Senior Mechanical Design Engineer

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.

Summary

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 essential 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. Specific

Responsibilities

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.

Skills

and Experience We are looking for a Senior Mechanical Design Engineer to support product development in a dynamic fast-paced startup environment exemplified by Technical Expertise 5+ years of experience in mechanical engineering with a strong focus on electromechanical systems and early clinical study support. Practical Experience Has taken a Class II medical device all the way from initial design through FDA 510k approval and transfer to manufacturing for commercialization. Experience with wearables or high-touch consumer electronics design a plus. Manufacturing Fluency 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. Advanced CAD Expert-level SolidWorks skills specifically with complex surfacing manufacturability and tolerancing. Regulatory Knowledge Familiarity with medical device standards such as IEC 60601-1 (safety/essential performance) and ISO 10993 (biocompatibility). Quality & Rigor Demonstrated experience with medical device phase-gate development risk analysis design control practices and root cause analysis.

Analytical Skills

GD&T proficiency in statistical analysis (such as DOE) to inform design decisions and verification results. Education BS in Mechanical Engineering or a related technical field. 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. Sponsorship decisions are made individually based on role timeline and cost considerations and are not guaranteed. Cala Health believes our success is based on diversity of people teams and thinking.

We offer

all employees the tools training and mentoring they need to succeed. Our selection process is driven by the key requirements for the role rather than bias or discrimination on the basis of a candidate’s sex gender identity age marital status veteran status non-jobrelated disability/handicap or medical condition family status sexual orientation religion color ethnicity race or any other legally protected classification.