Senior Mechanical Design Engineer

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.