Senior Mechanical Design Engineer

About the Company

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. Our products have empowered thousands of people to get back to their lives with confidence and ease.

Responsibilities

• Lead mechanical design and reviews, managing complex schedules and technical requirements
• Design high-fidelity prototypes to facilitate usability studies and requirements characterization
• Define comprehensive testing plans, develop custom test methods and fixtures, and lead mechanical verification
• Support design control documentation and lead engineering change orders (ECOs)
• Drive manufacturing transfers and partner with production teams for continuous improvements
• Diagnose, document, and support the Quality Management System, including NCMRs and CAPAs

Requirements

• 5+ years of experience in mechanical engineering with a focus on electromechanical systems
• Experience taking a Class II medical device from initial design through FDA 510k approval and manufacturing transfer
• Expert-level SolidWorks skills including complex surfacing and tolerancing
• Proficiency in GD&T and statistical analysis (DOE)
• Knowledge of DFM processes including injection molding, silicone molding, machining, and 3D printing
• Familiarity with medical device standards such as IEC 60601-1 and ISO 10993
• BS in Mechanical Engineering or a related technical field

Preferred Qualifications

• Experience with wearables or high-touch consumer electronics design