SummaryAt 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 ExperienceWe 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.
