead mechanical design and reviews, managing complex schedules and technical requirements throughout the development process.
• Design high-fidelity prototypes to facilitate usability studies and requirements characterization.
• Define comprehensive testing plans, develop custom test methods and fixtures, and lead final product mechanical verification activities.
• Support design control documentation and lead engineering change orders (ECOs) to maintain product documentation and integrity.
• Drive manufacturing transfers and partner with production teams to identify, propose, and implement continuous improvements.
• Diagnose, document, and support Cala’s Quality Management System, including any NCMRs and CAPAs related to mechanical design.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior