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 recently released kIQ® Plus, 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 beyond. 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.
The compensation range for this role is market driven, with a salary range of $125,000 - $180,000. Additionally, we offer a robust benefits package. This offering is aligned with our overall compensation philosophy. Final compensation is based on experience, skills, market benchmarks, and internal equity, with potential adjustments for candidate location.
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.
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:
- Education: BS in Mechanical Engineering or a related technical field.
- 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.
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.
Skills Required
- Bachelor’s degree in Mechanical Engineering or a related technical field
- 5+ years of mechanical engineering experience
- Strong experience with electromechanical systems and early clinical study support
- Experience taking a Class II medical device from initial design through FDA 510(k) approval and manufacturing transfer
- Design for Manufacturing experience with plastic injection molding, silicone molding, machining, PCB fabrication and assembly, and 3D printing
- Experience working with contract manufacturing partners to transfer development into production
- Expert-level SolidWorks skills, including complex surfacing, manufacturability, and tolerancing
- Familiarity with IEC 60601-1 and ISO 10993 medical device standards
- Experience with medical device phase-gate development, risk analysis, and design controls
- Root cause analysis experience
- GD&T proficiency
- Statistical analysis proficiency, such as Design of Experiments (DOE)
- Experience designing wearables or high-touch consumer electronics
What We Do
Cala Health is a bioelectronic medicine company transforming the standard of care for chronic disease. The company’s wearable neuromodulation therapies merge innovations in neuroscience and technology to deliver individualized peripheral nerve stimulation. The first indication for Cala Health’s wearable therapy is essential tremor, a disease experienced by more than seven million people and characterized by severe hand tremors. New therapies are under development in neurology, cardiology, and psychiatry. The company is headquartered in the San Francisco Bay Area and backed by leading investors in both healthcare and technology. #EssentialTremorAwarenessMonth
