Senior Mechanical Design Engineer

Cala Health • San Mateo, CA

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About The Position

About Cala
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.
But we won’t stop there. Our pioneering technology can be applied across neurology, cardiology, and so much more. It’s all part of our mission to help people in their struggle with chronic disease. We’re only just getting started.
The Role
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.
AI Disclaimer: Cala does not permit the use of AI during interviews and technical testing so that we can property assess thought process and skillset.
A Day In The Life
Mechanical Design Leadership: Lead mechanical design and reviews, managing complex schedules and technical requirements throughout the development process.
Prototyping & Testing: Design high-fidelity prototypes to facilitate usability studies and requirements characterization.
Verification & Validation: Define comprehensive testing plans, develop custom test methods and fixtures, and lead final product mechanical verification activities.
Lifecycle Management: Support design control documentation and lead engineering change orders (ECOs) to maintain product documentation and integrity.
Manufacturing & Sustaining: Drive manufacturing transfers and partner with production teams to identify, propose, and implement continuous improvements.
Quality Compliance: Diagnose, document, and support Cala’s Quality Management System, including any NCMRs and CAPAs related to mechanical design.

Requirements

• BS in Mechanical Engineering or a related technical field.
• 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.
• Applicants must be authorized to work in the United States on a full-time basis, or eligible for work authorization through a sponsorship path that Cala Health is able to support.

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